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 a New Hampshire personal injury 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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FDA Wants to Know about Sugars That Do Not Act Like “Traditional Sugars”

FDA Wants to Know about Sugars That Do Not Act Like “Traditional Sugars”

By Riëtte van Laack & Ricardo Carvajal

As we previously reported, FDA was petitioned to exempt allulose, a monosaccharide, from being included as a carbohydrate, sugar, and added sugar in the Nutrition Facts box, as well as recognize that the number of calories for this monosaccharide is less than the 4 calories per gram used for traditional sugars.  In response, FDA issued a draft guidance, which was finalized on  Oct. 16.  The final guidance informs manufacturers that the Agency plans to exercise enforcement discretion regarding the requirement to include allulose in the amount of total sugars and added sugars, and for the use of 0.4 calories per gram of allulose when calculating calories for purposes of nutrition labeling.  However, allulose must be included in the amount of total carbohydrates.

On the same day, FDA announced that it would be issuing a request for information regarding the nutrition labeling of “sugars” (i.e., mono- and di-saccharides) that are metabolized differently than “traditional sugars,” and thus do not provide the same amount of calories per gram (traditional sugars provide 4 cal/g), do not cause an increase in blood glucose and insulin upon consumption, and are not associated with tooth decay.  FDA has received requests from industry to treat these “non-traditional” sugars, such as allulose, D-tagatose and isomaltulose differently from “traditional sugars” for purposes of nutrition labeling.  As mentioned above, FDA has decided to exercise enforcement discretion for allulose, and a petition to do the same for D-tagatose is pending.

FDA asks for information about several topics, including:

  1. General information about sugars that are metabolized differently than traditional sugars.
  2. Should the non-traditional sugars be included in total sugars and added sugars for purposes of nutrition labeling and, if yes, how should the amount be corrected for the difference in metabolic effects?
  3. Should FDA adjust the % Daily Value for “added sugars,” using the caloric value of the non-traditional sugar?
  4. Should FDA allow inclusion of the non-traditional sugars in the Nutrition Facts box similar to sugar alcohols?

The answers to these questions could carry significant implications for nutrition labeling of foods that contain non-traditional sugars, and thereby affect the formulation of such foods.

Comments may be submitted until Dec. 18, 2020.

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The Potential Life Sciences Implications of the Election

The Potential Life Sciences Implications of the Election

The medtech industry has significantly changed during the Trump administration’s last four years. FDA processes are streamlined, the medical device excise tax repealed, and the Senate is in the process of confirming a third Supreme Court nominee. The industry also rapidly responded to the unprecedented COVID-19 health crisis.

What changes are on the horizon for the medtech industry after the November 3rd election, whether with another Trump administration or a Biden administration?  On Wednesday, October 28th, 2020, from 2:00 – 3:00 p.m. ET, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro will present at a webinar, titled “The Potential Life Sciences Implications of the Election.”  Mr. Shapiro will cover the upcoming U.S. presidential election and its possible ramifications for the medical device industry.

You can register for this free webinar here.

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Join Top Genomics and Regulatory Experts to Analyze the Law Governing Genomics Research, Data, and Clinical Care

Join Top Genomics and Regulatory Experts to Analyze the Law Governing Genomics Research, Data, and Clinical Care

Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy lag behind science, and the law governing genomics remains unclear – which means the time is ripe for analysis and thoughtful recommendations.

On Wednesday, December 2, top experts from Harvard Medical School, Columbia University, Vanderbilt University, the University of Minnesota, and other leading genomics and regulatory institutions will convene online to tackle these issues. Hyman, Phelps & McNamara PC is co-hosting this conference on “LawSeqSM: Facing the Legal Barriers to Genomic Research & Precision Medicine.” Join us to discuss pressing legal and policy issues in genomic research and clinical care; FDA regulation of genomic devices, software, and algorithms; and uses of genomic data. Speakers include Gail Javitt, JD, MPH, from Hyman Phelps; Mark Barnes, JD, LLM, from Ropes & Gray; Alberto Gutierrez, PhD, and Elizabeth Mansfield, PhD, both formerly at FDA; Wendy Chung, MD, PhD, from Columbia University; Barbara Bierer, MD, from Harvard Medical School; and Ellen Wright Clayton, MD, JD, from Vanderbilt University. An agenda and more information is available here. This free conference will offer general CLE credits for New York, California, Illinois, and Minnesota.

Register now to attend. The event is presented by the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota in collaboration with Ropes & Gray, LLP, Hyman, Phelps & McNamara PC, and Vanderbilt University Medical Center. This conference grows out of an NIH-funded grant on “LawSeqSM: Building a Sound Legal Foundation for Translating Genomics into Clinical Application” based at the University of Minnesota and Vanderbilt University Medical Center, in collaboration with a Working Group of national experts. For more information on “LawSeqSM,” visit here.

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Hemp By Any Other Name…

Hemp By Any Other Name…

By Sara W. Koblitz & Karla L. Palmer

Back on August 20, 2020, the Drug Enforcement Administration (“DEA”) issued an Interim Final Rule (“IFR”) purporting to “clarify” certain provisions of the Agriculture Improvement Act of 2018 (“AIA”).  As we explained back when Congress passed the AIA in December 2018, the AIA upended the DEA’s regulation of hemp-derived products.  Historically, the DEA had interpreted the term “marihuana,” regulated as a schedule I drug under the Controlled Substances Act (“CSA”), to include hemp and hemp-derived products, but the AIA explicitly removed hemp from the “marihuana” CSA definition.  As a result, Congress implicitly transferred regulatory authority of hemp as defined in the AIA from DEA to the U.S. Department of Agriculture (“USDA”).  Further, the AIA added a definition of the term “hemp” to the CSA to make explicitly clear that DEA’s regulatory authority does not extend to hemp, which is now defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [“THC”] concentration of not more than 0.3 percent on a dry weight basis.”  Accordingly, any cannabis or cannabis-derived product that includes THC in a concentration above 0.3 percent on a dry weight basis, as well as THC itself, is not hemp and remains a schedule I controlled substances.  The intent of the AIA’s removal of hemp from DEA control was to facilitate the growth of emerging hemp industry.

But DEA apparently had other ideas.  In the IFR, DEA explained that the definition of hemp “does not automatically exempt any product derived from a hemp plant, regardless of the Δ9-THC content of the derivative,” and that “a cannabis derivative, extract, or product that exceeds the 0.3% Δ9-THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less Δ9-THC on a dry weight basis.”  This language has been interpreted to suggest that DEA believes that any hemp extract that exceeds the 0.3% limit—even if only as intermediate materials or byproducts during processing—are controlled substances subject to DEA regulation, effectively rendering hemp production where THC exceeds 0.3 percent subject to the CSA’s rigorous schedule I requirements.  Further, as set forth for the first time in the IFR, DEA excluded all synthetically-derived tetrahydrocannabinols from the hemp definition, noting that “[f]or synthetically derived tetrahydrocannabinols, the concentration of Δ9-THC is not a determining factor in whether the material is a controlled substance.” Thus, all synthetic forms of cannabis and its derivatives, regardless of the Δ9-THC content, are still subject to DEA control.

Importantly, DEA enacted the IFR without undertaking notice and comment as required under the Administrative Procedure Act (“APA”).  Specifically, the DEA framed the IFR as a clarification that “does no more than incorporate the statutory amendments into DEA’s regulations,” and a mere restatement of the AIA, subjecting it to the “good cause” exemption from rulemaking requirements under the APA.  The IFR explains that “DEA has no discretion with respect to these amendments,” particularly because the “statutory changes at issue have already been in effect since” passage of the AIA.

DEA’s position concerning synthetically derived CBD products with a THC content of less than 0.3 percent was an unwelcome “surprise” (putting it kindly) to several industry participants.  Notably, the IFR was the first time that DEA had publicly stated since the enactment of the AIA that synthetically derived tetrahydrocannabinols remain schedule I drugs.  Privately, in letters to industry, DEA had taken exactly the opposite position.  DEA expressly stated in 2019 letters to industry that, after a review of the AIA, it determined that synthetic cannabinols (CBD) containing less than 0.3% Δ9-THC met the definition of “hemp” and therefore were no longer scheduled drugs under the CSA.  DEA’s 2019 position concerning synthetics made sense for many reasons, including because the AIA’s definition applies to cannabis derivatives, “whether growing or not,” which can be interpreted to include synthetic cannabis.  And, CBD with less than 0.3 percent THC, whether plant-based or synthetic, has virtually the same chemical structure and psychoactive effect.

Regardless of whether DEA’s 2019 interpretation treating synthetics and plant-derived products the same, DEA’s August 2020 IFR makes no mention whatsoever of its “change in position,” but instead, ignoring its own previous interpretation and industry’s reliance interests, DEA remarkably insists that the IFR merely implements statutory changes that “have already been in effect since” December 2018.  Really?

The IFR has been the subject of over 3,000 comments, and, less than a month after publication, DEA was sued in the D.C. Circuit, and a subsequent lawsuit in the District Court followed last week.  The D.C. Circuit Petition for Review, filed by the Hemp Industries Association and RE Botanicals Inc., is a barebones petition alleging that DEA failed to comply with the procedures required by law in the CSA and APA, that the IFR exceeded DEA authority, and that the IFR is arbitrary and capricious due to its inconsistency with the AIA.  The District Court lawsuit, also brought by the Hemp Industries Association and RE Botanicals Inc., contains a detailed explanation of the hemp production process and argues that hemp intermediates or byproducts that may exceed 0.3% Δ9-THC during production but ultimately contain less than 0.3% Δ9-THC after completion of the manufacturing process, should not be schedule I drug products.  Though the IFR is not expressly clear that intermediates or byproducts will be regulated as schedule I drugs (requiring adherence to onerous schedule I regulatory requirements), it is clear that the hemp industry sees the disconcerting writing on the wall.  According to the plaintiffs, DEA’s interpretation subjecting the hemp production process when hemp intermediates or byproducts exceed 0.3% Δ9-THC during production would effectively subject almost all hemp to schedule I controls.  Based on this reading, the District Court complaint—relying on congressional intent and plain language of the statute—requests declaratory and injunctive relief and asks the Court to make a judicial determination that the definition of hemp includes intermediates or byproducts that exceed 0.3% Δ9-THC in midst of the production process and that those intermediates are not controlled substances, that DEA lacks any independent authority to regulate any aspect of hemp production, and that DEA is enjoined from enforcing the CSA as to intermediates.

Some of the comments on the IFR raise points related to the interpretation of “synthetically-derived tetrahydrocannabinols.”  Though the D.C. Circuit Petition for Review takes issue with the “good cause” exception absolving DEA from adhering to the APA’s notice and comment rulemaking requirements, the issue is not raised in the District Court lawsuit.  As a result, it would not be surprising if another industry participant also sued DEA in a district court over DEA’s application of the APA’s good cause exception as applied to synthetic CBD.

Based on some of the history provided in the District Court complaint, as well as the available comments, DEA’s exercise of statutory authority here is pretty expansive—and arguably well beyond that intended by Congress.  Congress transferred regulatory authority over hemp to USDA, which raises an argument that Congress intended that USDA – rather than DEA — interpret the statutory definition of hemp.  Further, with the growing importance of the hemp marketplace, it would not be surprising to see a slew of litigation challenging DEA’s authority to interpret the definition of hemp, the DEA’s actual interpretation of hemp, and the rulemaking process DEA used to interpret hemp.  After all (with apologies to the Bard), that which we call hemp — specifically synthetic – by any other name would not smell as sweet, at least according to DEA.

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Lemonade from Lemons: Fairness in FDA Enforcement Actions

Lemonade from Lemons: Fairness in FDA Enforcement Actions

By Anne K. Walsh & John R. Fleder & Robert A. Dormer

Although it is difficult to glean much positive during these COVID-times, particularly if you are (or could be) the subject of a government enforcement action, this post attempts to provide a possible silver lining.  As part of an effort to support economic recovery during this public health emergency, on May 19, 2020, President Trump issued Executive Order 13924 to set forth what he asserted were ten principles of fairness that federal agencies “shall consider” in administrative enforcement and adjudication actions.  The Office of Management and Budget recently expanded on these principles in a memorandum detailing “best practices” for federal agencies to follow in implementing rules under the Executive Order, and stating that it expects federal agencies to issue any final rules under the Executive Order by November 26, 2020, absent a waiver.   See M-20-31, Implementation of Section 6 of Executive Order 13924 (Aug. 31, 2020).  There is no doubt that the Executive Order and the OMB memorandum apply to all federal agencies, including FDA, FTC, DEA, CPSC, and USDA.   In this post, we will focus on one of those agencies, FDA.

So far, we have not seen any rulemaking from FDA that adopts these principles or best practices into FDA procedures.  Because the OMB deadline falls after the elections, it will be interesting whether FDA will follow these recommendations should there be a change in Administration.   But if FDA adopts these recommendations, it would go a long way to making FDA more transparent, fair, and accountable when opening and investigating conduct by FDA-regulated industry.

The Executive Order lists the following principles of fairness:

(a) The Government should bear the burden of proving an alleged violation of law; the subject of enforcement should not bear the burden of proving compliance.

(b) Administrative enforcement should be prompt and fair.

(c) Administrative adjudicators should be independent of enforcement staff.

(d) Consistent with any executive branch confidentiality interests, the Government should provide favorable relevant evidence in possession of the agency to the subject of an administrative enforcement action.

(e) All rules of evidence and procedure should be public, clear, and effective.

(f) Penalties should be proportionate, transparent, and imposed in adherence to consistent standards and only as authorized by law.

(g) Administrative enforcement should be free of improper Government coercion.

(h) Liability should be imposed only for violations of statutes or duly issued regulations, after notice and an opportunity to respond.

(i) Administrative enforcement should be free of unfair surprise.

(j) Agencies must be accountable for their administrative enforcement decisions.

While the principles themselves are straightforward, the OMB memorandum suggests certain “best practices” that are not consistent with some of FDA’s established practices.  For example, when negotiating the terms of a consent decree, the question of whether to include a sunset provision is often a hot topic for discussion, with FDA at times arguing against the inclusion of any expiration date, or proposing the same time period be used in all consent decrees without regard to the violation at issue or the public health impact.  The OMB memorandum recommends that agencies “adopt expiration dates and/or termination criteria for consent orders, consent decrees, and settlements that are proportionate to the violation of the law that is being remedied.  Decade(s)-long settlement terms that are disproportionate to the violation(s) of law should be strongly disfavored absent a clear and convincing need for time to implement a remedy . . . .”  OMB Memo, subsection (f).

OMB also expects that federal agencies will “publish a rule of agency procedure governing civil administrative inspections,” in subsection (b) of the OMB memo.  This mandate simply reiterates a requirement from Executive Order 13892, which was issued a year ago:

Within 120 days of the date of this order, each agency that conducts civil administrative inspections shall publish a rule of agency procedure governing such inspections, if such a rule does not already exist. Once published, an agency must conduct inspections of regulated parties in compliance with the rule.

As it stands now, the principles governing FDA inspections are set forth in a hodgepodge of reference documents (e.g., Compliance Program Guidance Manual, Compliance Policy Guides, Regulatory Procedures Manual, Investigations Operations Manual, and Inspection Guides), none of which has been subject to rulemaking.

Another area that, if adopted, would be a sea-change from FDA’s current practice is the recommendation that federal agencies provide regulated industry with notice about the closure of an investigation:  “If a party has been informed by an agency that it is under investigation, the agency should inform the party when the investigation is closed and, when the agency has made no finding of violation, so state.”  This courtesy notification will obviate the current dilemma a target faces when in limbo, not knowing whether the government still is investigating but too nervous to “poke the bear” to ask directly.

There are several other “best practices” that would level the playing field for subjects of an investigation, like requiring the government to provide favorable evidence to the subject of an enforcement action, or to apply enforcement discretion if the regulated party attempted in good faith to comply with the law.   As noted, the November 26, 2020 deadline presents an interesting scenario for us to watch; it is extremely unlikely that in one month FDA can issue final rules that have not yet been proposed, and given the drastic changes that are recommended, we expect there is tremendous internal debate on making any proposals before the elections.  But if FDA does, in fact, issue new (or revised) procedures in accordance with these recommended best practices, there may be some lemonade squeezed from these COVID-lemons.

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FDA (Again) Proposes A Rule to Clarify The “Intended Use” Regulation

FDA (Again) Proposes A Rule to Clarify The “Intended Use” Regulation

By Jeffrey K. Shapiro

A determination of “intended use” is fundamental to the U.S. Food and Drug Administration’s (FDA) regulation of drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).  It is a primary basis for determining if an article is regulated by FDA, and if so, what regulatory requirements apply.

FDA has now proposed to amend the regulation “to provide direction and clarity to regulated industry and other stakeholders.”  85 FR  59,718, 59,718 (Sept. 23, 2020).  This proposal modifies a 2015 proposal to amend the regulation, which ultimately was not finalized.  The saga of the 2015 proposal and the events leading to this new one are set forth in the preamble to the new proposal.  We blogged on the prior proposal here and here.   Our own proposal for reforming the regulation is here.  In today’s post, we will provide some initial thoughts on the new proposed rule.

Current Regulation

In the “intended use” regulations, FDA defines the term and describes the evidentiary basis for determining the intended use of articles that are being marketed.  There is one regulation for devices and another for drugs, but they are in substance the same (21 C.F.R. §§ 201.128, 801.4).

For reference, the current regulation (device version) reads as follows:

The words intended uses or words of similar import . . . refer to the objective intent of the persons legally responsible for the labeling of devices   The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.  This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.  It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.  The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.  If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.  But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

Proposed Amendment

In FDA’s proposal, the agency would entirely delete the last sentence of the regulation:  “But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.”  This deletion was, in fact, the heart of FDA’s original proposal back in 2015.

The sentence to be deleted has always been problematic.  As we stated five years ago:

This ‘knowledge’ provision for many years has hung like the Sword of Damocles over the heads of manufacturers who have any knowledge of off‑label uses of their products.  The possibility was always present that FDA could deem such knowledge to create a new intended use.  If so, a manufacturer could find itself in trouble for failing to provide adequate directions for this imputed intended use.  FDA also could deem the intended use an unapproved use outside the scope of the existing clearance or approval, opening the manufacturer up to criminal and civil liability for past sales and the burden of developing a new marketing application to bring the imputed use on‑label.

This change is, therefore, a welcome one.  It would have been a good stopping point.  But FDA’s proposed amendment has two substantive additions to the intended use regulation as well.

Addition #1.  In the second sentence, FDA would add that objective intent can be inferred from “the design or composition” of the article.  The sentence currently states:  “The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article.”  The revised sentence would include the phrase shown in italics:  “The intent is determined by such persons’ expressions, the design or composition of the article, or may be shown by the circumstances surrounding the distribution of the article.”

This change is a significant departure from the historical focus of the intended use regulation on communicationsThe regulation has never before expressly specified that the physical attributes of an article may underlie an intended use determination.  Significantly, the new language does not say that the design or composition will exclusively determine intended use.  Nor does it say that the design or composition overrides a firm’s labeling or advertising in determining intended use.  If the regulation were applied in that way, it could potentially be contrary to law.

For example, in Section 513(i)(1)(E) of the FDCA, FDA is required to limit the determination of intended use in premarket review to the proposed labeling.  If FDA believes based upon a device’s design that an off-label is possible and could cause harm, it may require certain cautionary labeling statements.  The agency may not require that the company obtain clearance or approval of the off‑label use.

Given the proposed new language, would FDA be authorized to infer solely from the design of the device once it is on the market that an off‑label use is intended?  It seems likely that this application of the proposed new language would contradict Section 513(i)(1)(E), at least in the absence of communications from the firm promoting the off‑label intended use.

At a minimum, the proposed rule should be amended to clarify that it does not override Section 513(i)(1)(E).  (Even if it is not amended, in a clash between the statute and the regulation, the former must prevail.)  More fundamentally, the proposed rule should be amended to clarify that, with respect to drugs/devices that have a clearance or approval, only post‑market alterations to the design or composition may be considering whether the company has created an unapproved new intended use.  If the design or composition has been cleared or approved after FDA’s premarket review, then the proposed rule should not authorize FDA to invoke the same design or composition as evidence of an unapproved new intended use.  The current proposed language improperly authorizes FDA to do so.

Addition #2.  FDA also proposes to add a proviso.  The regulation currently states:  “It [objective intent] may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.”  The amendment would add:  “provided, however, that a firm would not be regarded as intending an unapproved new use for an approved or cleared device based solely on that firm’s knowledge that such device was being prescribed or used by health care providers for such use.”

A couple of comments on the proviso.

First, the proviso should be extended to devices that are 510(k)‑exempt.  There is no reason not to include them.

Second, this language moves the intended use regulation in the direction of recognizing the important distinction between (i) articles without any clearance or approval from FDA versus (ii) articles that have a clearance or approval from FDA but also may be put to additional unapproved uses in the practice of medicine.  Under the current regulation as now in effect, in both scenarios (i) and (ii), FDA may consider the offeror’s knowledge of the use to which the article in the determination of intended use.  In contrast, with the amended language, in scenario (ii), FDA could not rely “solely” on the seller’s knowledge of the off‑label use to determine intended use.

As argued here, FDA should be much more constrained in applying the intended use regulation in scenario (ii) (where an article has at least one cleared or approved use) versus scenario (i) (where an article has not been cleared or approved for any use).  This proviso is a small step toward at least acknowledging the distinction.  That is the silver lining.

At the same time, unfortunately, FDA’s proposed proviso is limited by “solely.”  This word implies that knowledge of off‑label use could be an element in determining intended use in scenario (ii).  That implication undermines the proposed deletion of the “knowledge” sentence and seemingly brings it back into play.  It also creates obvious lack of clarity and open‑endedness about the role of knowledge of off-label use in this determination.  This potential for greater uncertainty is quite ironic considering the amendment is touted as a “clarification” of the intended use regulation.  The word “solely” should be struck from the proposal.

Preamble

The preamble to the proposed rule (85 FR 59,718) has a summary of how FDA and the courts have historically determined intended use.  Id. at 59,721‑724.  It also has a number of examples of how FDA would apply the rule with the proposed amendments.  Id. at 59,724-726.  Finally, FDA argues that the regulation, both currently and once the proposed revisions are implemented, is consistent with the First Amendment.  Id. at 59722.

There is little in the preamble that breaks new ground.  It is an interesting question whether the courts should give deference to FDA’s legal arguments and examples of how the regulation might be applied, simply because they have now been incorporated into the preamble.  Typically, a preamble is entitled to weight or deference from a court in explaining or interpreting ambiguous language in a regulation.  But this regulation is not so much ambiguous as vague and open‑ended.  It gives some notice of how FDA may evaluate statutory intended use, but it mainly notifies firms that almost any evidence may be used.

As FDA seems to acknowledge (id. at 59,723), the agency must still justify its position in any specific case.  In this context, a legal justification or an example of how the regulation might be applied does not gain persuasiveness or authority just because it was anticipated in the preamble.  The chief value of the preamble is in providing guidance to firms that seek as a practical matter to avoid FDA enforcement action.  This guidance does not appear to resolve significant ambiguities in the regulation.  Therefore, although the preamble is grossly self‑serving, it potentially may not have a great impact in specific cases.

Summary

On the whole, FDA’s proposed rule would do more to clarify intended use if the agency simply deleted the knowledge sentence.  That would resolve a long‑standing contradiction between the regulation and the statutory scheme.  The proposed add‑ons do not, on net, do not appear to add value and actually are likely to sow more confusion than they reap.  FDA’s stubborn insistence on retaining maximum leeway in intended use continues unabated, even at the expense of greater clarity and certainty for industry.

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HP&M’s Dara Levy and Serra Schlanger to Present on Advertising and Promotion

HP&M’s Dara Levy and Serra Schlanger to Present on Advertising and Promotion

Hyman, Phelps & McNamara, P.C. is pleased to announce that Dara Katcher Levy and Serra Schlanger will present at the Food and Drug Law Institute’s virtual Advertising and Promotion for Medical Products Conference on October 28–30, 2020.  This conference will analyze the latest commercial issues related to advertising and promotion of human and animal drugs, medical devices, and biologics.  Dara will moderate a session on Pre-Approval Communications with Payors, focusing on the practical aspects of pre-approval interactions with payors, AMCP Format 4.1, and how companies have adapted their pre-approval communications with payors pursuant to FDA’s 2018 final guidance.  Serra will speak about the Rise of Docfluencers and Nursefluencers, focusing on FTC transparency considerations for sponsored content, FDA rules and enforcement related to physician spokespeople, and the risks of engaging health influencers.

We can offer our readers a discount of 15% off the registration using code AP15.  We look forward to seeing you at this virtual conference.

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Did the Federal Circuit Just Kill ANDA “Skinny Labeling”? – GSK v. Teva

Did the Federal Circuit Just Kill ANDA “Skinny Labeling”? – GSK v. Teva

By Sara W. Koblitz

2020 was supposed to be a year remembered for the 40th anniversary of the publication of the Orange Book—a celebration of one aspect of the Hatch-Waxman Amendments—but it could turn out that 2020 is remembered as the year in which the Hatch-Waxman Amendments took a significant blow to the face.  Specifically, when ANDA (and 505(b)(2)) “skinny labeling” (i.e., labeling carve-outs) was struck down and the generic drug industry faltered.

Carve-outs (or skinny-labeling), in which a generic sponsor uses a “section viii” statement to remove from proposed product labeling any indications or other language covered by a method-of-use patent listed in the Orange Book for a given Reference Listed Drug (RLD), have been pretty routine since the Hatch-Waxman Amendments were enacted in 1984.  Permitted by Congress under Section 505(j)(2)(A)(viii), a section viii statement inherently acknowledges that a given patent is listed in the Orange Book but declares that the patent does not cover a condition of use for which an ANDA applicant is seeking approval.  Although the RLD and generic drug are listed in the Orange Book as A-rated, they are only rated as substitutable insofar as they are labeled the same.  As FDA once stated in the Orange Book Preface: “Therapeutic equivalence determinations are not made for unapproved, off-label uses.”

RLD sponsors, understandably, tend to dislike so-called carve-outs, as they allow generic competitors to access the market without addressing listed patents.  As a result, RLD sponsors often petition to preclude carve-outs on the grounds that a carve out would affect the safety and efficacy of the product for the remaining indications in the labeling.  Typically, FDA rejects these petitions, and the practice is now a staple to facilitate generic competition.  But, even though Congress and FDA accept the practice as commonplace, the Federal Circuit just threw a major wrench in the system.

In a 2-1 decision, the Federal Circuit recently held in GSK v. Teva that skinny-labeling can constitute induced infringement, rendering any generic sponsors who relied on a section viii statement for a method of use patent vulnerable to patent litigation.  As the RLD holder, GSK had listed several patents in the Orange Book for carvedilol (Coreg), initially approved for use in the treatment of hypertension, and subsequently for the treatment of congestive heart failure and left ventricular dysfunction following a myocardial infarction.  GSK listed the ‘069 method of use patent, which was reissued and relisted as the ‘000 patent in November 2003, covering the combination of carvedilol and an angiotensin-converting enzyme (“ACE”) inhibitor, diuretic, and/or digoxin with the use code “decreasing mortality caused by congestive heart failure.”  Teva submitted its ANDA in 2002 with a Paragraph IV certification for the ‘069 patent, and, at some point after the ‘069 patent was reissued as the ‘000 patent, submitted a section viii statement for it, effectively converting its ‘069 Paragraph IV certification to a carve-out.  Teva received tentative approval in June 2003, and launched upon expiration of a different patent in 2007 with an AB rating.  Teva subsequently revised its labeling to include the indication for treatment of heart failure, as required by FDA to ensure that its label was identical to the GSK RLD.

In 2014, GSK sued for induced infringement of the reissued ‘000 patent.  At trial, Teva argued that it had carved-out the treatment of congestive heart failure with a section viii statement, and therefore could not have infringed the ‘000 patent.  The jury sided with GSK, finding that Teva caused physicians to prescribe generic carvedilol for the carved-out indication and therefore willfully induced infringement.  In a rare move, the district court granted Teva’s motion for Judgement as a Matter of Law (“JMOL”) and overturned the jury verdict because GSK did not prove that Teva’s actions caused physicians to infringe.  GSK appealed.

The Federal Circuit reviewed the JMOL de novo, evaluating whether “the record is critically deficient of the minimum quantum of evidence to sustain the verdict” (citations omitted).  Looking at the JMOL standard, the Federal Circuit assessed whether the jury’s findings are supported by substantial evidence and whether the jury’s verdict can be supported by its findings.   In no uncertain terms, the Federal Circuit held that the “criteria of induced infringement are met” based on the “ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides.”  Mainly, the evidence consisted of materials in which Teva had noted that its product was a “generic of Coreg” and “AB rated” without any reference to specific indications.  Notably, the Court implied that the labeling alone may have been enough, as “[p]recedent has recognized that the content of the product label is evidence of inducement to infringe.”  Given that there was substantial evidence to support the jury’s verdict of inducement to infringe the ‘000 patent, the Federal Circuit overturned the JMOL, reinstated the $235 million damages award, and remanded the matter to back to the district court.  The opinion was sure to stress that its decision was not based on policy but purely on applicable patent law.

Federal Circuit Chief Judge Prost vehemently dissented.  Focusing on the “critical balance” of patent rights with public access to innovation, she noted that the Majority decision “undermines this balance,” particularly since Congress specifically provided for the skinny label pathway.  The dissent astutely points out that the Federal Circuit’s holding “nullifies Congress’s statutory provision for skinny labels,” slowing the introduction of low-cost generics.  The dissent stresses that Teva did everything right here, following all statutory and regulatory requirements, never expressly marketing for the carved-out indication, and omitting the indication from its labeling until the method of use patent expired.  With no legally sufficient evidence to support inducement or to support that doctors prescribed generic carvedilol based on any action taken by Teva, the dissent would uphold the JMOL.  To do otherwise, the dissent writes, “undermines Congress’s design for efficient generic drug approval.”

This case highlights the delicate balance that Congress tried to walk between intellectual property rights and facilitating generic drug access when passing the Hatch-Waxman Amendments, and how that balance can be upset by a single court decision.  The evergreening/patent thicket problem just became even bigger for the generic drug industry, as innovators of a product with multiple indications, like cancer drugs that are approved for individual types of cancers, can now—absent a reversal of the panel decision—use a successive method-of-use patent to legally keep all competition off the market indefinitely.

There are also questions of fairness here, as well as reliance interests for generic drug companies.  As Chief Judge Prost pointed out in her dissent, Teva followed the law to a T but is nonetheless on the hook for $235 million.  And generic companies have been doing this for years; are they now all liable for induced infringement?  For industry, the uncertainty leaves a wide open question of whether taking advantage of the skinny label process is advisable.

Given the huge implications here for the generic industry, Teva is sure to appeal this case, either en banc or to the Supreme Court.  But it may be years before we have any certainty.  Neither FDA nor Congress has said anything about this decision yet, but we would be surprised if FDA did not chime in on the issue in some form.  After all, it significantly upsets the Hatch-Waxman balance FDA has strived to achieve and mischaracterizes FDA’s long held position on therapeutic equivalence determinations.

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FDA Requests Comment on Labeling of Cell-Derived Seafood Products Except… Wait For It… Catfish

FDA Requests Comment on Labeling of Cell-Derived Seafood Products Except… Wait For It… Catfish

By Ricardo Carvajal

FDA published a constituent update and Federal Register notice asking for comment on a number of questions pertaining to labeling of “foods comprised of or containing cultured seafood cells.” The notice discusses the basis for FDA’s jurisdiction over such products, as well as misbranding provisions that FDA considers relevant.  The notice then poses a number of questions, including:

  • Should the name or statement of identity of foods comprised of or containing cultured seafood cells inform consumers about how the animal cells were produced?
  • What terms should be in the name or statement of identity of a food comprised of or containing cultured seafood cells to convey the nature or source of the food to consumers?
  • Should names for conventionally produced seafood products established by common usage, statute, or regulation be included in the names or statements of identity of food derived from cultured seafood cells?
  • When comparing conventionally produced seafood to foods comprised of or containing cultured seafood cells, what attributes (such as nutrition, taste, texture, or aroma) vary between the foods and should FDA consider to be material to consumers’ purchasing and consumption decisions?

Doubtless, these questions will prompt the submission of comments and information from both industry and consumer advocacy organizations.

As noted in the Federal Register notice (and as we discussed in a prior blog posting), FDA and USDA previously reached an agreement on oversight of food derived from cells of USDA-amenable species (e.g., cattle, swine, and chickens). Subsequently, GAO issued a report recommending in part that FDA and USDA take measures to more formally and broadly communicate their understanding that FDA will oversee cell-derived seafood products – other than catfish. Those relatively new to food regulation might not be aware that Congress transferred jurisdiction over catfish from FDA to USDA through provisions in the 2008 and 2014 Farm Bills. We recounted that saga here.

The deadline for submission of comments is March 8, 2021. Comments can be submitted here.

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HPM’s Food, Beverage & Supplement Wrap Up: September 2020

HPM’s Food, Beverage & Supplement Wrap Up: September 2020

By Karin F.R. Moore & Ricardo Carvajal & Riëtte van Laack

Welcome to the inaugural edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye.  (Yes, we know that beverages and dietary supplements are “food” within the meaning of the FFDCA, but our international readers might not be aware of that nuance in U.S. law – so please just roll with the title.)

Food & Beverage

  • FSMA Traceability: The FDA has proposed a new rule for FSMA traceability as part of the New Era of Smarter Food Safety initiative. Our initial analysis is forthcoming.
  • Pesticides: FDA issued its annual Pesticide Residue Monitoring Program Report for FY 2018. The Pesticide Residue Monitoring Program is administered by the FDA to ensure that FDA-regulated foods in U.S. commerce comply with the pesticide tolerances, or maximum residue levels, set by the U.S. Environmental Protection Agency (EPA).
  • Strengthening Organic Enforcement: USDA has proposed a rule intended to strengthen organic control systems, improve farm to market traceability, and provide robust enforcement of the USDA organic regulations. Comment period closes at 11:59 pm Eastern on October 5, 2020.
  • Domestic Hemp Production Program: USDA’s AMS is providing an additional thirty (30) days for public comments on the interim final rule that established the Program. The comment period will be open from September 8, 2020 to October 8, 2020.
  • Nutrition Facts Label: On September 18, 2020, FDA announced additional flexibility for manufacturers with less than $10 million in annual food sales who need to comply with updated Nutrition and Supplement Facts label requirements by January 1, 2021. Although the compliance date will remain in place, FDA announced they will not focus on enforcement actions during 2021 for these smaller food manufacturers.
  • Sometimes Denigration is OK: But it has to be truthful, accurate, and narrowly drawn – a fine needle to thread. In a challenge brought by Clif Bar & Company, NAD concluded in part that Kind, LLC’s depiction of two bars in a commercial had a reasonable basis and was not “falsely denigrating.”
  • Enforcement: DOJ announced “the largest-ever criminal penalty following a conviction in a food safety case” – a cool $17.25 million levied against Blue Bell Creameries. See our summary here.
  • Bioengineered Animals: FDA posted a helpful webinar for product developers to help them understand the agency’s expectations for data submitted in support of a new animal drug application. (In the U.S., animals that have undergone intentional genomic alteration are subject to regulation as new animal drugs, even if they are only intended for food use.)

Supplements

  • CRN’s Board voted unanimously to reaffirm that participation in the Supplement OWL is a requirement of association membership for companies that market eligible finished products.
  • Pharmaceutical ingredients found in cognitive enhancement supplements: Merits of the study aside, one possible consequence is increased scrutiny of the quality of products marketed in this category. Hat tip to CRN.

Some Things We Are Monitoring:

Upcoming Events:

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