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 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’s Product Jurisdiction Proposal: More Changes are Needed

FDA’s Product Jurisdiction Proposal: More Changes are Needed

By Jeffrey N. Gibbs & Jennifer M. Thomas

Following our blog post on the topic, in which we urged others to comment in response to FDA’s Proposed Product Jurisdiction rule changes, we decided to take our own advice. On July 15, 2018, Hyman, Phelps & McNamara, P.C. filed comments to Docket No. FDA-2004-N-0191.

Our requests were modest but important, and reflect our deep frustrations with the Request for Designation (“RFD”) process as described in previous posts.   Specifically, we asked the Agency to (1) establish a timeframe for review of RFD decisions by the Office of Special Medical Programs when requested by the sponsor, pursuant to 21 C.F.R. § 10.75, and (2) remove the 15-page limitation for RFDs at 21 C.F.R. § 3.7.  These requested changes would help streamline the RFD process and make it work better for both sponsors and the Agency.

The lack of any timeframe for review of RFD appeals can result in appeals languishing for many months. This delays sponsors from seeking product approval, and may consequently deprive the public of beneficial products for months or years.  The current 15-page limitation also frustrates both the Agency’s and sponsors’ goals by stymieing the free exchange of relevant information about a proposed product.  Fifteen pages is simply not enough to provide FDA with all the requested information for an RFD, especially as FDA continues to place an increasingly high burden on sponsors to establish a product’s mode of action.

In addition to these requests, we asked FDA to reconsider its approach to determining whether a product or product component achieves its primary intended purposes through chemical action, thereby excluding it from the statutory device definition. FDA alluded to this topic in its proposal, but then proposed no changes.  In our experience, FDA’s current approach can wrongly result in a combination product that exhibits very minimal chemical action being regulated as a drug or biologic rather than a device.  This approach – which we have seen repeatedly – is not consistent with the statutory language and should be revisited, particularly in light of the 21st Century Cures Act. Comments filed by the Washington Legal Foundation demonstrate why FDA needs to modify the way in which it makes these jurisdictional decisions.

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Maine Law Aims to Increase Generic Drug Developers’ Access to Reference Samples

Maine Law Aims to Increase Generic Drug Developers’ Access to Reference Samples

By Hyman, Phelps & McNamara, P.C.

By Michelle L. Butler & Eliot Markman* –

On July 4, 2018, 2017 ME S 432, titled “An Act To Require Drug Manufacturers To Comply with Federal Law” (the “Act”), became law without Maine Governor Paul LePage’s signature.  The Act amends 32 M.R.S.A. § 13702-A and requires a drug manufacturer or wholesaler licensed in Maine to make a drug distributed in the State available for sale to “an eligible product developer.”  An eligible product developer is defined as “a person that seeks to develop an application for the approval of a drug under the Federal Food, Drug, and Cosmetic Act [FDC Act], Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health Service Act, Section 351.”  We note that this definition is not limited to a person seeking approval of an ANDA or a biosimilar application.  Although the term “reference sample” is not used in the text of the statute itself, the section discussing the intent of the statute calls the drugs that are to be made available under this provision reference samples.

The Act requires a manufacturer or wholesaler to make the drug available for sale “at a price no greater than the wholesale acquisition cost [WAC] and without any restrictions that would block or delay the eligible product developer’s application in a manner inconsistent with [the FDC Act’s provision prohibiting the use of a REMS program to delay competition].” WAC is defined as “the manufacturer’s list price for a brand-name drug or a generic drug per person per year or course of treatment when sold to wholesalers or direct purchasers in the United States, not including discounts or rebates, for the most recent month for which information is available.”  As a consequence of purchasing a drug under this provision at a price no greater than WAC, the eligible product developer must charge consumers in Maine the same price or less for the drug it manufactures, presumably after obtaining approval from FDA of an application.  The Act permits the State to seek injunctive relief against a person who fails to comply with these new provisions.

A number of questions arise from the language of the Act, including some that raise the specter of a lawsuit:

  • While the title of the Act suggests that it is only working to implement an existing federal requirement, the FDC Act does not require a manufacturer to make drug available to a person seeking to develop a generic or biosimilar drug in all circumstances; rather, under the FDC Act, a manufacturer is not permitted to use a REMS program to block or delay approval of an ANDA or 505(b)(2) NDA.
  • The Act’s requirement for a wholesaler to make drug available may raise issues for the wholesalers. A wholesaler that is distributing drug subject to a REMS and/or closed distribution system would likely be reticent to provide drug to an eligible product developer without the permission of the manufacturer with whom it likely has a contractual relationship that does not permit such distribution.

In addition, the definition of WAC in the Act is not consistent with the real-world definition of WAC. It is appropriate that the definition describes WAC as a list price and does not include discounts or rebates.  However, WAC is the list price for a specific package size of a drug (e.g., a bottle of 100 tablets or a bottle of 1000 tablets) and is not tied to a course of treatment or “per person per year.”  The Act’s definition is likely to lead to confusion.

The Act also includes an exemption from liability for “product of another.” The Act states that a manufacturer or wholesaler is not liable for the failure to include adequate safety warnings or for product defects when the manufacturer or wholesaler has made a drug available to an eligible product developer pursuant to the Act and the product was not manufactured or sold by that manufacturer or wholesaler.  While the language is not entirely clear, it appears that the exemption is intended to shield a manufacturer or wholesaler that provides product to an eligible product developer from liability for the competing generic or biosimilar drug that is ultimately developed and sold by the eligible product developer.

Senate Democratic Leader Troy Jackson, the bill’s sponsor, stated in a press release dated July 5, 2018 that the Act will lower prescription drug prices by making cheaper generic drugs available more quickly after a drug’s patent expires.  According to the press release, the Act is intended to prevent companies from withholding products from generic manufacturers through closed distribution systems that may be implemented as part of a REMS.

We will continue to monitor this and similar laws that states have enacted aimed at curbing drug prices.

* Summer Associate

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FDA Proposes Amendment to Vending Labeling Rule Requirement for Font Size

FDA Proposes Amendment to Vending Labeling Rule Requirement for Font Size

By Riëtte van Laack

In 2010, the Federal Food, Drug, and Cosmetic Act (FDC Act) was amended to include a requirement that certain vending machine operators engaged in operating and owning 20 or more vending machines provide calorie declarations for certain articles of food sold from vending machines. FDA issued a final implementing regulation on Dec. 1, 2014 with a compliance date of Dec. 1, 2016.

The final regulation requires that a prospective purchaser of a product from a vending machine must be provided with calorie information. For glass-front vending machines, the regulation provides the option of front of package (FOP) declaration of the calorie content. In that case, the regulation requires that the “visible nutrition information must be clear and conspicuous and able to be easily read on the article of food while in the vending machine, in a type size at least 50 percent of the size of the largest printed matter on the label and with sufficient color and contrasting background to other print on the label to permit the perspective purchaser to clearly distinguish the information.” FDA received many comments in response to the proposal for this requirement. Even after the publication of the final rule, FDA received comments that the requirement presented technical challenges.

In the Federal Register of Aug. 1, 2016, FDA extended the compliance date for the type size provision to July 26, 2018 to coincide with the original compliance date for the new nutrition labeling regulations. The extension applied only to those products in glass front vending machines that provide FOP calorie disclosure that complied with the vending machine labeling rule, except that the disclosure was not 50 percent of the size of the largest print on the label.

On July 12, 2018, FDA issued a proposal to amend the type size provision to require that the size is at least 150% of the size of the net quantity of contents. FDA invites comments to this proposal.

In addition, FDA invites “comment and data on the percentage of food products commonly sold in glass front vending machines bearing voluntary FOP calorie labeling, and for those products that currently bear voluntary FOP calorie labeling, the type size of the FOP calorie labeling used on the products.”

FDA also requests comments on two alternative amendments to the current provision, namely:

  1. Require that calories are declared in a font at least 100% of the size of the net quantity of contents declaration.
  2. Not specify any size requirement (an option FDA previously considered and rejected).

FDA proposes that any resulting final rule will have an effective date of 30 days after the date of publication and a compliance date of Jan. 1, 2020.

Written comments must be submitted by Sept. 25, 2018.

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PCAST Recommendation in Action: “Wildcard Exclusivity” Proposed for “Priority Antimicrobial Products”

PCAST Recommendation in Action: “Wildcard Exclusivity” Proposed for “Priority Antimicrobial Products”

By Kurt R. Karst

Way back in September 2014, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President, titled “Combating Antibiotic Resistant Bacteria.”  The report was part of a broader initiative announced by the Obama Administration to address the growing challenges posed by antibiotic resistance. Of the various “push” and “pull” mechanisms discussed in the PCAST report to incentivize the development of antibiotics, the “push” mechanism described as “[t]radable vouchers to extend patent life or market exclusivity of another drug” was of particular interest to us.  As we explained back then, this is longhand for “wildcard exclusivity” (see our previous post here).  Fast-forward almost four years, and the PCAST recommendation has found its way into a legislative proposal.

On June 28, 2018, Representatives John Shimkus (R-IL) and Tony Cárdenas (D-CA) introduced H.R. 6294, the Re-Valuing Anti-Microbial Products Act of 2018 (“REVAMP Act”).  The REVAMP Act, which Reps. Shimkus Cárdenas are reportedly trying to get added to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2018, would amend the FDC Act to add Section 530, titled “Exclusivity to encourage development of novel therapies targeting serious microbial infections.”

Proposed FDC Act § 530 would provide that if FDA approves an NDA or BLA for a product designated as a “priority antimicrobial product” under a new designation program described in the bill, then the Agency shall award the application holder a 12-month exclusivity extension period “for the sole purpose of conveying such extension, in whole or in portions, to other sponsors or holders.” The exclusivity would be applied with respect to one or more other drugs for which a 505(b)(1) is submitted to FDA, that is granted 5-year New Chemical Entity (“NCE”) exclusivity, and that is designated as a “fast track product” under FDC Act § 506(b).

The conveyance of exclusivity, in whole or in in part, would need to be immediately communicated to FDA; and, with respect to the recipient drug, would apply to non-patent exclusivity granted under FDC Act §§ 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) (i.e., NCE exclusivity), FDC Act §§ 505(c)(3)(E)(iii)-(iv) and 505(j)(5)(F)(iii)(iv) (i.e., 3-year exclusivity, and FDC Act § 527 (i.e., 7-year orphan drug exclusivity) – and in addition to any 6-month pediatric exclusivity extension in effect.

Ahh . . . but there’s more . . . . In addition to applying to non-patent exclusivity the conveyed exclusivity would also apply to non-patent exclusivity (and in a manner  similar to how pediatric exclusivity is applied to Orange Book-listed patents)!  According to the bill:

(2) DRUGS SUBJECT TO LISTED PATENTS.—Immediately upon the Secretary’s receipt of a notice under subsection (b), the period during which an approval of an application may not be made effective by operation of subsection (c)(3) or (j)(5)(B) of section 505, as applicable, in the case of a recipient drug that is the subject of—

(A) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505;

(B) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505; or

(C) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 if in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed,

shall be extended after the date the listed patent expires (including any patent extensions) for a period equal to the conveyed exclusivity extension period.

In addition, the bill provides that “the holder of a conveyed exclusivity extension period may sell, exchange, convey, or hold for use, such period.” This could result in the creation of quite a market for the sale of exclusivity (somewhat similar to the market created for priority review vouchers – see here).

But the REVAMP Act does include some limits on wildcard exclusivity. For example, the conveyance and notice of an exclusivity extension period for a drug must be made no later than the last day of the ninth year of the NCE exclusivity period, as extended by GAIN (FDC Act § 505E); and for a biological product, the conveyance and notice of an exclusivity extension period must be made – quite literally – at the eleventh hour: “in the case of a priority antimicrobial product that is a biological product, the last day of the eleventh year of the exclusivity period described in section 351(k)(7)(A) of the Public Health Service Act applicable with respect to such product.”  In addition, a period of patent or non-patent exclusivity would not be extended “if the conveyance of an exclusivity extension period . . . or the provision of notice [of exclusivity conveyance] is made later than 4 years prior to the expiration of such period.”  Finally, FDA may make not more than 10 awards of wildcard exclusivity.  (Of course, that could change if the REVAMP Act is enacted and is successful.)

The REVAMP Act also includes a string attached to the granting of wildcard exclusivity:

As a condition on the award of an exclusivity extension period to the holder of a drug pursuant to subsection (a), the Secretary shall require the holder, upon any conveyance of the period pursuant to such subsection, in whole or in portions, to make a monetary contribution to the Foundation for the National Institutes of Health that—

(1) is in an amount that is equal to 5 percent of the total value of the consideration received by the holder as a result of the conveyance; and

(2) is designated to be used by the Foundation to conduct or support early-stage research on the development of products to treat or prevent a disease attributable to a multi-drug resistant bacterial or fungal pathogen.

The remainder of the REVAMP Act describes, among other things, how FDA is to establish a Committee on Developing Critical Need Antimicrobials. The committee would be tasked with developing a proposed list of critical need antimicrobial priorities, supporting the designation of priority antimicrobial products and the review and disposition of applications for priority antimicrobial products, and developing recommendations to FDA and Congress “regarding other incentives needed to ensure a robust and renewable pipeline of antimicrobial drugs.”

As we’ve noted before (see, e.g., here, here, and here), the concept of wildcard exclusivity has cropped up now and again over the years in legislative proposals, and in various forms and contexts. This latest proposal in the REVAMP Act seems to be the most complex arrangement yet.

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Following Regulation, PhRMA and BIO Drop Challenge to State Drug Pricing Law

Following Regulation, PhRMA and BIO Drop Challenge to State Drug Pricing Law

By Hyman, Phelps & McNamara, P.C.

By Alan M. Kirschenbaum & Eliot Markman* –

On Thursday, June 28, 2018, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), agreed to drop a lawsuit against Nevada related to S.B. 539, a 2017 diabetes drug price increase transparency bill. (See our previous blog post about this lawsuit here and the initial complaint here). A joint status report—also filed on June 28, 2018—describes three reasons why PhRMA and BIO agreed to release their claims: (1) Nevada issued an emergency regulation narrowing the statute, (2) the state agreed to delay enforcement of certain reporting requirements, and (3) the parties agreed to reserve their rights to resume litigation. Joint Status Report at 2-4, PhRMA v. Sandoval, No. 2:17-cv-02315 (D. Nev. Jun. 28, 2018).

First, the Emergency Regulation, LCB File No. R042-18 (effective May 31, 2018), amends Chapter 439 of the Nevada Administrative Code to allow companies to petition the Nevada Department Health and Human Services (the “Department”) to keep a manufacturer’s pricing information confidential. The parties explain what information a manufacturer must submit in a request to the Department to keep their drug pricing information confidential: “(1) ‘ . . .  the information sought to be protected from public disclosure,’ [Emergency Regulation] § 3(2)(a); and (2) ‘ . . . an explanation of the reasons why public disclosure of the information would constitute misappropriation of a trade secret [under] the federal [Defend Trade Secrets Act] . . . ,’ id. § 3(2)(b).” Joint Status Report at 3.  The parties acknowledge that Nevada believes that this regulation, on its own, cures any constitutional defect in the statute.  (PhRMA and BIO offer no opinion as to whether the regulation cures any constitutional defect in the statute.)

Second, PhRMA and BIO agreed to drop their lawsuit because Nevada delayed the enforcement of certain reporting requirements in the statute. On June 7, 2018, the Department stated on its website that it would not proceed with enforcement actions related to manufacturers’ reports submitted on or before January 15, 2019. The Department further assured the plaintiffs in emails sent on June 8 that they would not bring any enforcement action against any manufacturer based on the submission of an incomplete report, or even no report, as long as the manufacturer submits a compliant report on or before January 15, 2019.

Third, the parties represented that they were not waiving their rights to future litigation even though they were agreeing to voluntary dismissal without prejudice. Specifically, the parties agreed not to waive the constitutional arguments related to S.B. 539 (summarized in our previous blog post here).

We will continue to monitor this and similar lawsuits against states that have enacted drug pricing laws aimed at curbing drug price increases.

* Summer Associate

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Whither Regulation of Animal Cell-Cultured Foods?

Whither Regulation of Animal Cell-Cultured Foods?

By Ricardo Carvajal

To anyone with an interest in that question, FDA’s public meeting later this week is a can’t miss event.  Perhaps the most critical issue facing this nascent industry is the need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction over which aspects of production and distribution.  In announcing the public meeting, FDA appeared to stake an early claim to jurisdiction, but USDA officials reportedly have indicated that they don’t consider the matter settled. 

The public meeting won’t resolve the jurisdictional question, but will serve as an important forum for stakeholders to make their voices heard (along with the docket for written comments).  It is by no means the only forum that merits attention.  As discussed in our prior postings (see here and here), a petition is already pending with USDA asking that agency to establish formal definitions of “meat” and “beef” that exclude what petitioners call lab grown meat.  Further, Congress has shown interest in potentially weighing in, and any result dictated by Congress may not necessarily align with historical approaches. 

All of this suggests there may be a bumpy ride ahead – and that’s without taking into account the battles that can be expected to unfold in the court of public opinion (see here as just one example).

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New DOJ Policy Purports to Prevent Piling-On of Penalties

New DOJ Policy Purports to Prevent Piling-On of Penalties

By Anne K. Walsh & Rachael E. Hunt

Rather than rolling out the red carpet, DOJ has been highlighting with little fanfare a policy that could prove to be a powerful negotiating tool for companies in the government’s crosshairs. First announced by Deputy Attorney General Rod Rosenstein here, and later reinforced by Acting Associate Attorney General Jesse Panuccio here, DOJ seeks to bring all relevant government actors together when resolving multiple investigations involving the same misconduct. DOJ’s new policy “encourages coordination among Department components and other enforcement agencies when imposing multiple penalties for the same conduct.” Given that a single incident can subject a company to federal, state, and administrative penalties, DOJ’s policy could help provide requisite certainty to regulated industry.

The DOJ policy invokes the familiar football term “piling on,” a situation when multiple players continue to jump onto an existing pile of players who have already tackled an opponent, and thus ending the play. DOJ’s policy discourages “piling on” by instructing various law enforcement entities to appropriately coordinate in imposing penalties on a company, to avoid the “risk of repeated punishments that may exceed what is necessary to rectify the harm and deter future violations.” The new policy also requires DOJ to consider the impact on innocent stakeholders (e.g., employees, customers, and investors) who seek to resolve problems, and to assess “whether devoting resources to additional enforcement against an old scheme is more valuable than fighting a new one.”

The new policy, which has been incorporated into the U.S. Attorneys’ Manual here, has four key features:

  1. Criminal enforcement authority cannot be used to persuade a company to pay a larger settlement in a civil case, such as under the False Claims Act. Such misuse of power would undoubtedly constitute an ethical violation, but the new policy reinforces this principle for aggressive prosecutors.
  1. DOJ components must coordinate with each other to achieve an overall equitable result. This includes crediting and apportioning financial penalties, fines, and forfeitures.
  1. Coordination also is expected among federal, state, local and foreign enforcement authorities.
  1. Last, the policy identifies factors for determining when multiple penalties would be warranted. Relevant factors include the egregiousness of the wrongdoing; statutory mandates regarding penalties; the risk of delay in finalizing a resolution; and the adequacy and timeliness of a company’s disclosures and cooperation with the Department.

Importantly, both DAG Rosenstein and Acting AAG Panuccio highlighted a key benefit of increased coordination by government stakeholders: identifying culpable individuals and holding them accountable. This mantra has been repeated numerous times, most recently in the 2015 Yates memorandum, also available in the USAM.

While DOJ’s new policy seems promising, a practical limitation exists: although DOJ seeks coordination among multiple agencies and regulators, the policy is only binding on DOJ. Although DOJ handles enforcement actions on behalf of many federal government agencies, including FDA, it does not speak for all federal agencies (e.g., SEC). Foreign regulators and state and local enforcement agencies must buy into DOJ policy for true effectiveness.

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California to Pharmacies: Start Balancing your Opioid Checkbook

California to Pharmacies: Start Balancing your Opioid Checkbook

By Larry K. Houck

The Drug Enforcement Administration (“DEA”) and the states are struggling with how to confront the challenges posed by the opioid abuse crisis. One aspect of this problem relates to employee theft, particularly at the pharmacy level. The California Board of Pharmacy (“BOP”), as well as other states, has reported a growing concern with theft reports related to employee diversion. In some cases, there have been instances in which pharmacy technicians and other employees diverted large quantities of controlled substances undetected from pharmacies over a long period of time unbeknownst to the Pharmacist-In-Charge (“PIC”) or consultant pharmacist.

While Federal and State law have long required pharmacies to maintain an inventory of all controlled substances on-hand, and records of controlled substances received and dispensed, there has not been a uniform requirement to routinely reconcile these records. But California’s novel approach to this issue requires all PICs and consultant pharmacists to monitor and account for their pharmacy’s schedule II transactions on at least a quarterly basis, and other controlled substances less frequently. In other words, California is requiring pharmacies to conduct a reconciliation to balance their controlled substance checkbook.

The California BOP believes that “[b]y requiring at least a quarterly inventory of all Schedule II controlled substances, pharmacists, pharmacies, and clinics will be better equipped to spot and stop employee drug diversion from the pharmacy earlier and prevent excessive drug losses from occurring.” Initial Statement of Reasons, Reconciliation and Inventory Report of Controlled Substances, California Board of Pharmacy, 1.

As of April 1, 2018, California pharmacies and clinics are required to conduct periodic inventories and inventory reconciliations for all controlled substances. Cal. Code Regs. tit. 16, § 1715.65(a). Pharmacies, as well as surgical and outpatient clinics licensed by the BOP, must on a quarterly basis complete inventory reconciliation reports for all federal schedule II substances. Id. § 1715.65(c). The regulation does not mandate the frequency for pharmacies and clinics to complete reconciliation reports for other controlled substances. Id. § 1715.65(a). PICs or the clinics’ consultant pharmacists must also establish “secure methods to prevent losses of controlled drugs” and establish written policies and procedures for completing reconciliation reports. Id. § 1715.65(b).

Completing inventory reconciliation reports requires pharmacists or their designees to:

  1. Physically count, not estimate, all controlled substances;
  2. Review all relevant acquisition and disposition records since the last inventory;
    and
  3. Compare acquisitions against dispositions to identify any variances between what
    quantities are accounted for against what should be accounted for. Id. § 1715.65(c)(1)-(3).

In other words, pharmacists must attempt to balance the controlled substances on-hand during the prior physical count and receipts against dispositions and quantities on-hand during the most recent count. Pharmacists should take their physical counts at the Beginning or Close of Business, and document when they took the count. If, For example, the first count was taken at the Beginning of Business on May 1st , the pharmacist will take into account all transactions that occurred on May 1st and afterward; if the count was taken at the Close of Business on May 1st, the pharmacist will exclude May 1st transactions and include only transactions that occurred May 2nd and afterwards.

Ideally there will be no variance and the pharmacy can account for all controlled substances handled during the period. A negative variance can indicate incomplete or inaccurate records or a loss; a positive variance can indicate recordkeeping errors. The reconciliation report must identify the possible causes of any overage, but does not require pharmacies to otherwise notify the board of overages. Id. § 1715.65(c)(5). Pharmacies and clinics must report all identified losses with known causes to the board in writing within 30 days of discovery, and losses by theft, self-use or diversion by a board licensee within 14 days of discovery. Id. § 1715.65(d). The pharmacy or clinic must investigate losses with unknown causes and take corrective action to prevent additional losses. Id.

New PICs must complete an inventory reconciliation report within 30 days of becoming the PIC of a pharmacy. Id. § 1715.65(f). Outgoing PICs should also complete an inventory reconciliation report upon leaving a pharmacy. Id.

Inpatient hospital pharmacies must complete separate inventory reconciliation reports for controlled drugs stored within the hospital pharmacy and for each of the pharmacy’s satellite locations. Id. § 1715.65(g). The PICs of pharmacies that service “automated drug delivery systems” such as Pyxis machines, regardless of where they are located, must ensure that:

  1. They account for all controlled substances added to automated drug delivery
    systems;
  2. Access to automated drug delivery systems is limited to authorized facility
    personnel;
  3. Any discrepancy or unusual access to controlled substances in the automated drug
    delivery systems is evaluated; and
  4. Confirmed losses are reported to the board timely. Id. § 1715.65(h).

The individuals conducting the inventory will sign and date the inventory reconciliation report, and the PIC or professional director of a clinic will countersign the report. Id.
§ 1715.65(e). Pharmacies and clinics must maintain all records used for each inventory reconciliation report in a readily retrievable form for at least three years. Id.
§ 1715.65(c)(4).

The new California inventory reconciliation and loss reporting requirements are stricter than some requirements under the federal Controlled Substances Act (“CSA”), but less strict for others. For example, California requires pharmacists to count schedule II substances quarterly, and other controlled substances quarterly or less frequently, and then reconcile the transactions. The CSA requires registrants to conduct an inventory when they first begin operations and then at least every two years thereafter. 21 C.F.R. § 1304.11(b), (c). The CSA does not require registrants to reconcile their controlled substance transactions.

California requires pharmacies and clinics to report losses and known causes to the board in writing within 30 days of discovery, but they must report losses by theft, self-use or diversion by a board licensee within 14 days of discovery. By contrast the CSA requires pharmacies and clinics to notify the DEA Field Division Office in their area in writing of the theft or significant loss of controlled substances within one business day of discovery. Id . § 1301.76(b). This is usually accomplished via fax or email followed by a Report of Theft or Loss of Controlled Substances, DEA Form-106, when all of the facts are known. California requires pharmacies to report any controlled substance loss while the CSA requires registrants to report all controlled substance thefts and only “significant” losses. FAQs: Inventory Reconciliation Regulation, California Board of Pharmacy, Mar. 30, 2018; 21 C.F.R. § 1301.76(c). In addition, California requires pharmacies to maintain reconciliation records for three years, a year longer than required by the CSA. 21 U.S.C. § 827(b).

In summary, California’s new reconciliation requirement should help pharmacies to identify potential thefts and losses on a timelier basis. On the other hand, it may also result in increased reporting of discrepancies to the California BOP where there may not be a real concern about thefts or losses. It remains to be seen how the California BOP will react to these reports and whether it will increase pharmacy inspections or investigations.

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FSIS Invites Comments on Petition Regarding Product of USA Labeling for Meat and Meat Products

FSIS Invites Comments on Petition Regarding Product of USA Labeling for Meat and Meat Products

By Riëtte van Laack

On June 22, the Food Safety and Inspection Service (FSIS) announced the receipt of a Petition by the Organization for Competitive Markets and the American Grassfed Association to revise FSIS’s policy on “Product of USA” claims so that only U.S. domestic meat and meat products under FSIS jurisdiction can be labeled “Product of U.S.A.”

Under current FSIS policy, described in the FSIS Food Standards and Labeling Policy Book, a “[l]abeling may bear the phrase ‘Product of U.S.A.’” under one of two conditions:

  1. If the country to which the product is exported requires this phrase, and the product is processed in the U.S., or
  2. The product is processed in the U.S. (i.e., is of domestic origin).

Petitioners argue that the current policy allows foreign meat to be imported into the United States and bear the label “Product of U.S.A.” if it simply passes through an FSIS-inspected plant. Petitioners claim that this policy leads to violations of FSIS’s own policies and regulations that prohibit false or misleading labeling and practices.  Moreover, this policy appears to conflict with the Federal Meat Inspection Act’s prohibition on false or misleading labeling, as well as an FSIS regulation that provides that no product shall be labeled so as to give a false indication of origin. Further, Petitioners claim that the current labeling policy “can lead to the disguising of the true origin of the meat and meat products and allows foreign interests and multi-national corporations to take advantage of increased U.S. market opportunities. This can allow for an unfair market advantage for foreign meat and meat products that not only deceives the consumer, but it financially harms U.S. family farmers and independent ranchers.”

The Petitioners ask that FSIS revert to its policy as it stood in 1985. Back then, it was not enough for a product to merely be processed in the U.S. but required  a determination that “significant ingredients having a bearing on consumer preference, such as meat, vegetables, fruits, dairy products, etc., are of domestic origin” Anticipating a large number of comments, FSIS has opened a docket on regulations.gov where comments may be submitted.  Comments should be submitted by August 17, 2018.

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Blind Voting and PMA Advisory Panels: “Do Great Minds Think Alike?”

Blind Voting and PMA Advisory Panels: “Do Great Minds Think Alike?”

By Hyman, Phelps & McNamara, P.C.

By Jeffrey N. Gibbs and David A. Gibbs* –

FDA’s premarket approval (PMA) advisory panels are high visibility events. Both FDA and companies invest heavily in preparing for these meetings.

Thus, when the rules governing PMA panel meetings change, it should be big news. Yet, when FDA revised its procedures on how panels voted in 2010, it didn’t create much of a stir. After all, the changes – going to simultaneous blind voting and asking for separate votes on safety, effectiveness, and benefit-risk – seemed like minor procedural alterations.

Yet, procedural changes can influence outcomes. Thus, we asked what impact these changes had? To do so, we looked at 37 panel votes before the change and 52 votes after the change. The results of the analysis were recently published.

One might have expected the switch to blinded voting to lead to more divided outcomes, since panel members would not be swayed by early voting patterns or dominant voices. The data did not show that. Obviously, other forces could be in play, such as better applications going to panels, and better PMAs presumably would lead to more uniform votes. Still, the results are intriguing and unexpected.

The study found some other interesting patterns. To see what they are, read the article.

Of course, the panel vote is only one part of the process. What’s most important is the ultimate outcome. Our analysis of the data also evaluated the relationship between panel votes and FDA’s final answer: approval or not. These results will be published in a forthcoming article. Stay tuned. You may be surprised by what we found.

*David A. Gibbs is a research analyst at the World Resource Institute in Washington, D.C.

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