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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The End May Be Here: Court Grants DOJ Motion to Dismiss Whistleblowers’ FCA Suit

The End May Be Here: Court Grants DOJ Motion to Dismiss Whistleblowers’ FCA Suit

By Serra J. Schlanger

On November 5, 2019, the U.S. District Court for the Northern District of California added another entry in the long running saga United States ex rel. Campie v. Gilead Sciences, Inc. when it granted the DOJ’s motion to dismiss.  We have extensively covered this case (see here, here, here, here, here, here, here, and here), but an overview is helpful to understand the latest development.

This case results from a qui tam complaint filed in 2010 by two former employees alleging that Gilead made false statements to the FDA about the company’s anti-HIV drugs.  According to the relators, if the FDA had been aware of the false statements it would not have permitted Gilead to market the drugs.  Because the drugs were reimbursed by federal healthcare programs, the relators contended that Gilead’s actions resulted in the submission of false claims in violation of the False Claims Act (FCA).  The DOJ declined to intervene in the case, but the relators chose to proceed with the litigation.  The District Court dismissed the relators’ complaint twice for failure to state a claim under the FCA.  However, in July 2017, the Ninth Circuit Court of Appeals reversed the District Court and found that the relators had alleged sufficient facts to state a claim for relief.  Gilead’s petition for rehearing before the Ninth Circuit was denied, so the company filed a petition for certiorari with the Supreme Court in December 2017.  In April 2018, the Supreme Court invited the U.S. Solicitor General to file a brief expressing the views of the United States on Gilead’s petition.  The DOJ’s Statement of Interest, filed in November 2018, generally agreed with the Ninth Circuit decision but also disclosed that the government would affirmatively seek dismissal of the case if it was remanded.  The Supreme Court denied Gilead’s petition for certiorari in January 2019, and the case returned to the District Court.  The DOJ filed its motion to dismiss in March 2019.

The District Court evaluated the DOJ’s motion to dismiss using the two-step analysis established in United States ex rel. Sequoia Orange Co. v. Baird-Neece Packing Corp., 151 F.3d 1139 (9th Cir. 1998).  Under the Sequoia Orange test, the government’s dismissal of an FCA case may be justified based on “(1) identification of a valid government purpose; and (2) a rational relation between dismissal and accomplishment of the purpose.”  If the government satisfies the two-step test, the burden switches to the relators “to demonstrate that dismissal is fraudulent, arbitrary and capricious, or illegal.”

In its motion to dismiss, the DOJ identified two government purposes to support dismissal of the relators’ suit: (1) to prevent undermining the decisions made by FDA and CMS about how to address the conduct at issue, and (2) to avoid the additional expenditure of government resources on a case that it fully investigated and decided not to pursue.  The relators acknowledged that these purposes have previously been identified by the DOJ as relevant considerations (see our post about the Granston memo), but argued that there was an insufficient factual basis to support the asserted government purposes.

The District Court did not agree with the relators’ assessment, in part due to the “substantial evidence” the DOJ presented about its investigation which included interviews with the relators and other witnesses, consultations with experts from FDA, meetings with Gilead, collection of over 600,000 pages of documents, and review of the history of multiple manufacturing lots identified by the relators as having problems.  The Court also looked at FDA’s oversight of Gilead and noted that history included a Warning Letter, Field Alert Reports, and multiple inspections.  Based on this history, the Court concluded that there was a “concrete factual basis” for the government to argue that allowing the case to proceed would undermine the decisions made by FDA and CMS.

The relators also argued that the DOJ did not provide a factual basis for the second identified government purpose, the cost of continued litigation.  Although the Court noted that the DOJ could have provided a more specific and robust cost analysis, the Court ultimately determined that the DOJ had considered the cost and benefit such that its decision to seek dismissal was supported by a rational basis.  The Court also acknowledged that the facts of this case would likely entail extensive discovery of government witnesses and documents due to the unresolved issue of whether Gilead’s alleged false statements were material.  The Court reasoned that discovery into what the government knew and when could not be avoided if the case continued.

After determining that the DOJ had met the two-step Sequoia Orange test, the Court then concluded that the DOJ’s decision to dismiss this case was not arbitrary and capricious.  As such, the Court granted the DOJ’s motion to dismiss, but noted that the relators could still proceed with their remaining claims.

After almost ten years of investigation and litigation, this may be the end of this saga.  Although this case once seemed destined to provide clarity on the materiality standard established in Universal Health Services. Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), it appears that we may need to continue to wait for that clarity.  However, this case does reveal how the DOJ is implementing the Granston memo and the factors and evidence that may be used to support the dismissal of FCA claims when the government declines to intervene in a qui tam case.

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FDA Finalizes Guidance on Process to Request Review of CFG Denial

FDA Finalizes Guidance on Process to Request Review of CFG Denial

By Jeffrey K. Shapiro

FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG).  What is a CFG?  In many cases, foreign governments will seek official assurance that products exported to their countries are in compliance with U.S. law or meet specific U.S. regulations, such as Quality System Regulations (QSR).  In these cases, firms may request that FDA provide a CFG.  If a domestic firm’s manufacturing establishment has an outstanding Form 483, due to a bad QSR inspection, or is conducting a Class I or II product recall, the non‑compliance may lead FDA to refuse to issue a CFG until it is resolved.

In 2017, Congress amended the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) to establish specific procedural rights and appeal options for device companies faced with a CFG denial.  The following year, FDA issued a draft guidance on how the statutory change will be implemented.  We explained the background and summarized FDA’s draft guidance here.

Our main complaint about the draft guidance was a lack of clarity and detail on implementation of the statute.  We are pleased to report that the final guidance is improved in this regard.  Here are the key points:

Grounds for Denial

Pursuant to the amendment to the FDCA, a CFG may denied in the event of an injunction, a seizure action, a Class I or II voluntary recall, or an establishment out of compliance with the QSR.

If a CFG is denied due to non‑compliance with the QSR, FDA will provide a “substantive summary” of the specific grounds for non‑compliance.  It appears likely that this information will be distilled from the inspectional observations in a Form 483.

Plan of Correction                    

A firm may submit a “plan of correction” responsive to the substantive summary.  FDA states that they interpret a plan of correction to be a response to inspectional observations.  The procedure is as follows:

  • The firm submits via e‑mail the steps it is taking to address the inspectional observations and prevent a recurrence, including timeframes for completing the actions. The email subject line should state “Plan of Correction.”
  • FDA reserves the right to seek clarification of the plan before making a decision. FDA intends to provide a response within 90 days, with due allowance for the complexity of the issues and the responsiveness of the firm.
  • If the plan is determined to be sufficient, FDA will issue a CFG (provided no other grounds of denial are present).

Appeal of Denial

A firm whose CFG has been denied has a right to supervisory review and an opportunity for an in‑person meeting or teleconference.  The appeal must be submitted by email within 60 days of denial.  CDRH will follow its usual procedures (per this guidance).  CBER will use its Formal Dispute Resolution Request (FDRR) process (per this guidance).  In both cases, FDA indicates an intent to follow the standard timelines in Section 517A(b) but does not guarantee it, which may be a questionable interpretation of the statute, which directed FDA to follow the standards of the Section 517A(b).

New Information

A firm whose CFG has been denied has the right to request review of the decision based upon new information, including evidence that corrective actions are being or have been implemented to address FDA’s substantive summary of the grounds for denial.  Once again, this review can be obtained by submitting an email.  Once again, FDA says it will target 90 days for a decision, to the extent possible.

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A right of supervisory appeal of a CFG denial is unlikely to be successful unless FDA has issued a Form 483 that is plainly wrong (a high bar in most cases).  The plan of correction (or the request for review based on new information) appear to offer greater potential.  Since it is likely that FDA will put the most important QSR non-compliance in its substantive summary, a firm could use the vehicle of a plan of correction to help unlock CFGs sooner than would ordinarily be the case.  Additionally, there may be a collateral benefit of obtaining a relatively quick read on FDA’s assessment of a corrective action plan addressing the most serious Form 483 issues.  Certainly, it remains to be seen how FDA actually implements the new procedures, but the final guidance holds out the prospect of improved communication with FDA as firms seek to resolve outstanding Form 483s.

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HP&M Takes Home Tier 1 FDA Law Ranking Honors from U.S. News and Best Lawyers

HP&M Takes Home Tier 1 FDA Law Ranking Honors from U.S. News and Best Lawyers

Hyman, Phelps & McNamara, P.C. (“HP&M”) has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for the 2020 “Best Law Firms” rankings.

“The 2020 rankings are based on the highest number of participating firms and client votes received on record.  Almost 16,000 lawyers provided more than 1,229,000 law firm assessments, and more than 12,000 clients participated providing 107,000 evaluations. . . . This year we reviewed 14,931 law firms throughout the United States – across 75 national practice areas – and a total of 2,106 firms received a national law firm ranking,” according to U.S. News.  The “Best Law Firms” rankings are based on a combination of client feedback, information provided on the Law Firm Survey, the Law Firm Leaders Survey, and Best Lawyers peer review.

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Gene Therapy Company Sues FDA After Being Placed on Clinical Hold

Gene Therapy Company Sues FDA After Being Placed on Clinical Hold

By Deborah L. Livornese

On November 7, 2019, gene therapy company Regenxbio Inc., filed suit in U.S. District Court in Washington, D.C. against FDA asking the court to set aside a partial clinical hold on one clinical trial and a full clinical trial for another.  The complaint also seeks to have a section of the Food, Drug, and Cosmetic Act (“FDC Act”)¾21 U.S.C. §355(i)(3)(B)(ii); FDC Act §505(i)(3)(B)(ii)¾that allows FDA to issue a clinical hold for a reason established by regulation that is other than a determination that the drug involved represents an unreasonable risk to subject safety.

As described in the complaint, FDA issued a clinical hold on the sponsor’s investigative drug for treatment of retinal disease on October 18, 2019 “without notice or explanation,” and has failed to provide the sponsor with a detailed explanation of the basis of the clinical hold other than to say that the INDs were placed on hold due to issues associated with the delivery system.  The company withdrew one IND on October 25, 2019, and the other IND remains on partial clinical hold.  FDA notified the sponsor on November 1st that it would provide a written basis for the hold by “the due date of 11/15/19.”

The complaint also alleges that FDA failed to comply with its regulations because the original email providing notice of the clinical hold did not “briefly explain the basis for the action,” as required by 21 C.F.R. § 312.42(d).  The same regulation also provides that within 30 days after imposition of the hold, the Division Director will provide the sponsor a written explanation of the basis of the hold.  November 15th which is the date by which FDA stated it would provide the sponsor with the written basis of the hold falls within that 30 days based on the dates provided in the complaint.

While it seems unlikely that the merits of the clinical hold will be resolved through the judiciary process in a helpful timeframe, the complaint has likely increased the chances that FDA will respond with a thorough explanation of its reason for the hold when it does provide the written basis.

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Will USDA’s Rule Get Hemp Over the Hump? (Maybe Not Without a Little Help from FDA)

Will USDA’s Rule Get Hemp Over the Hump? (Maybe Not Without a Little Help from FDA)

By Ricardo Carvajal

USDA published its much-anticipated interim final rule establishing a domestic hemp production program, as directed by the Agriculture Improvement Act of 2018 (a/k/a the Farm Bill).  The rule sets out the requirements for hemp production plans developed by States and Indian Tribes that choose to have primary authority over production of hemp within their jurisdiction.  The rule also sets out the USDA hemp production program requirements, which will apply in States and Tribal Nations that don’t have their own plans but choose to allow production of hemp within their jurisdiction.

Generally, all hemp producers will be subject to similar requirements, regardless of whether they are licensed by a State, Tribe, or USDA.  These include obtaining a license, submitting information on land areas under cultivation, securing appropriate sampling and testing for TCH content, disposing of plants containing excess levels of THC, participating in compliance audits, and maintaining appropriate records.  USDA has posted a webinar that provides a high-level overview of what producers can expect.  USDA is also maintaining web pages with resources for state departments of agriculture and tribal governments, hemp producers, and hemp testing labs.

Hemp producers and other stakeholders are encouraged to read the regulation and at least the first 12 pages of the preamble, in which USDA has embedded requests for comments on specific issues.  These include appropriateness of a 15-day sampling window prior to harvest, whether USDA should establish a fee-for-service laboratory approval process, whether labs should be required to have ISO 17025 accreditation, and what efforts should be considered as reasonable in determining whether a producer has committed a negligent violation.  Comments are due by December 30.

Readers with the time and inclination may also find it worthwhile to dive into the Regulatory Impact Analysis in the preamble, which starts with this statement: “The future of the hemp industry in the United States (U.S.) is anything but certain.”  The preamble acknowledges that U.S.-based hemp production recently has seen a “massive resurgence.”  Indeed, hemp acreage reportedly increased 8-fold from 2016 to 2018, and is projected to double in 2019.  However, the preamble states that “it remains unclear whether consumer demand will meet the supply.”  Producer interest is said to be “largely driven by the potential for high returns from sales of hemp flowers to be processed into CBD oil,” but products that contain CBD oil and are intended for human or animal use must still comply with whatever federal and state laws apply to those products – including the Federal Food, Drug, and Cosmetic Act and its implementing regulations.

In discussing projected growth in gross revenues and the potential benefits of its hemp program regulation, USDA pointedly states that, “if FDA does not provide clarity about their plans for future regulation of CBD, there will continue to be uncertainty and downward pressure on the CBD portion of the hemp market….  As a result, full realization of the benefits estimated here could be delayed pending regulatory certainty.”

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FDA Law Alert – November 2019

FDA Law Alert – November 2019

Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement activities affecting the broad cross-section of FDA-regulated industry.   As the largest dedicated FDA law firm, we are happy to help you or your clients navigate the nuances of the laws and regulations affecting them.

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Patient Engagement

  • Patient-Focused Drug Development: James E. Valentine highlights FDA’s guidance on Patient-Focused Drug Development, the second in a series of four guidance documents, which provides approaches to identifying what is most important to patients with respect to their experience as it relates to burden of disease and burden of treatment. Valentine’s post outlines FDA’s new recommendations for quantitative and qualitative research, considerations for specific populations, and the use of social media to elicit patient information.
  • Patient Engagement in Clinical Trials: Véronique Li, Larry J. Bauer and Sarah Wicks write about FDA’s Draft Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations. The guidance delineates between patients, study/research participants and patient advisors, noting that early input from patient advisors could lead to quicker study/research participant recruitment, enrollment and study completion, streamlined data collection and more relevant data outcomes that are important to patients.

Medical Devices

  • Government Investigations: The District of Minnesota required a defendant in a False Claims Act case to turn over to a qui tam relator the presentations the company had made to the government prior to the government’s decision to decline the matter. This post by Rachael E. Hunt, Serra J. Schlanger and Anne K. Walsh discusses the arguments made by Boston Scientific Corporation to protect the materials from disclosure (which ultimately were rejected) and the effect this holding may have on other proceedings to obtain defendants’ presentations.
  • Medical Software Policies and Guidance: FDA issued a series of guidance documents relating to medical software this quarter. Véronique Li describes changes to existing medical software policies resulting from the 21st Century Cures Act, Adrienne R. Lenz details FDA’s second draft guidance for clinical decision support software, and Allyson B. Mullen writes about CDRH’s draft guidance on the Safer Technologies Program.

Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps)

  • Jeffrey K. Shapiro writes about the unique regulatory regime for HCT/Ps, outlines the regulatory definitions of “clinical effect” and “homologous use” and discusses whether advertising the clinical effects/performance characteristics of an HCT/P meets the homologous use regulatory requirement.

Drugs

  • Patents and Drug Innovation: Kurt R. Karst discusses how the legal system may be steering researchers away from drugs that take a long time to develop. In this post, Karst summarizes a recent research paper that focuses empirically on the relationship between the patent incentive and drug innovation.
  • Compounding: Karla L. Palmer discusses several updates to the bulks list prompted by an August decision from the District Court for the District of Columbia that upheld FDA’s strict interpretation of “clinical need” for use of a bulk substance and removal of vasopressin from the Section 503B bulks list discussed here. Shortly after, FDA released a preliminary determination to remove nine other substances from the bulks list while adding five additional substances that Palmer discusses here and here.

Healthcare

  • Fraud and Abuse: CMS and OIG proposed substantial amendments to the regulations implementing the Medicare physician self-referral law (i.e., Stark Law) and the safe harbor regulations under the Federal Anti-Kickback Statute in October. Serra J. Schlanger, McKenzie E. Cato and Alan M. Kirschenbaum highlight the proposed changes in this post.

Food & Dietary Supplements

  • Importation: Riёtte van Laack discusses FDA’s first Warning Letter for a violation of the FSMA’s requirements for a Foreign Supplier Verification Program (FSVP). Her post describes the FSVP requirements, including the new responsibility of importers to ensure that products are held to the same safety standards as domestically produced food.
  • DMHA Regulation: Douglas B. Farquhar and Ricardo Carvajal discuss the 11th Circuit Court of Appeals concurrence with FDA that DMAA (1,3-dimethylamylamine) is not a “botanical” or a “constituent” of botanicals and that Hi-Tech Pharmaceuticals, Inc. should not have sold DMAA as a dietary supplement. See their post for details about FDA’s and Hi-Tech’s arguments and stay tuned for further developments in other Hi-Tech litigation previously blogged about here.

DEA & Cannabis

  • Medical Cannabis: John A. Gilbert and Larry K. Houck continue the discussion of DEA’s planned doubling of the 2019 aggregate production quota for marijuana (prior posts here and here), which would require DEA to act on pending marijuana manufacturer registrations. Their post describes DEA’s announcement to propose additional regulations to address the process and the many questions that remain unanswered.

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Hyman, Phelps & McNamara has its finger on the pulse of FDA. Our technical expertise and industry knowledge are exceptionally wide and deep. Our professional team possesses extensive experience with the universe of issues faced by companies regulated by FDA.  Please contact us for any questions on the issues described here or others affecting the FDA-regulated industry.

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Useful Tips That Could Help In Hiring The Best Criminal Lawyer

Useful Tips That Could Help In Hiring The Best Criminal Lawyer

If you are stuck in a criminal case, it is, of course, important that you must find out ways and means by which you can come out of the situation without any damage. Criminal accusations can be devastating for the individual and if he or she is married, it could create a lot of problems for the entire family. Hence, the first step is to hire the right criminal defense lawyer in Sugar Land and other surrounding areas. This is easier said than done because of many reasons. If you spend some time researching and gathering information about criminal lawyers in this city and surrounding areas, you will perhaps come across dozens of lawyers. Therefore, you may find it tough choosing the right professional who can meet your requirements. Your ability to defend yourself successfully depends on the quality of the criminal lawyer you hire. We are listing down some of the most important points to be kept in mind when it comes to hiring these professionals.

 Is He or She The Best For You?

It is not enough to choose the best criminal lawyer in town for handling your case. You must make sure that he or she is good enough to handle your case. There is no point in hiring the most well known and prestigious criminal lawyer if such hiring does not meet the purpose for which it is being done. In other words, an average criminal lawyer could be the best when it comes to handling your case. Therefore, it is important to choose the best who can meet your specific needs and requirements.

 Experience & Expertise Matters

 Though there are many criminal attorneys in Fort Bend, not all of them are the same. While some specialize in criminal law, there could be others who may be good at the personal injury. If the case relates to violent crime it would not be right to hire a lawyer who specializes in rash driving or who handles cases related to DUI. Hence, you must check on the experience of the criminal lawyers in their specific areas and then decide as to who the best is.

Have A Look At The Team

 When there is a need to present a case to the court, we have to understand that it is not a one-man job. It has to be done by a team. Hence, any good criminal defense lawyer in Stafford must have a professional and well-oiled team behind him or her. The team should be a good combination of administrative staff and paralegals. This will help the case to move forward smoothly without too much trouble.

 Importance of References

 Any good criminal lawyer will have many positive references to offer. It would be a good idea to ask recommendations from associates and friends. It also would be a good idea to take references from previous clients and if possible you should talk to them. Good lawyers have a reputation to protect and preserve and therefore they will not do anything that could spoil their image. When you go with positive references you can be sure that you are hiring a criminal lawyer who has stood the test of time and has a good reputation among dozens of clients.

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Nutrition Labeling Developments: Final Rule Regarding Vending Machine Calorie Labeling and Enforcement Discretion

Nutrition Labeling Developments: Final Rule Regarding Vending Machine Calorie Labeling and Enforcement Discretion

By Riëtte van Laack

Final rule regarding vending machine calorie labeling

Almost 5 years ago, as part of nutrition labeling requirements under the ACA, FDA issued a final rule which requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines.  Under that rule, vending machine operators may choose to rely on front-of-pack (FOP) labeling to disclose calories on food items that consumers can see in glass-front vending machines, provided the declaration for calories is at least 50% of the size of the largest printed matter on the label.  FDA had received several objections against the type size requirements for the FOP, arguing that the requirement was impractical, needlessly burdensome, and would disrupt existing voluntary industry FOP nutrition labeling programs.

In response, FDA proposed to revise the type size requirement to be linked to the size of net quantity of contents statement rather than to the largest printed matter on the front panel.  On October 28, 2019, FDA issued the final rule.  The final rule is largely the same as the proposed rule.  FDA made a minor revision clarifying that the size must be at least 150% of the required minimum size of the net contents statement, rather than 150% of the net contents statement as it actually appears on the label. FDA also clarified that only the numerical value indicating the total calories, rather than the word “calories,” is subject to the final rule’s type size requirements.

The compliance date for the new font size requirement is July 1, 2021. FDA also announced that it will continue its enforcement discretion with respect to the vending machine labeling requirements for gums, mints, and roll candy products sold in glass-front machines in packages that are too small to bear FOP labeling. FDA had previously announced its intention to exercise enforcement discretion until at least January 1, 2020, to allow for further consideration of the issue. In the final rule, FDA announced that it will continue to exercise enforcement discretion for these products on an on-going basis.

More enforcement discretion re nutrition labeling for retail foods

In case you missed it, at around the same time as FDA issued the final rule re FOP calorie labeling for vending machine, FDA “announced” enforcement discretion for nutrition labeling of foods sold at retail.

As readers of this blog know, FDA published amended (new) nutrition labeling regulations in 2016.  Changes were quite extensive, and FDA set the compliance date at July 26, 2018, for manufacturers with more than $10 million in annual sales (smaller companies were to get an additional year).  However, upon requests from industry and, in light of timing of FDA’s review of dietary fiber petitions, questions about added sugar labeling, etc., the compliance date was extended to Jan. 1, 2020.  Although this could have been enough time to revise labels, the timing of pertinent FDA guidance, FDA’s action in response to the Farm Bill prohibiting FDA from requiring the declaration of added sugars on single ingredient product, and some other issues caused industry to request for additional time to comply.  Last week, FDA responded to that request by updating its webpage “Industry Resources on the Changes to the Nutrition Facts Label,” questions and answers. This webpage now states that the agency does not intend to take enforcement actions related to the new nutrition labeling requirements for the first six months following the January 1, 2020 compliance date.  Specifically, FDA added the following Q&A:

I understand that the FDA has received multiple requests from manufacturers to provide additional time to comply with the new requirements. Do I still have to meet the January 1, 2020, compliance date?

The FDA has heard from several manufacturers and groups that more time may be needed to meet all of the requirements.  Therefore, during the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.

As we have mentioned before, the Industry Resources webpage provides useful information and anyone working on nutrition labeling should check out the page regularly.

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FDA Does Away with the Compliance Policy Guide for Homeopathic Drug Products

FDA Does Away with the Compliance Policy Guide for Homeopathic Drug Products

By Riëtte van Laack

In two Federal Register notices and the denial of a citizens petition, FDA laid out a revised enforcement program for homeopathic drugs.

Under the FDC Act, just as allopathic drug product, homeopathic drug products are subject to new drug requirements related to approval, adulteration, and misbranding.  However, historically drug products labeled as homeopathic have been manufactured and distributed without FDA approval and with perceived Agency tolerance under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400 from 1988.  This permissive regulatory posture allowed the growth and expansion of a market for safe, properly manufactured homeopathic products as the public interest in nutrition and alternative therapies has grown.

However, as readers of our blog may recall, in response to comments resulting from an FDA public hearing in 2015 and several incidents related to improperly manufactured homeopathic drug products, FDA more recently became concerned about safety.  In 2017, the Agency announced the availability of a draft guidance describing FDA’s intent to switch to a risk-based enforcement approach to homeopathic products marketed without FDA approval.  In the 2017 draft guidance, FDA indicated that it would withdraw the CPG once it finalized the new guidance, because, according to the Agency, the CPG is inconsistent with a risk-based approach to regulatory and enforcement action.

The draft guidance, particularly FDA’s proposal to withdraw the CPG once the guidance, generated many adverse comments. In 2018, Americans for Homeopathy Choice petitioned FDA to keep the CPG or convert it to a regulation so as to allow the continued marketing of and consumer’s access to homeopathic drug products.

FDA was not convinced.  In actions last week, the Agency not only denied the Petition, it also decided to withdraw the CPG now rather than wait until it finalizes the draft guidance.  According to the Agency’s announcement, FDA has concluded that CPG 400.400 is inconsistent with the Agency’s risk-based approach to enforcement generally and that the CPG no longer accurately reflect the Agency’s current thinking.  FDA stresses, both in the announcement of the withdrawal and in its denial of the Petition, that the withdrawal of the CPG does not represent a change in the legal obligations that apply to homeopathic drugs under the statutes FDA administers.

FDA also announced issuance of a revision to the 2017 draft guidance.  The revised draft guidance includes a definition of “homeopathic drug product” for purposes of the guidance, additional explanation of some of the safety issues that contributed to the development of the draft  guidance, and clarification of FDA’s intent to use risk-based factors to prioritize enforcement and regulatory actions involving the marketing unapproved homeopathic products.

Until the draft guidance is finalized, FDA intends to apply its general approach to prioritizing regulatory and enforcement action, which involves risk-based prioritization considering all the facts of a given circumstance.

To ensure that the Agency considers comments to the draft guidance before it begins work on the final version of the guidance, comments should be submitted by January 23, 2020.

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The High Costs of “Weaponizing” Discovery Strategies

The High Costs of “Weaponizing” Discovery Strategies

By Faraz Siddiqui & Anne K. Walsh

What do you get when you “cross an approach to discovery à la Inspector Clouseau with a corporate lawyer caricature found in cartoon caption contests?” According to Judge Steven Rau of the District of Minnesota in a 32-page order that required an “exhaustive” 15-page factual outline, you would get the 2011 qui tam case U.S. ex rel. Higgins v. Boston Scientific Corp., 11-cv-02453, Dkt. No. 313 (D. Minn. Oct. 16, 2019).  In this “disaster” of a case, Judge Rau sanctioned Defendant Boston Scientific Corporation (BSC) for failing to disclose a “central” witness until the final day of a year-long discovery. Notably, the court justified its finding that BSC acted intentionally with respect to its discovery strategy because an alternative finding would mean that BSC acted nefariously during the nearly five-year government investigation that preceded this case.

Higgins caught our attention earlier this month due to the potential ramifications of Judge Rao’s dramatic decision ordering BSC to produce presentations it had made to the government as part of settlement discussions.  We explained how this ruling could potentially discourage defendants from engaging in candid discussions with the government in the future.

Here, the court issued a new order regarding BSC’s failure to identify four key custodians until the final day of a year-long discovery process. One of these witnesses, Erika Huffman was “central” to the litigation, given her communications with FDA on pertinent matters. The court found that these incomplete discovery disclosures violated BSC’s disclosure obligations under Rule 26 because they were without any justification, they “prejudiced” the Relator, and affected the “entire course of discovery in this matter.” Moreover, “it [was] readily apparent to the Court that this was an intentional discovery tactic by Boston Scientific . . . Essentially, Boston Scientific calculated that since the discovery endpoint was not likely to shift, it would be worthwhile to delay and obstruct discovery to hamstring Relator’s efforts to gather information to support his claims.” The court said that it “will not reward such gamesmanship.”

The court rejected BSC’s arguments that the Relator should have realized Huffman’s importance to the litigation as “disingenuous and mendacious.” By that token, the court reasoned, BSC itself should have realized Huffman’s importance—particularly after going through a 4.5-year government investigation on the matter. He found BSC’s arguments that it did not know that Huffman had discoverable information “absurd” and “stretch[ing] all credulity,” given that BSC “operates in a heavily regulated medical device industry and, as such, has compliance departments in contact with federal agencies like the FDA.” The court concluded that BSC “intended to use Huffman as a witness and hid that information until the final moments of discovery.”

Of particular note is how the court related BSC’s behavior at discovery to its actions during the government qui tam investigation. The court reasoned that “either Boston Scientific knew of Huffman’s importance and deliberately left her off its list of initial disclosures,” or the company “withheld documents from the federal government during its investigation.” The court concluded that it was “much more palatable to believe Boston Scientific committed a discovery violation than impeded a government investigation.” Order at 22-23.

In the end, the judge used the judicial discretion permitted under Fed. R. Civ. P. 37(c)(1) and tailored sanctions for the circumstances of the case in an effort to “cleanse” the “taint of Boston Scientific’s Rule 26 violation.” The court ordered BSC to produce within 14 days all documents from the four newly disclosed custodians that hit on the parties’ search terms; barred BSC from using any documents or testimony that had not been produced to Relator in the normal course of discovery; and required BSC to pay Relator’s costs and attorney’s fees for this motion and for any additional discovery required beyond the discovery deadline. The court did not go as far as to apply an “adverse inference sanction,” as requested by Relator, but left open that possibility “should Boston Scientific fail to meet its obligations under this Order.” Although judge Rau called out the Relator for not being diligent enough and backloading discovery to near the end of the process, he refused to punish “the bully and the victim” equally, where the “Relator was essentially fighting with a blindfold on because of Boston Scientific’s discovery actions.”

This case illustrates the risks defendants face when litigating claims declined by the government.  Not only are there tremendous costs for the protracted investigation and discovery process, but even “technical” discovery violations can result in painful rulings that could potentially affect the outcome of the case. The judge’s admonition to outside counsel is also worth noting. “Even if lead counsel was merely implementing directives from Boston Scientific’s in-house counsel, lead counsel ultimately bears the burden of Boston Scientific’s actions. . . . [I]t was outside counsel’s obligation to actually counsel Boston Scientific as to the propriety of such a tactic.” Order at 27, n.13 (emphasis in original).

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