Making A Move To The Hamptons

luxury home for sale

Live Like A Celebrity And Move To The Hamptons

Given that it is such a brief travel from New York or even New Jersey, the unbelievable amount of natural beauty that exists here in East Hampton is extremely astonishing. If you haven’t been here, there are these long stretches of blue Coast lines that are flowing with golden sands. In addition, the natural landscapes that exist, there are also plenty of city parks that unite to form one of the most relaxing and breathtaking destinations along the upper East Coast. If you live near here and you have money, then you know about the Hamptons! There are mega movie stars and musicians that own beautiful property here, which as a result has attracted fantastic restaurants and dining establishments for those that like the finer things in life. There are posh boutiques popping up all over town, and despite its prevalence, however, East Hampton has worked tirelessly to keep its village-like charm, something you will quickly if you visit on vacation or decide to move to the Hamptons. There are few moving companies we trust in New York and New Jersey to move families into the Hamptons, but the team at Bluebell Moving And Storage has proven time and time again that they are the East Coasts premier moving agency for the upper class on the East Coast

As A New Resident Prepare To Shop And Surf The Hamptons

Due to its astonishing landscape, perfect location, and natural abundance of awesomeness, East Hampton has a lot of activities for you to get into once you move to the Hamptons. Main Beach is the biggest attraction for a lot of East Hampton locals and visitors. Believe it or not, it is among some of the best-ranked shorelines in the country, but it is more than just a place to relax on the beach and soak in some sun rays. Main Beach hosts many of the college’s water sports competitions, there is surfing, biking, paddle boarding, body surfing, and boogie boarding. Those of you that prefer spending money on fashion, you will love what Main Street has to offer, with its fashionable posh boutiques, they cater to the upper class that has money to spend on the nicer things in life. If that is not you, don’t bother moving here because poor people don’t fit in.

Embrace The Lavish Culture Of The Hamptons

If you can tear yourself away from the shore, the city of East Hampton has lots of family-friendly attractions to check out during the day and in the evenings. One of the true gems of Long Island is LongHouse Reserve. The beautifully maintained garden stretches 16 acres across the Hamptons and is filled with amazing eye-catching stone sculptures. The Pollock-Krasner House (once home to the artists Jackson Pollock and Lee Krasner) is just another location that civilization aficionados will not want to miss out on checking out, true history at it’s finest. Folks of all ages will love the fascinating tour, and children will love making their very own Pollock-style drip paintings. Living in the Hamptons offers so many great things to enjoy, and those are just a few. Becoming culturally aware of art and the area will be necessary if you are going to fit in here.

If You Are Lucky Enough To Buy Shorefront Property

If you are lucky enough to buy shorefront property you better soak it up! Most families that buy into this luxury area don’t give up their property that easy. move to the hamptons - family home in east hamptonHouses and land are passed down through the generations over the years and children and grandchildren are often left with vacation homes they rather not sell. The experience living on the shore is unforgettable. Even though the months of June through August are the nicest, September is also a fantastic time to enjoy some good sun and good times. If you are not a sun worshiper, late spring is also an amazing time of year. Temperatures are somewhat milder, but East Hampton nonetheless retains its magical, village-like vibe. For those that want to move to the Hamptson this vibe is priceless, for visitors making a vacation of the Hamptons, they often times do not want to leave!

If You Make The Move To The Hamptons Enjoy The Parks

When you move here you may find that there is an overwhelming amount of things to do at first. Moving in, unpacking, finding your way around and all that fun stuff. But after you get settled, you need to check out the Hampton Parks. East Hampton is home to no less than 8 country parks and two county parks, with Cedar Point County Park being the most popular destination among local residents and out of town visitors. It encompasses over 600 acres of coastal beauty and is famous for its magnificent views of Gardiner’s Bay. There is an abundance of things to do such as fishing, hiking, biking, and playing in the park. Additionally, It plays host to a rich ecosystem of wildlife together with everything from deer to ducks. There are also designated dog areas for the dog lovers of the Hamptons. The rich love their poodles and purse dogs, there is no shortage of those dogs here in our parks. Locals take pride in their parks and we ask that if you move to the Hamptons that you bring your dog out to enjoy the natural beauty with you that you clean up after your animal if they poop in the park grass.

READ: New Jersey Proposes New Limits……

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Why You Need Orthodontic Insurance Coverage

Why You Need Orthodontic Insurance Coverage

Insurance insures help patients when they want financial aid to obtain the needed service and have a difficulty. Such policies are used by them as a threat coverage tool, and one main policy folks take, is orthodontic insurance if they have been aware about their oral health. Correcting abnormalities and dental issues like misaligned or damaged teeth can improve grin and an individual’s facial features. Sadly, the prices can bite difficult in the lack of quality insurance. Dental treatment from Sky Orthodontist Oklahoma City changes among individuals so, the adolescents; therefore, many parents are under pressure in the adolescents who need to wear good looking braces.

Things become a lot simpler as the cover protects all processes and gear when you’ve got insurance insuring an orthodontist’s treatment. Check whether the policy contains coverage of treatment if you’ve got an existing dental insurance. Should it not have, then contemplate purchasing a supplementary form especially for this to cover your treatment prices. It’ll save you big time if you’ve got family members that want braces or treatment.

Just like your dental or insurance coverage that is routine, you’ll need to pay a monthly or annual premium. More than a few companies pay as much as fifty percent of the overall care expenses. So, if treatment is required by some of your nearest and dearest at once, your financial weight can ease significantly.

A bulk of the expenses come from the price of gear used in the restoration procedure like other additional dental products, braces, and retainers. The price of dental x rays, allowances that are needed, and monthly visits influence the amount being spent on treatment making it higher as opposed to dental care services that are routine. Averagely, the supplier to cater up to a specific quantity of dental care per year after which the maximum annual sum for all the dental prices become your company was just wanted by the typical dental cover.

In several cases, such processes are seen by individuals as being just decorative thus resulting in just several insurance companies providing cover for such a treatment services.

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Is It Necessary To See A Dentist Frequently?

Is It Necessary To See A Dentist Frequently?

The prevention of periodontal disease, cavities, and bad breath is reached with oral direction techniques which are powerful and affordable, easy to perform on a daily basis. A professional should be consulted or more often depending on significant care attempts and dental demands. Dentist OKC offers complete oral health care services to patients to help in the care of a cavity grin that is free. Personal wellness techniques and advanced oral technology are supplied according to individual conditions.

The oral evaluation can discover changes and tooth issues in tissues indicative of major ailments including cancers and diabetes. Some of the most significant measures that people can take to maintain the healthy state of teeth would be to see with the dental offices frequently. A routine checkup contains the detection of tartar, plaque and cavities in charge of gum disease and tooth decay. The formation of a failure and bacteria can improve discoloration, oral deterioration and decay. A failure to correct oral issues including little cavities may lead to important destruction of tissue and enamel including tooth loss and acute pain.

A dentist will counsel patients on easy and affordable suggestions for health care care that is individual to grow strong teeth and gums. This can be a simple and affordable method shield the state of oral tissues and to prevent cavities. Specialized tools are integrated at the practice to supply a professional clean and accomplish places that cannot be reached with flossing and brushing. It shields against spots and decay that undermine the healthy state of pearly whites. A dental practice provides complete oral care helping in treating gum and tooth ailments. Meeting an oral professional often and following day-to-day hygiene measures can best protect and improve the state of your grin.

It is important to get it assessed time to time and to take good care of your dental health and stay healthy. Google “oral health”  if you want to learn more about the oral health.

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Things To Look For In An Attorney Before Hiring Them

Things To Look For In An Attorney Before Hiring Them

Permit me to start by saying that do it yourself has its limitations. Certainly, contracts can be drafted by you by yourself, it is possible to survive discussions that are grotesque with your company customers, a married dispute can be settled by you but you should get an attorney when the demand to come to court appears. Expenses will be incurred, professional fees must be paid and the normally drawn-out procedure must be born. The prices of solving a difficulty are much greater in relation to the prices of preventing the issue. However, hiring a Sugar Land criminal defense attorney can eliminate the complexity, who knows what needs to be done.

When locating a lawyer so, search for a “competent” attorney. Before you start to share your innermost secrets together it’s absolutely ethical to require a lawyer permit. Generally though, their certifications would hang. He may be a professional in any among the following types of law: taxation law, labor law, civil law, international law, litigation, or criminal law. These are the important types. Therefore, you may learn of an immigration lawyer or a litigation attorney. Note however, that attorneys’ specialties are “obtained” through expertise, not only because they believe they have been excellent at it.

This can be one facet of being a lawyer where a youthful, inexperienced attorney can in fact get ahead of a seasoned one. Young attorneys usually are sympathetic, encouraging and lively. They have a tendency to treat their customers like their infants. They take care of every small detail, even the ones that are unimportant. But this just is paying customers desire to be treated. Customers often believe that they’re getting their money’s worth with the type of focus they can be becoming.

The personal qualities to try to find in an attorney depend significantly on the type of customer you might be. Should you be the no nonsense sort, you may choose to hire an old attorney who is about to retire. These kinds of attorney are interested in what you will need to say. Occasionally, they’re not thinking about what they must say. But their expertise is impeccable. The credibility of an attorney may be viewed in several circumstances. It can be built on charm coupled with referrals from previous satisfied customers. To be sure, no attorney can get customers if he’s not trustworthy and believable.

So at this point you have a credible, skilled and competent injury attorney having the individual qualities you try to find. Another matter to contemplate is whether that attorney can be acquired to attend to your own issue. Your attorney will say he is capable, willing and happy to help you. He said the identical thing to last week, and several others this morning, and the week. The point is, an attorney can only just do so much. He can not all be attending hearings all. He’d likely resort to rescheduling or cancelling hearings and assemblies that are significant to make ends meet. If your preferred attorney has a law firm, there will surely be other attorneys who can attend in case he is unavailable to you personally. You’ll find this satisfactory but not until your case continues to be reassigned to another from one hand.

The representation starts when you meet with your customer. This, nevertheless, isn’t what defines professionalism. So don’t be misled by the attorney-appear alone. It’d be amazing if your attorney can pull it away with the professionalism that is authentic and the attorney appearance though.

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Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin

Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin

By Sara W. Koblitz

As we move in to 2020, FDA is fastidiously preparing for the event 10 years in the making: the transition.  For those of you unfamiliar with the “transition,” it refers to the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act.  The 2010 statute amended the statutory definition of a “biological product” to include “a protein (except any chemically synthesized polypeptide),” and this definition is officially in effect as of March 2020.  As a result, almost 100 approved NDAs will automatically transition into BLAs on March 23, 2020.  On the same date, FDA will no longer accept applications under section 505 of the FDCA for protein products, and any pending drug applications (other than supplements) will receive a Complete Response.

The most notable product undergoing the “transition” is insulin.  Given the high costs of insulin that limit product accessibility, FDA is anxious to get more insulin products on the market.  As a drug, insulin sponsors have had difficulty scientifically demonstrating the requisite “sameness” needed for generic approval.  For that reason, as well as technical advances in delivery, most insulin products were approved under 505(b)(1) or 505(b)(2) NDAs (a look at the Orange Book shows that FDA has never approved an ANDA for generic insulin).  But as a biologic, putative “generic” insulin manufacturers no longer have to demonstrate “sameness” – only that their insulin products are “highly similar” to the reference product.  While their products are not “generic” – and not interchangeable until sameness can be demonstrated – the 351(k) biosimilar pathway makes it a little easier for new insulin products to come to market provided that analytical studies demonstrate that there are no clinically meaningful differences between biosimilar and reference product safety, purity, and potency.

To “enable a more robust route for developing lower cost copies of insulin,” a commitment the Agency undertook under the watch of Commissioner Gottlieb and appears to be continuing under Acting Commissioner Giroir, FDA issued a draft guidance last week designed to “facilitate the development of, and improve patient access to, life-saving insulin [biosimilar and interchangeable] products.”  The guidance is intended to inform developers on the data an information necessary to support a demonstration of biosimilarity or interchangeability for an insulin product.  Part of the Biosimilars Action Plan, the guidance is focused specifically on “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”

The guidance explains that FDA has typically recommended the submission of clinical immunogenicity studies for the approval of insulin drug products under the 505(b) pathway and that FDA has previously stated that the same is expected in any 351(k) insulin applications.  However, FDA has now “updated its thinking” with respect to clinical immunogenicity studies: the Agency now believes that if a comparative analytical assessment supports demonstration of “highly similar” for a proposed biosimilar or interchangeable insulin product, there should be little uncertainty regarding immunogenicity, and comparative clinical immunogenicity studies may not be required.  While this isn’t the case for all biosimilar or interchangeable insulin products and FDA will analyze on a case-by-case basis for individual applications, the presumption is no longer that such studies are required.   FDA attributes this shift to “the evolution in the understanding and extensive characterization of protein products” arising from technological improvements, particularly with respect to small, well-understood, well-characterized, and structurally uncomplicated proteins like insulin.

FDA also uses this guidance to explain its expectations for data to support a demonstration of biosimilarity or interchangeability in a 351(k) for insulin.  In addition to “a robust and comprehensive comparative analytical assessment demonstrating that the proposed insulin product is ‘highly similar’ to its proposed reference product with very low residual uncertainty regarding immunogenicity” and an immunogenicity assessment justifying why a comparative clinical study to assess immunogenicity is not necessary, FDA expects to see adequate chemistry, manufacturing and controls information, a comparative clinical pharmacology study between the proposed insulin product and the reference product, and a comprehensive and robust comparative analytical assessment to show that the insulin product is “highly similar” to the reference product.

While, in theory, a sponsor could submit a 351(k) aBLAs for insulin before March 2020, this can only happen if an insulin reference product is approved under a BLA.  Since the “transition” of the approved insulin NDAs does not officially happen until March 2020, there is no reference product on which a biosimilar insulin application can currently rely.  (Though FDA could start approving insulin products under BLAs in 2010, the Purple Book does not show any approved insulin BLAs.)  Upon that transition though, when insulin becomes a valid biosimilar reference product, there will likely be many insulins vying for approval.  This guidance suggests that FDA will exercise some flexibility in its requirements for biosimilar insulin, helping the agency bring additional insulin products to market more quickly in an effort to address the dire need for these products.

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HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger

HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger

Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Deborah L. Livornese and Serra J. Schlanger have become its newest directors.

Deborah’s practice covers a broad range of FDA regulatory issues.  She assists pharmaceutical drug companies of all sizes on drug development and regulatory  strategies related to obtaining FDA approval, as well as on post-marketing regulatory requirements, including drug promotion and advertising. Ms. Livornese also assists clients in connection with commercial transactions and public offerings by conducting FDA regulatory due diligence on behalf of regulated companies and potential investors and purchasers.

Deborah spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research prior to joining HPM in 2018. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, opioid drugs, and user fee programs.

Prior to joining FDA, Deborah was Of Counsel with an FDA boutique law firm in Washington DC where she advised drug companies on promotional activities for compliance with FDA, FTC and HHS requirements, and assisted clients in responding to investigational findings, warning letters, and inquiries from the FDA and other agencies.  Her full bio can be found here.

Serra joined HPM in July 2016.  Prior to joining the firm, Serra was an associate in the health care and life sciences practice of a national law firm.  Before beginning her legal career, Serra worked in clinical administration at Memorial Sloan-Kettering Cancer Center, gaining practical experience that she continues to draw upon when counseling clients.

Serra’s broad practice covers the intersection of health care and FDA law.  She works with clients across all of HPM’s practices areas.  Serra assists clients with a wide range of regulatory matters including developing regulatory strategy, drafting compliance policies and procedures, reviewing advertising and promotional materials, and evaluating and updating data privacy and patient health information policies and practices (HIPAA).  Serra has specific expertise with regard to federal and state health care fraud and abuse laws and defends clients in connection with government investigations and other enforcement inquiries.  She advises clients on the many legal and regulatory issues associated with telemedicine, laboratory developed tests (LDTs), and CLIA certification.  She also helps clients with contract matters and regulatory due diligence.  Serra was shortlisted for the 2019 LMG Life Sciences “US Rising Star – Regulatory” award.  Her full bio can be found here.

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FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020

FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020

By Karla L. Palmer

As we stated in our earlier blog post, on November 21, 2019, FDA released another draft guidance addressing compounding of animal drug products from bulk substances.  Recall that FDA first released its draft animal drug compounding guidance in 2015 (blogged about here).  With the release of that draft, FDA also withdrew its 2003 animal drug compounding guidance (Compliance Policy Guide Sec. 608.400).  FDA’s 2015 iteration of the compounding guidance was greeted with about 160 comments from industry.  Based on FDA’s consideration of those comments, it withdrew the draft guidance in 2017, which move likely reflected FDA’s significant struggle with determining its authority over animal drug compounding and the fact that the Drug Quality and Security Act (Title I, the Compounding Quality Act) and FDCA Section 503A by their terms do not apply to animal drug compounding.  Like the 2015 draft guidance, FDA’s latest attempt would exponentially expand FDA’s regulatory authority over veterinary medicine and the animal drug compounding space, which traditionally has been a state-regulated practice.  FDA likely will receive many comments on this latest draft, reflecting, among other issues, an alleged federal usurpation of state authority, and FDA’s overstepping through the use of guidance its limited statutory authority in the animal drug compounding space. Notably, the latest draft seems even more restrictive in terms of what may be compounded for use in animals than FDA’s withdrawn version.

Those interested in commenting on the draft should do so by February 18, 2020.  Comments should be submitted to this docket. (FDA-2018-D-4533).  In the Federal Register notice announcing publication of the draft, FDA states that it is specifically requesting comments on guidance section III.A.5, which provides that if that compounded drug contains the same active moiety as a marketed FDA-approved, conditionally approved or indexed drug, but as a different salt, ester, or other non-covalent derivative, there should be a difference between the compounded drug and the FDA approved, conditionally approved or indexed animal drug or FDA-approved human drug that will provide a clinical difference in the patient and the medical rationale is documented in the proscription.  If the veterinarian compounds the drug, the difference should be noted in the patient’s medical record.  Does this sound familiar?  It reminds this blogger of Congress’ prohibition on “essentially copies” of FDA-approved human drug products pursuant to Federal Food, Drug, and Cosmetic Act Sections 503A and 503B.  Notwithstanding, FDA states it is concerned that compounded versions (salts, esters, or non-covalent derivatives) of these products may affect the “absorption, distribution, metabolism excretion and stability of the compounded animal drug,” all of which factors contribute to a drug’s “safety and effectiveness.”  FDA also notes that compounding an animal drug from a different  salt, ester, ester, or other noncovalent derivative of the same active moiety as a marketed FDA-approved, conditionally approved or indexed animal drug or FDA-approved human drug may impact “incentives for seeking legal marketing status” of a new animal drug, and could serve as a disincentive for new animal drug sponsor to research or otherwise develop new animal drugs.

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FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process

FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process

By Karla L. Palmer

FDA recently released its latest revised draft guidance addressing compounding of animal drug products from bulk substances.  This iteration is not only a re-do of the draft guidance that FDA released in 2015 (blogged about here), but it also includes some new concepts such as a proposed animal drug “bulks” list with its own industry nomination process.  FDA’s 2015 attempt at crafting a guidance document for compounding of animal drugs from bulk substances was met with industry criticism, as set forth in the approximately 160 comments from industry that FDA received before it quietly withdrew that guidance draft in 2017.  As set forth below, FDA’s latest attempt would significantly expand FDA’s regulatory authority over veterinary medicine and animal drug compounding by both pharmacies and vets (which traditionally has been a state-regulated practice).

FDA’s announcement releasing the guidance states that it addresses particular situations concerning compounding animal drugs from bulk substances including: (1) filling patient specific prescriptions for nonfood-producing animals; (2) compounding for “office stock” from bulk drug substances for nonfood-producing animals; and (3) compounding antidotes for food producing animals.

The draft guidance spends many pages describing the “legal pathways” for marketing animal drugs and the Agency’s traditional exercise of enforcement discretion in certain circumstances when no other medically appropriate treatment options exist for the animal.  Akin to the statutory exemptions that Congress granted FDA for human drug compounding, FDA addresses those instances where it would — through the guidance document alone — exercise enforcement discretion for violations of the Federal Food, Drug, and Cosmetic Act’s (FDCA) requirements for animal drug approval, adequate directions for use and cGMP requirements if compounders meet the circumstances described in the guidance.  See Guidance at 4.  FDA expresses its most significant animal drug compounding “concerns” as the following: (1) when compounds present particular human or animal safety concerns; (2) are intended for use in food producing animals; (3) are copies of marketed FDA-approved, conditionally approved or indexed drug products; or, (4) are compounded without a patient specific prescription (i.e., for office stock).  FDA further states that the guidance would not apply in those instances involving investigations of new animal drugs, or those formulations compounded from marketed, FDA-approved (human or animal) drug products, which FDA’s considers extra label use (so long as FDA’s statutory and regulatory requirements for the same are met).

With many similarities to the 2015 draft that FDA rescinded in 2017, this draft guidance also addresses patient specific compounding in pharmacies and compounding for office stock (but omits specific mention this time of “outsourcing facilities”).  The most significant difference between the two drafts, however, is FDA’s request for nominations of bulk substances for its new animal drug bulk substances list, which — we note again — is not authorized by any federal statute, unlike the bulk substance nominations process for FDCA Sections 503A and 503B.

FDA’s guidance draft next details the Agency’s proposed use of enforcement discretion concerning: (1) patient specific prescriptions in nonfood producing animals (please pay particular attention to FDA’s onerous “copies” limitations in bullets 4-6, labeling, and adverse event reporting requirements); (2) compounding without patient specific prescriptions (i.e. office stock) for nonfood-producing animals (note in particular the bulks list reference/limitation at bullet 2, labeling and adverse event reporting requirements); and (3) compounding drugs for use as antidotes for treating toxicoses in food-producing animals, when (among compliance with other conditions listed in the guidance), using substances on FDA’s animal drug bulk substances list.

The “Bulks” Appendix

The Appendix to the draft guidance discusses FDA’s establishment of a public docket (FDA-2018-N-4626) for nominations and comments on bulk substances for (1) compounding office stock for use in nonfood-producing animals and (2) compounding antidotes for food-producing animals. Each nomination should be submitted as its own separate nomination.  FDA’s Appendix includes at pages 15-16 detailed information it expects to be included in the nominations.

FDA sets forth five general conditions for its bulks list, which are worth repeating verbatim here:

  1. There is no marketed FDA-approved, conditionally approved, or indexed animal drug that can be used as labeled to treat the condition;
  2. There is no marketed FDA-approved animal or human drug that could be used in an extra label manner under section 512(a)(4) or (a)(5) of the FD&C Act and 21 CFR part 530 to treat the condition;
  3. The drug cannot be compounded from a marketed FDA-approved animal or human drug consistent with 21 CFR part 530;
  4. Immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and
  5. FDA has not identified a significant safety concern specific to use of the bulk drug substance in animals.

(emphasis added).

If the bulk substance is to be used as an antidote in a food-producing animal, then, in addition to the above:

  1. There is sufficient scientific information for the veterinarian to determine appropriate withdrawal, withholding, or discard time(s) for meat, milk, eggs, or any food which might be derived from the treated animal(s).

Comments to the draft guidance are due February 18, 2020.  Any comments should be submitted to the following docket: Docket No. FDA-2018-D-4533.  Note this docket is different than the bulk substance nominations docket, at FDA-2018-N-4626.

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CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements

CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements

By Riëtte van Laack

FDA has repeatedly declared that cannabidiol (“CBD”) cannot be lawfully used in food or dietary supplements because FDA approved CBD as an active ingredient in an epilepsy drug before the first marketing of CBD as a dietary supplement or food.  This has not stopped the growth of the CBD industry, however.  The 2018 Farm Bill removed “hemp” from control under the federal Controlled Substances Act, which gave a boost to the hemp industry, and a patchwork of state rules has resulted in a proliferation of a wide array of CBD products.  Several states have passed legislation allowing the use of CBD in foods and supplements, but many other states have declared such uses illegal.  Although FDA maintains its position that the use of CBD in food and dietary supplements is illegal, FDA enforcement has been relatively minimal.

In testimony to before the Senate Committee on Agriculture, FDA asserted that it is exploring regulatory pathways available to hemp products containing CBD, but the Agency predicted that completing a potential rulemaking may take 3 – 5 or more years.  In a letter to FDA, a bipartisan group of members of Congress expressed its concern about this time line, suggesting that FDA announce a policy of enforcement discretion and consider the path of an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.

Meanwhile, industry has explored ways to get more clarity on CBD in dietary supplements and foods.  Early in October, four of the major trade associations, AHPA, CRN, CHPA and UNPA, seemingly frustrated by the state of affairs, sent a letter urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient for use in dietary supplements.

On November 14, 2019, CHPA (one of the signatories of the letter to Congress sent a month earlier) submitted a citizen petition requesting swift action from FDA regarding CBD.  Specifically, CHPA asks four things:

  1. Establishment of a regulatory pathway to legally market dietary supplements containing CBD derived from hemp by promulgating regulations under the FDC Act, stating that hemp-derived CBD is lawful. Rather than going through the time-consuming process of notice and comment rulemaking, CHPA requests that FDA, under section 553(b) of the Administrative Procedure Act, proceed by issuing an interim final rule.  Alternatively, if FDA were to decide to go through notice and comment rule making, CHPA asks that, in the interim, FDA issue guidance on enforcement discretion for companies that act consistent with the proposed rule.
  2. For CBD drugs, continue to enforce the requirements and protections under the new drug application process.
  3. Increase enforcement actions against “unscrupulous manufacturers” of CBD-containing products that market their product with illegal drug claims or otherwise fail to comply with the FDC Act.
  4. Monitor safety issues, if any, concerning CBD-containing products.

FDA has expressed concern about lack of information on the safety of CBD products and is hesitant to issue a rule stating that CBD may legally be used in supplements without predetermining the safety of CBD for such use.  Rather than putting this burden on FDA, CHPA proposes that FDA’s regulation specify that manufacturers of CBD-containing products must submit new dietary ingredient (NDI) notifications for CBD; CHPA asserts that “NDI notifications would provide FDA with much-needed data on CBD since they must include evidence establishing a reasonable expectation of safety when used under the conditions recommended or suggested in the product’s labeling.”

On November 25, 2019, FDA announced that it had issued another 15 Warning Letters to companies marketing CBD containing supplements or foods.  As before, the Warning Letters targeted companies that market CBD containing foods or dietary supplements with disease claims.  FDA also revised its consumer update outlining specific potential risks associated with CBD consumption.

We will continue to monitor CBD developments.

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Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval Promotion

Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval Promotion

By Deborah L. Livornese & Dara Katcher Levy

Just as many object to holiday music in November, the Office of Prescription Drug Promotion (“OPDP”) objected in an untitled letter issued earlier this month to claims made for an investigational drug.  The statements (since removed) appeared on a company website about an investigational drug for the treatment of brain cancer.

In the untitled letter (OPDP’s sixth this year, and eighth enforcement letter overall in 2019), OPDP provided the following examples of statements it characterized as promoting the drug as safe and effective:

  • [the drug] “has cured a rare form of brain cancer”
  • “Delivering human antibodies for the treatment of cancer”
  • “After 5 years, patients treated with [the drug] have an overall survival rate of 25-30%, compared to 3% standard therapy, demonstrating antibodies are safe and effective.”

In addition to objecting to specific claims about the investigational drug, OPDP noted that the website did not “include information to clearly indicate that [the drug] is an investigational new drug that has not been approved for commercial distribution in the United States.”   OPDP also stated that these claims were “especially troubling” because brain cancer is associated with a poor prognosis.  While we do not know how or why this particular website came under scrutiny, this language, along with recent pre-approval promotion enforcement letters, raise the question of whether the individual statements would have drawn an untitled letter if the website had included other language making clear that the drug was investigational and not yet approved, or if it had been for an investigational drug being studied for the treatment of a less serious disease with other approved effective treatments.

OPDP’s focus on pre-approval promotion has not appeared to shift over the past several years.  As we have previously noted (here), FDA may feel it is on safer ground given that its First Amendment case losses have related to information disseminated about marketed products – not wholly investigational products.

This is the second pre-approval promotion letter OPDP has issued this year. The earlier letter concerned an imaging agent for recurrent prostate cancer.  In 2018, OPDP issued one letter about pre-approval promotion (out of a total of seven letters for 2018) for an investigational treatment for AML in which it noted, similar to its most recent letter, that the claims were especially concerning given the seriousness of the disease and the relatively few treatment options.  It may be that OPDP’s pre-approval promotion surveillance focuses on drugs for cancer and other very serious diseases with few available treatment options as this may be an area of greater risk of public harm.  In any event, despite an overall drop in total annual letters since 2013, pre-approval promotion appears to remain an area in which OPDP enforcement is active.

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Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine

Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine

By Sarah Wicks & James E. Valentine & Frank J. Sasinowski

On November 13, 2019, the National Academies of Sciences, Engineering, and Medicine (NASEM) Forum on Regenerative Medicine hosted a workshop on Exploring Novel Clinical Trial Designs for Gene-Based Therapies. The Forum was tasked with exploring the design complexities and ethical issues associated with gene- and gene-editing-based therapies such as optimal dosage, delivering the product effectively and successfully recruiting patients to what may be “single chance” trials. Co-chaired by FDA’s Celia Witten, Deputy Director of the Center for Biologics Evaluation and Research (CBER), with a broad array of stakeholder participants, the workshop united the voices and perspectives of academic and industry researchers, regulatory officials, clinicians, bioethicists, and patients and patient advocacy groups. This blog post summarizes some of the key challenges identified during the workshop related to designing and conducting clinical trials for gene therapies, and some of the emerging practices shared to help overcome these challenges as we work together to bring more promising therapies to patients.

Challenge 1: Collecting High-Quality Natural History Data

Recently, there has been a great deal of emphasis on the importance of natural history studies, particularly for rare genetic diseases where little is understood about the progression of disease and response to available treatment (see previous coverage of FDA’s Rare Disease Natural History Studies Guidance here). Natural history studies are not only a tool to describe the disease (e.g., to inform development of endpoints) but can also be valuable as external controls (i.e., historical control and patient-as-their-own control). However, the rare or ultra-rare nature of many genetic diseases often makes it difficult to obtain robust natural history data.

But some natural history data is better than none, as one sponsor for a gene therapy for retinal diseases described. Even with a retrospective chart review of approximately 70 individuals, the sponsor was able to describe progression of disease. Another gene therapy sponsor for spinal muscular atrophy described that robustness can come from a mix of natural history data, such as prospective data, retrospective data, and lead-in cohorts. Dr. Witten summarized that natural history datasets can be made more robust with frequent visits, standardized measures, and an effort to collect high-quality patient-level data.  She also noted the importance of identifying the genetic diagnosis in patients, which could help with understanding genotype-phenotype relationships, in order to select clinical trial populations.

Challenge 2: Approaching Patient Concerns through Community, Informed Consent, and Partnership

We know that there is a high tolerance for risk in rare, progressive diseases with no approved therapies. However, patient advocates from Parent Project Muscular Dystrophy and the Friederichs’s Ataxia Research Alliance, among others, explained that there are unique patient concerns when considering whether to participate in a gene therapy trial:

  • Because patients receive only a single dose, how do we know the first dose is therapeutic?
  • Is it worth it to participate given that participation will exclude you from clinical trials for other investigational therapies?
  • Will affected siblings be able to gain access?

Given these unique concerns, how do we set expectations and discuss this with patients, particularly with pediatric populations?

While this is no easy question, Courtney Fitzhugh from the National Heart, Lung, and Blood Institute (NHLBI) at NIH, who is investigating a gene therapy for Sickle Cell Disease (SCD), described 3 factors that she found to influence patients when considering joining a clinical trial: family, faith and other patients. By conducting a survey, Dr. Fitzhugh learned that whether a patient has family that are providing moral support, a strong spiritual belief and community, and has talked with other patients who have participated in clinical trials greatly influences a patient’s decision to enroll in a study. John Tisdale, who is also working at NHLBI with Dr. Fitzhugh on SCD, discussed how sponsors of gene therapies know that the first dose is therapeutic. He described the typical trajectory of first studying investigational therapies in cell culture, then progressing to small and large animal models before ultimately moving into first-in-human trials. Dr. Tisdale emphasized the importance of selecting large animal models that are biologically relevant so that therapeutic doses observed in the large animal model are more predictive of therapeutic dose in the first trial patients. Dr. Witten summarized that patients and families should be partners in the R&D process, and that there is an opportunity to improve the informed consent process for gene therapy trials to help answer these unique patient questions and concerns.

Challenge 3: Inclusion of Pediatric Populations in Gene Therapy Trials

For many genetic diseases, the earlier intervention is received, the better the eventual outcome, which increases the interest of including pediatric populations from the very outset of intervention development. Newborn screening is an important tool to help identify infants with these conditions, and when done at a population-level, it promotes fair access to cutting-edge technologies in clinical trials.

But to include children in interventional trials, when there is more than minimal risk, there must be a prospect of direct clinical benefit and the risk-benefit must be at least as favorable over other available therapies, which typically are nonexistent. Additionally, sponsors need to be specific across the type of pediatric population they wish to study (i.e., newborn, infant, child, adolescent) because there may be unique differences between these subgroups, and compared to adults, that leads to different trial designs and outcome measures.

Challenge 4: Developing Efficacy Endpoints for Gene Therapy Trials

For rare genetic disorders for which there are no other treatments available, a novel endpoint usually must be established. Larissa Lapteva, Associate Director of the Division of Clinical Evaluation, Pharmacology, and Toxicology (DCEPT) within CBER’s Office of Tissues and Advanced Therapies (OTAT), described three points to consider when developing efficacy endpoints for gene therapy trials:

  1. Consider the long-term or potentially irreversible effects of gene-therapy treatment; Dr. Lapteva noted that there is little room for uncertainty about endpoint performance and sponsors are therefore required to increase vigilance in validity and accuracy of endpoint measurement.
  1. Mechanistically agnostic endpoints that are reflective of common pathogenetic pathways may not be sufficiently sensitive in gene-therapy trials;

Sponsors need to consider that the increased availability of genetic screening, early diagnosis, and advanced lab testing has shifted the demand toward surrogate and clinical endpoints that are reflective of early disease manifestations. Additionally, the identification of genetic defects associated with non-well-characterized phenotypes has increased the need for novel clinical endpoints.

  1. Opportunity to identify and validate surrogate endpoints along the pathway of gene transcription, transgene protein synthesis and level, functional activity and clearance.

Following Dr. Lapteva’s remarks, an investigator studying a gene-therapy for SCD described how pain as a primary outcome is overly subjective, making it difficult to identify the unique cause of the pain and to differentiate chronic versus acute pain. She also noted that biologic endpoints in SCD, while each with limitations, are based primarily on predictive value and are only associated with disease severity, not disease modifiers. Meanwhile, the sponsor of a now-approved gene therapy for an inherited retinal dystrophy provided a case study detailing how the lack of a clinically meaningful endpoint for rod vision led the sponsor to develop a novel functional vision endpoint that was the primary basis for approval (see our previous coverage of this gene therapy’s development and endpoint here).

Challenge 5: Considerations for Long-Term Follow-Up (LTFU)

Tejashri Purohit-Sheth, Director of DCEPT, described the importance of LTFU and considerations for sponsors to manage such follow-up. LTFU is needed because gene-therapy products are designed to achieve prolonged or permanent therapeutic effects and such long-term exposure may result in undesirable or unpredictable adverse outcomes that may occur past the period of monitoring. Sponsors should take into account multiple factors when considering their risk-assessment, including product characteristics, the target cell/tissue/organ, and preclinical and clinical information. Characteristics that increase risk include integration activity of the gene-therapy product, genome editing activity, prolonged expression of the transgene, potential for latency, and establishment of persistent infections. For more information on LTFU, we direct you to FDA’s Draft Guidance on LFTU After Administration of Human Gene Therapy Products here.

Dr. Witten summarized that patient registries, mobile health applications, and other remote tools may help with the collection of patient-reported outcomes in the subsequent 10 years of post-marketing follow-up when subjects should be contacted a minimum of once a year.

In addition to those provided in-text, our readers can find some of our additional coverage of gene therapy regulation:

  • Gene Therapy and Orphan Drug “Sameness” here
  • FDA’s Comprehensive Policy Framework for Regenerative Medicines here
  • FDA “State of Cell and Gene Therapy Statement” here
  • Historic Approval of First Systemically-Administered Gene Therapy here


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FDA Issues Draft Guidance Reflecting Expansion of PMR Authority

FDA Issues Draft Guidance Reflecting Expansion of PMR Authority

By McKenzie E. Cato & Josephine M. Torrente

In October, FDA issued a draft guidance titled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act,” which will replace a similar April 2011 draft guidance once finalized.  This new draft guidance reflects a significant expansion of FDA’s authority to require postmarketing studies.  FDA is now permitted to establish postmarket requirements (PMRs) to study efficacy in addition to safety.

This expansion of FDA’s PMR authority is the result of section 3041 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).  While the SUPPORT Act is generally focused on opioid drugs and treatments for opioid addiction, section 3041 on PMRs is not limited to any particular drug class.

Section 3041 of the SUPPORT Act revised the definition of “adverse drug experience” at section 505-1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FDC Act) to include “reduced effectiveness under the conditions of use prescribed in the labeling of [a] drug.”  The purpose of a PMR is to assess a known serious risk, assess signals of a serious risk, or identify an unexpected serious risk when data indicate the potential for a serious risk.  Id. § 505(o)(3)(C).  A “serious risk” is a risk of a “serious adverse drug experience.”  Id. § 505-1(b)(5).  Because adverse drug experience now includes reduced effectiveness, FDA can issue a PMR for an efficacy study.

After a drug is approved, FDA can require an additional study on the basis of “new safety information.”  Id. § 505(o)(3)(C).  “New safety information” includes information derived from adverse events.  Thus, if FDA finds that there is reduced effectiveness under the conditions of use prescribed in the labeling once a drug is already on the market, it can require a new efficacy study even if that study was not listed as a PMR at the time of approval.

Notably, the SUPPORT Act also expanded FDA’s authority to require labeling changes under the safety labeling change notification process (id. § 505(o)(4)).  Now, FDA can require labeling changes due to new effectiveness information in addition to new safety information (e.g., if FDA determines that the results of an efficacy PMR warrant a change to the drug’s approved labeling).

The SUPPORT Act required FDA to issue guidance “regarding the circumstances under which [FDA] may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient” within one year of the date of enactment (Oct. 24, 2018).  This draft guidance was issued about one week before the one-year deadline.

The draft guidance clarifies how the SUPPORT Act’s amendment to FDA’s definition of “adverse drug experience” affects FDA’s PMR authority: “In some cases, when a serious risk relates to failure of expected pharmacological action, including reduced effectiveness, the trial might be designed with an efficacy endpoint, for example, to further assess whether a failure of expected pharmacological action, including reduced effectiveness, may result in a serious adverse drug experience.”

The draft guidance provides several examples of clinical trials intended to assess reduced effectiveness, including studies for:

  • Determining whether treatment duration of an antiviral drug should be extended;
  • Evaluating a newly identified drug-drug interaction that could reduce systemic exposure;
  • Evaluating a newly identified antibody response to a biologic; and
  • Evaluating a new signal that a subgroup of patients with a life-threatening cancer may not respond to an approved drug.

The draft guidance makes clear that FDA can order labeling changes due to the results of an effectiveness PMR.  The draft guidance states, regarding both safety and efficacy endpoints in PMRs: “FDA will review the data and/or information obtained under a PMR and assess its effect on the benefit-risk profile of the drug in the context of a serious risk being evaluated.  This may result, for example in labeling changes under section 505(o)(4) of the [FDC Act].”

These labeling changes could consist of additional warning statements, but they could also consist of significant changes to the indications for use.  For example, if an efficacy study found that a subgroup of patients (e.g., a gender, ethnicity, or age subgroup) demonstrates reduced effectiveness, FDA could require changes to a drug’s indications for use statement.

Comments on the draft guidance are due January 17, 2020.  However, this expansion of FDA’s PMR authority cannot be meaningfully changed through revisions to the guidance.  Because issuance of the draft guidance was mandated by Congress through the SUPPORT Act, any adjustment to FDA’s new authority to issue effectiveness PMRs will have to be addressed through a legislative fix.  It remains to be seen how this new authority will play out in practice, but industry groups may eventually be motivated to seek a legislative change.

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Teeth, They Must Be Very Much Worthwhile: GAO Report on REMS Abuses Notes Lack of Agency Enforcement

Teeth, They Must Be Very Much Worthwhile: GAO Report on REMS Abuses Notes Lack of Agency Enforcement

By Sara W. Koblitz

The Government Accountability Office released a new Report last week focusing on the oft-analyzed tactics used by some innovator or brand-name pharmaceutical manufacturers to keep generic versions of products off the market.  Like some facets of then-Commissioner Gottlieb’s Drug Competition Action Plan, the GAO Report focuses specifically on the use of REMS programs to prevent generic companies from obtaining samples.  While FDA and FTC have been working together to help make drug samples easier to obtain (as we at HPM can confirm from personal experience), the GAO Report found that drug companies and stakeholders are not sold on the effect of the agencies’ actions.  This is because the main tools used – letters from FDA, public shaming, FTC review, and waivers from shared REMS systems – lack teeth.  In such situations, there is very little that FDA can do, as it can’t compel reference product sponsors to make products available.  Only the FTC has the ability to take enforcement action for the anticompetitive behavior at issue, but thus far it hasn’t done so.  Therefore, reference product companies may have little incentive to curb these practices.

The need for this GAO Report arose from complains from generic companies that some reference product sponsors use the REMS process to hinder competition by delaying or preventing generic drugs from being developed or coming to market.  Two practices that FDA and FTC are particularly concerned about are the limiting of access to samples of reference standard products needed to show bioequivalence and delaying negotiations for shared REMS programs.  Reference product sponsors may limit access to samples of reference standard drugs both that are subject to REMS, by refusing distribution outside of that REMS, or that are not subject to REMS, by limiting the sale of their reference standard drugs only to certain pharmacies (like specialty pharmacies).  In practice, these activities can restrict all purchases of these products by generic companies who may need them as reference product samples.  Delayed REMS negotiations may occur where the reference product sponsor and the ANDA sponsors cannot come to an agreement on the system, which may delay the approval of an ANDA until such an agreement can be made.

While FDA and FTC have not done much in the way of enforcement, the Report focuses on four actions that FDA and FTC have taken to address these circumstances:

  • Draft guidance on Safety Determination Letter: In 2014, FDA issued a draft guidance explaining FDA’s ability to issue a “safety determination letter” to the reference drug company on behalf of the generic manufacturer, assuring the reference drug sponsor that this distribution would not constitute a REMS violation;
  • Public Website on Inquiries to FDA About Samples: In February 2019, FDA released a website posting information on inquiries made to FDA by generic companies unable to obtain reference standard samples in an effort to publicly shame innovator companies into providing samples to putative generic manufacturers;
  • FTC review: FTC reviewed the inquiries FDA received about samples and filed two amicus briefs related to drugs with REMS, but has not yet brought suit for violation of the Federal Trade Commission Act or the Sherman Act;
  • Shared REMS Waivers: FDA has issued waivers of the single shared REMS requirements, allowing generic drug companies to develop a separate REMS system including the same Elements to Assure Safe Use as the RLD.  In 2018, FDA published guidance describing the relevant considerations in its assessment of shared REMS waiver requests, including a comparison of the burdens and benefits of a single shared system and elements of the REMS protected by intellectual property considerations.

The GAO talked to four generic drug manufacturers and five reference standard product manufacturers to get their perspectives on FDA’s and FTC’s efforts to address these practices, in addition to reviewing comments submitted to the federal register with respect to these efforts.  True to form, the generic and reference product manufacturers had differing opinions on these efforts.  The generic companies, for example, found the safety determination letters not useful because they are not enforceable, while the reference product companies who could opine on the issue liked them and noted that they now require them before releasing samples.  The public shaming webpage was an all-around disappointment, as the generic companies got little out of it while some of the reference product companies were unaware of any sample inquiries prior to being included on the webpage.  The waivers also received mixed reviews due to FDA’s timeline for responding to waiver requests, as well as the burden imposed on health care professionals and patients in navigating several REMS systems.  Interestingly, the generic companies thought that the FTC’s amicus briefs were at least helpful, but none of the reference drug companies had any opinions at all on the FTC’s briefs.

The running theme throughout all of these efforts though is that FDA’s efforts are largely fruitless because the Agency cannot compel reference product sponsors to provide samples or to negotiate.  As many lawyers can attest, sometimes a strongly-worded letter just isn’t enough.  And neither is public shaming or a waiver process that ends up taking multiple years.  The FTC is the only one here with any enforcement power, but we’re still waiting to see whether it chooses to exercise it.  It’s taken years of complaining over Citizen Petitions for the FTC to take any action (see our extensive blogging on this case here and here to start), so maybe generic companies just need to bide their time until FTC makes examples out of a few bad actors.  But like with many complaints of anticompetitive conduct, it may to take enforcement action – and use of those regulator teeth – to really get industry attention.

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U.S. Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims

U.S. Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims

By Riëtte van Laack

On October 23, 2019, the U.S. Cattlemen Association (USCA) petitioned USDA regarding Made in USA and Product of USA and similar claims on beef.

USCA explains that it is concerned that voluntary “Made in USA” labeling for beef products, without a clear definition of what constitutes “Made in USA” or “Product of USA” or other such similar designations, will lead to consumer confusion if meat from animals that are not born, raised and harvested in the United States is marked with this type of designation.  Therefore, USCA contends that voluntary labels indicating “Made in USA,” or similar claims should be limited to beef from cattle born, raised, and harvested in the United States.

USCA asks that USDA revise its policy and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have been born, raised, and harvested in the United States.

USCA supported the mandatory country of origin labeling (COOL) requirements for livestock.  The COOL law and implementing regulation mandated that meat be labeled with a statement as to where the animals were born, raised, and harvested.  The WTO ruled against the mandatory COOL requirements and the regulations and the law mandating COOL for beef and pork were repealed.  The current Petition does not request that USDA reinstate mandatory COOL.  Instead, it requests that USDA set a standard for voluntary “Made in the USA” and similar claims.

As readers of this blog know, last year, the Organization for Competitive Markets & American Grassfed Association (OCM) petitioned USDA over the same claim.  The USCA Petition does not refer to the 2018 OCM petition, nor does it address why the standard should be USCA’s proposed standard (which specifically requires that the animals are born and raised as well as “harvested” in this country) rather than the standard proposed by OCM, which does not require that animals are born in the United States.

FSIS opened a docket on where comments can be submitted.

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