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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Trump Budget Proposal Would Further Cheapen Generic Drug 180-Day Exclusivity

Trump Budget Proposal Would Further Cheapen Generic Drug 180-Day Exclusivity

By Kurt R. Karst

On Monday, the Trump Administration released a proposed Fiscal Year 2019 Budget.   Tucked into the Proposed Budget are provisions concerning 180-day generic drug exclusivity that garnered quite a bit of discussion earlier this week at the Annual Meeting of the Association for Accessible Medicines in Orlando, Florida.  While the provisions – which certainly were not proposed for inclusion in the Budget by the generic drug industry – are billed as an incentive to increase generic drug competition, if written into legislation and enacted, the Budget proposal may, in fact, have exactly the opposite effect.  But before we get to that item, let’s take a look as what the Proposed Budget provisions say. . . .

Page 51 of the Proposed Budget states:

[T]he Budget proposes to give the Food and Drug Administration (FDA) greater ability to bring generics to market faster by incentivizing more competition among generic manufacturers. This would lead to greater access for consumers to safe, high-quality, and affordable generic drugs and would improve health and quality of life through FDA’s advances in shaping medical practices.  The proposal ensures that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period.  Under this proposal, when a first-to-file generic application is not yet approved due to deficiencies, FDA would be able to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock, rather than waiting an indefinite period for the first-to-file applicant to fix the deficiencies in its application.  Triggering the start of the 180 day-exclusivity period for first-to-file applicants who “park” their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers.

Page 150 of the Proposed Budget, in a section titled “Major Savings and Reforms,” states:

The Budget proposes to give the Food and Drug Administration greater ability to bring generics to market faster by incentivizing more competition among generic manufacturers. This proposal would result in substantial savings to Medicare. The Budget proposes to ensure that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period. The proposal makes the tentative approval of a subsequent generic drug applicant that is blocked solely by a first applicant’s 180 day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180 day exclusivity. This means the period of exclusivity would immediately begin for the first filer.  This proposal will enhance competition and facilitate more timely access to generic drugs.

Finally, the HHS budget document states on page 15:

The Federal Food, Drug, and Cosmetic Act provides an incentive to generic drug applicants by granting a 180 day period of exclusivity to the applicant that is first to file a substantially complete application to FDA. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to health care for more patients.

Some “first filers” can block subsequent generic competitors from receiving approval under this exclusivity provision. Similarly, first filers that receive tentative approval but then intentionally delay seeking final approval can block subsequent competitors. As a result, first filers can “park” their exclusivity, and consumers are denied access to generic products and must keep paying brand price.

The Budget includes a legislative proposal to address this problem. The proposal makes the tentative approval of a subsequent generic drug applicant that is blocked solely by a first applicant’s 180-day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180-day exclusivity. This means the period of exclusivity would immediately begin for the first filer. This proposal will enhance competition and facilitate more timely access to generic drugs.

This proposal is estimated to create $1.8 billion in Medicare savings over 10 years.

. . . and on pages 68 and 85:

Change Conditions on First Generic Exclusivity to Spur Access and Competition

Effective FY 2019, this proposal makes the tentative approval of a subsequent generic drug applicant that is blocked solely by a first applicant’s 180-day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180-day exclusivity. See the Food and Drug Administration chapter for a proposal description. [$1.8 billion in Medicare savings over 10 years]

Change Conditions on First Generic Exclusivity to Spur Access and Competition

This proposal makes the tentative approval of a subsequent generic drug applicant that is blocked solely by a first applicant’s 180-day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180-day exclusivity. [Budget impact not available]

So, the concern is about so-called “parking” of 180-day exclusivity by a first applicant. And the remedy proposed in the Budget would require a change to the statute that would trigger the running of 180-day exclusivity when FDA tentatively approves a subsequent Paragraph IV ANDA, the fist applicant’s ANDA is not approved, and the only basis for FDA granting tentative approval to a subsequent applicant is a 180-day exclusivity block.

We’ve seen a shade of this proposal before . . . . Back in August 2003, while Congress was debating what would eventually become the Medicare Modernization Act (“MMA”), there was discussion of a similar issue.  Ultimately, however, Congress settled on the current six forfeiture provisions.  Those provisions significantly cheapened the value of 180-day exclusivity by making it possible for multiple (sometimes dozens of) generic drug manufacturers to qualify as first applicants eligible for 180-day exclusivity.  Now, the Trump Administration is seeking to further cheapen 180-day exclusivity by urging passage of a provision under the guise of promoting generic drug competition and savings.  But is the proposal a remedy in search of a problem . . . and a problem itself?

First, it should be noted that the MMA’s forfeiture provisions have worked relatively well over the past 15 year to address alleged “parking” of 180-day exclusivity. One need only look to a recent decision from the United States District Court for the District of Columbia for evidence that 180-day exclusivity can be triggered by a subsequent applicant. Moreover, the scenario contemplated in the Proposed Budget seems to be relatively rare, and is sometimes worked out among generic drug manufacturers so that both parties benefit (see our previous post here).

Second, further cheapening the value of 180-day exclusivity does not promote generic drug competition and savings.  In fact, it may have just the opposite effect.  If generic drug manufacturers have less security that they may benefit from 180-day exclusivity, then they may be less likely to submit ANDAs and challenge Orange Book-listed patents in the first place.

Third, by triggering 180-day exclusivity upon the tentative approval of a subsequent applicant’s ANDA, a first applicant can be caught totally off-guard as it is not possible to know when FDA might tentatively approve a subsequent applicant’s ANDA.  This disrupts launch planning and could significantly affect patent settlement agreements, which can promote earlier generic drug entry.

And fourth, the Trump Administration’s proposal could lead to monkeyshines among ANDA applicants (as first applicants seek to work deals with subsequent applicants or submit citizen petitions to prevent tentative approval) and among NDA holders and ANDA applicants.

If the provision proposed in the Budget has any legs, then it needs to be reworked to be less draconian. For example, instead of automatically triggering 180-day exclusivity, a subsequent applicant’s tentative approval could trigger a 75-day countdown to forfeiture similar to the 75-day period under the current failure-to-market forfeiture provision.  Anything less is untenable and would further erode the incentive Congress contemplated when it passed the Hatch-Waxman Amendments in September 1984.

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Traditional vs Clean Meat: Cattlemen Ring the Bell for Round 1

Traditional vs Clean Meat: Cattlemen Ring the Bell for Round 1

By Riëtte van Laack

Clean or cultured meat are terms used for animal muscle produced by growing cells directly rather than via the rearing and slaughtering of an animal. The idea of growing meat (or muscle) from cells outside the body (in vitro) to produce a product that replicates the characteristics of a product obtained from muscle harvested from slaughtered animals has been contemplated for a long time. In recent years, tools have been developed that have made the commercial production of a muscle food product in vitro a real possibility. As startup companies in the United States and elsewhere have gotten closer to getting an actual product to the market, the regulation of this type of product has become a topic of discussion.

Many questions arise. Who will regulate this product, USDA, FDA, or both agencies? How should this type of product be named? If it is grown from muscle cells and looks and tastes like meat, should it be called meat? And if yes, how should it be distinguished from traditionally produced meat which is obtained from a carcass after an animal has been slaughtered?

Apparently concerned about the effect the marketing of this type of meat product may have on the “traditional” industry, the United States Cattlemen’s Association (USCA) filed a petition with the USDA Food Safety and Inspection Service (FSIS) asking that FSIS establish formal definitions of “meat” and “beef” that exclude what petitioners call lab grown meat and products prepared from plant or insect protein. USCA asks that FSIS require that any “product labeled as ‘beef’ come from cattle that have been born, raised, and harvested in the traditional manner,” rather than from “alternative” sources such as a synthetic product from plant, insects, or any product grown in laboratories from animal cells. USCA further asks that FSIS narrow the definition of “meat” to “the flesh of animals that have been harvested in the traditional way,” and that FSIS add these new definitions to the FSIS Food Standards and Labeling Policy Book.

In support of its petition, USCA discusses the definition of “meat” and “beef” in common dictionaries and by USDA, the Federal Trade Commission’s (FTC’s) truth in advertising standard, and the labeling of “alternative products” as beef and meat in the market place. Somewhat surprisingly, USCA also cites FDA’s actions regarding Just Mayo in support of its petition; although FDA initially objected to that name for a product that failed to meet the standard of identity for mayonnaise by virtue of not containing egg, the Agency ultimately allowed the marketing of the product with that name provided that the product was clearly identified as egg-free.

This Petition formalizes regulatory consideration of an issue that until now was being considered informally, and bears watching on that basis alone. The Petition is limited to beef. Since development of clean pork and poultry is proceeding apace, it will be interesting to see if traditional producers of those animal products will follow USCA’s lead. We will be keeping an eye on this issue as it unfolds.

A hat tip to K&H’s The Daily INTAKE for putting this petition on our radar.

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A Heavy Homework Assignment for Food Importers and Producers

A Heavy Homework Assignment for Food Importers and Producers

By Ricardo Carvajal

Barely a week apart, FDA announced the publication of a slew of guidance documents intended to further implement the food supply chain-related provisions of the Food Safety Modernization Act (FSMA).  In this posting, we look at the first set of documents, published on January 24.  In an upcoming posting, we’ll look at the second set of documents, published on January 31.

The first set of guidance documents – some draft, some not – brings home the extent to which the Agency is leveraging importers and producers to help ensure the safety of food, regardless of its origin.  The documents also show the difficulty of trying to weave together the FSMA regulations in a way that is comprehensible and doesn’t result in undue burdens or complexity.  Any party involved in the importation and production of food should closely read these documents, which are briefly summarized below.

  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry (Draft Guidance) – This 108(!) page draft guidance includes Q&As on a range of topics, including:

    • Applicability of the regulation under given circumstances (e.g., importation of food contact substances; return of  U.S. goods by a foreign purchaser; importation of live animals)
    • Requirements of an FSVP (e.g., single vs. multiple FSVPs depending on types of food imported and the number of suppliers; whether a supplier’s process or procedure provides at least the “same level of public health protection” – a potentially complex analysis that is the subject of its own guidance (see further below); FSVP obligations that apply to receiving facilities under the preventive controls regulation)
    • Qualifications of individuals who develop an FSVP and perform FSVP activities, as well as auditors
    • Conduct of a hazard analysis (e.g., identification of known or reasonably foreseeable hazards; obligation to address hazards that are intentionally introduced; records that must be maintained)
    • Conduct of an evaluation for foreign supplier approval and verification (e.g., scenarios where a foreign supplier relies on its supplier to control a hazard; evaluation of a supplier’s compliance with FDA food safety regulations; circumstances under which the risk posed by a food and a foreign supplier’s performance must be reevaluated)
    • Conduct of foreign supplier verification activities (e.g., how to satisfy this obligation when purchasing food from a broker or distributor; factors to consider in selecting appropriate verification activities; conduct of onsite audits; verification activities for hazards related to transportation; mitigation of conflicts of interest)
    • Importation of foods that can’t be consumed without a hazard control, or where a hazard is controlled subsequent to importation, including provision of disclosure statements
    • Corrective actions, including examples of such actions and assessment of actions taken by a supplier
    • Identification of the FSVP importer at entry
    • Maintenance of FSVP records (e.g., retention, storage, and availability to FDA; translation of records in a foreign language)
    • FSVP requirements applicable to importation of dietary supplements (e.g., rationale for modified requirements and criteria for eligibility; obligations with respect to importation of finished dietary supplements)
    • Requirements applicable to very small importers and to importation of certain foods from countries with an officially recognized or equivalent food safety system
    • Consequences of failure to comply (e.g., issuance of 483s and warning letters; refusal of admission; import alert; civil and criminal actions; and debarment)
  • Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide – This much shorter guidance focuses on modified procedures for importers that qualify as a “very small importer” as that term is defined in the FSVP regulation, as well as importers of food from certain small foreign suppliers (e.g., qualified facilities and farms that grow produce but are not “covered farms” as that term is defined in the produce safety regulation).  The guidance also addresses modified requirements applicable to importers of dietary supplements and components, and of food from countries with officially recognized or equivalent food safety systems.
  • Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507: Guidance for Industry (Draft Guidance) – In FDA’s words, “[t]his guidance describes FDA’s current thinking on considerations for determining whether a measure or procedure used in lieu of an FDA requirement in 21 CFR part 112, 117, or 507 provides the same level of public health protection (SLPHP) as the corresponding FDA requirement.”  Ugly as the acronym SLPHP may be, it’s best to get used to it because it represents a core concept integrated into several FSMA regulations.  FDA can be expected to closely scrutinize the basis for an SLPHP determination.  The guidance sets forth “Points to Consider” that are “intended to provide a general framework for evaluating the adequacy of a measure to provide the necessary level of public health protection that FDA determined is appropriate by establishing the corresponding requirement” – a potentially heavy lift, given the effort ordinarily expended by FDA in establishing food safety requirements.  The guidance forthrightly flags FDA’s expectation that “an SLPHP determination should be supported by sound scientific evidence that is analyzed by competent individuals, taking into account any unique measure-specific considerations.”  That said, the guidance recognizes that the scope of an SLPHP evaluation can vary widely, and one can reasonably expect that the corresponding burdens will vary accordingly.  The Points to Consider included in the draft guidance are listed below:

    • Are the relevant data and information in support of the use of a measure sufficient to make a determination that the measure provides the “same level of public health protection” as the corresponding requirement?
    • Are there any unique considerations relevant to the level of public health protection provided by that measure?
    • Was the evaluation of scientific and technical evidence conducted by competent individuals using an appropriate process?
    • Is the determination of “same level of public health protection” properly documented?
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 15: Supply-Chain Program for Human Food – FDA previously issued the first six chapters of this draft guidance.  Issuance of another chapter that focuses on the supply-chain program requirements in part 17, subpart G dovetails with the issuance of the FSVP guidance documents discussed above.  Chapter 15 weighs in at a solid 49 pages and addresses numerous topics, including:

    • The definition of “receiving facility” (with examples), and the circumstances under which certain activities required of a receiving facility can be conducted by other entities
    • The role of a corporate parent in establishing a supply-chain program
    • How to deal with situations where a supply-chain-applied control is applied by an entity other than a supplier
    • The use of sampling and testing as a supplier verification activity
    • What types of records constitute “relevant food safety records”
    • Factors to consider in approving a supplier and determining appropriate supplier verification activities (e.g., a supplier’s food safety history)
    • Development of written procedures for receiving raw materials, including those received from brokers or distributors
    • Alternative supplier verification activities when a supplier is a “qualified facility”
    • Qualifications of a “qualified auditor” (including the need for “at least some actual experience in auditing”)
    • Summary of several types of records required to document a supply-chain program
  • Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry – This guidance states FDA’s intent to exercise enforcement discretion with respect to certain requirements in the regulations on preventive controls for human and animal food, produce safety, and FSVP.  The scope of this exercise of enforcement discretion is summarized in a handy fact sheet. As one especially notable example, each of the four regulations includes a requirement that a manufacturer/processor/importer disclose to its customer when a food is not processed to control an identified hazard, and obtain in return a written assurance that the hazard will be controlled.  Based on “feedback from industry expressing concern that certain product distribution chains would require vastly more written assurances… than anticipated by FDA during the rulemaking process,” FDA will not enforce the written assurance requirements pending the initiation of amendatory rulemaking.

Comments on the three draft guidance documents discussed above are due by May 25, 2018.

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Budget Act Increases Brand Drug Companies’ Discounts Under Government Programs

Budget Act Increases Brand Drug Companies’ Discounts Under Government Programs

By Alan M. Kirschenbaum

Buried in the 250 pages of the Bipartisan Budget Act of 2018 (BBA 2018), which was signed by President Trump on Friday, February 9, are several provisions directly affecting the discounts brand drug manufacturers must pay under federal drug benefit programs:

Increase in Part D Coverage Gap Discount (BBA 2018 section 53116): The first provision will substantially increase coverage gap discounts payable by brand manufacturers under the Medicare Part D prescription drug benefit beginning in 2019. Under Part D, enrollees have heightened co-insurance responsibilities in the so-called coverage gap – i.e., the annual period after the enrollee and the plan have spent a specified amount on covered drugs ($3,750 in 2018), but before the enrollee’s out-of-pocket costs reach the catastrophic coverage threshold ($5,000 in 2018). Under the Coverage Gap Discount Program, the manufacturer of an innovator drug (i.e., a drug approved under an NDA or BLA) dispensed to an enrollee in the coverage gap is currently required to subsidize 50% of the “negotiated price” of the drug – that is, the amount the Part D plan has agreed to pay the pharmacy for the drug. The enrollee and the plan share the remainder of the cost. Before BBA 2018, the enrollee’s cost-sharing amount in the coverage gap, 35% in 2018, was to decrease to 30% in 2019 and 25% in 2020 and thereafter. BBA 2018 has accelerated that reduction so that enrollees will pay 25% in 2019 and thereafter. At the same time, BBA 2018 increased the manufacturer’s subsidy under the Coverage Gap Discount Program from 50% to 70% of the negotiated price, beginning in 2019. (Drugs approved under ANDAs are unaffected by this amendment, since they are not subject to coverage gap discounts.)

Biosimilars no longer exempt from coverage gap discounts (BBA 2018 section 53113): Before BBA 2018, biosimilars were exempt from coverage gap discounts. That exemption will now terminate beginning in 2019.

Correction of alternative rebate for line extensions under Medicaid Drug Rebate Program (BBA section 53104): Under the Medicaid Drug Rebate Program, a line extension (for example, an extended release formulation) of an oral solid dosage form innovator drug is subject to an alternative unit rebate amount (URA) calculation, if that calculation produces a URA higher than that produced under the ordinary statutory methodology. The alternative calculation was intended to tie the URA of the line extension drug to the degree of the original drug’s price increases, in order to prevent manufacturers from avoiding price increase penalties by making small changes in a line extension. However, the alternative calculation formula, enacted in 2010 as part of the Affordable Care Act, did not work as intended, and has now been corrected by BBA 2018.

Before BBA 2018, the alternative URA calculation took the highest additional rebate (i.e., the penalty rebate for price increases greater than inflation) of any strength of the original drug as a percentage of the original drug’s average manufacturer price (AMP), and multiplied that amount by the AMP of the line extension drug. Under the BBA 2018 amendment, an amount is calculated as described above, but that amount is added to the base rebate (usually 23.1% of the AMP) of the line extension drug. Therefore, the alternative URA calculation will be greater under the BBA 2018 revision than under the original provision. The new amendment is effective as of October 1, 2018. Note that CMS has yet to issue regulations defining a “line extension” – something the agency said two years ago that it intends to do.

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Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day Workshop

Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day Workshop

By Véronique Li * & Jeffrey K. Shapiro

The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and effective digital health products. One step in the plan is developing a Digital Health Software Precertification (Pre-Cert) Program. We blogged on the overall digital health plan here.

As part of developing the Pre‑Cert Program, Dr. Jeff Shuren, Center Director of CDRH, welcomed the audience to a two day workshop at the end of January. Bakul Patel, Associate Director for Digital Health, introduced the program in detail, summarizing its progress to date and sharing lessons learned. The workshop was divided into five panels with opportunities for the audience to ask questions on the first day and three breakout sessions with time to share breakout discussions with the larger group on the second day.

The panels included representatives from among Pre-Cert pilot participants, CDRH Pre-Cert team members (many of whom doubled as workshop moderators), patients, payers, providers, investors, assessors, trade associations, and academic institutions.

The Pre-Cert Program has been touted as an organization-based streamlined regulatory approach for Software as a Medical Device (SaMD) that relies on a demonstrated Culture of Quality and Organizational Excellence (CQOE), where SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. The excellence principles are:

  1. Patient Safety
  2. Product Quality
  3. Clinical Responsibility
  4. Cybersecurity Responsibility
  5. Proactive Culture.

One of the overarching workshop themes was that FDA intends to work closely with stakeholders to develop the Pre-Cert Program. The idea is CDRH could “precertify” companies that exhibit CQOE, based on objective criteria. These organizations would qualify to market their lower-risk devices without additional FDA review or with a more efficient premarket review (depending on the product).  This focus on the manufacturer, and not the product, would be a significant departure from the Agency’s historical approach to premarket product review.

The following were interesting or notable aspects of the discussion:

The notion of using CQOE principles for evaluation of software firms was received well, but a lot of questions were raised about what metrics, as a practical matter, would be suitable. There was also a question about how frequently companies would need to re-certify. The moderators also asked participants to consider what the certification review would look like and emphasized that it needed to be feasible for both small and large organizations and align with how software firms conduct themselves.

No consensus answers emerged. True to form for a technological crowd, some panelists suggested crowdsourcing to identify key performance indicators (KPIs metrics).  The crowdsourcing approach was also suggested for collecting real world data from users on product performance, which would then be shared with developers, who would use this feedback to improve safety and effectiveness in the next software version. This iterative life‑cycle approach has the potential to tie in nicely with the Center’s efforts to promote the National Evaluation System for health Technology (NEST), which is being developed to generate better evidence for medical device evaluation across the total product lifecycle and regulatory decision-making.

We learned that the nine pilot participants each had hosted CDRH for a two-day site visit. The visits were the first steps from CDRH to engage stakeholders. Representing small and large organizations, profit and non-profit, the participants agreed on ensuring high‑quality products reached market sooner and promoting a concept of transparency to ensure confidence and credibility of both the program and its participants.

During these visits, CDRH and the pilot participants had discussed common organizational traits such as having agile processes and a culture that recognizes and supports efforts to ensure quality, but also recognized the difficulty in aligning the five excellence principles with the four validating perspectives (i.e., organizational resource, customer, learning and growth, and process). Another outcome of these interactions was that FDA postulated that a library of KPIs could be used to determine a CQOE, acknowledging that no one set would fit every company.

The panels at the workshop provided interesting perspectives on how a precertification program would be understood and received by their communities. For instance, one panelist from the healthcare stakeholder perspectives panel noted the need for clarification between software reviewed under a product based pathway such as the 510(k) versus software considered under a firm based approach as imagined in the Pre-Cert. She also noted that payers will have to consider reimbursement of apps judiciously. The reimbursement process will take time and could frustrate software developers.

Another panelist from the same group pointed out that healthcare is moving towards a value based system that considers clinical outcomes. He expressed concern about constantly evolving algorithms in software and the potential disruption to clinical workflow. The same panelist wondered how a clinician would obtain information to help choose one company’s software over another.

Another panelist brought up recent experience with electronic health records (EHR). The EHR implementation included cybersecurity, lost data, power failure, and interoperability issues. These same issues could begin to plague digital health software.

A panelist challenged the notion that digital health should be subject to traditional processes. He cited the tradeoffs patients are willing to make in exchange for faster access to technology and highlighted the challenges of costly, time‑consuming clinical studies which could lag well behind innovation.

In general, there was much spirited discussion that showed there is still a long way to go in standing up the Pre-Cert program, something the CDRH moderators acknowledged as well. The good news is that CDRH clearly is interested in developing the Pre‑Cert program with input from the community.

It seems to us that the key issue is the KPI metrics that will be used to assess companies. It is easy to sketch out the broad CQOE principles.  Figuring out how to operationalize these principles with concrete KPI metrics is much harder.  Some of the metrics that were introduced and discussed during breakout sessions included employee performance, customer engagement, and brand reputation. However, even these metrics are fairly abstract and hard to measure.  One wonders how “brand reputation” would even apply to smaller start ups.  All in all, it is probably fair to say that the workshop shed light on how difficult it will be to adopt a binding list of KPI metrics and how far off those decisions are.

CDRH has invited those who are willing to share their thoughts on the Pre-Cert Program, whether it be in the form of questions or requests for clarification, to do so in an email to or through a comment on the open docket entitled “Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program”.

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FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

FDLI’s New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

By Hyman, Phelps & McNamara, P.C.

On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus:  MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be moderating the webinar.

As the title of the webinar suggests, several important pieces of FDA legislation have recently been enacted that significantly affect the medical device industry.  FDA has been busy implementing the new laws, issuing numerous final and draft guidance documents and policies.  These developments directly affect device companies:

  • Implementing changes in device inspections to make them more risk-based
  • Establishing pilots for the use of Real World Evidence
  • Issuing new checklists for de novo submissions
  • Evolving approaches for patient preference information
  • Developing guidance in the digital health space
  • Streamlining MDR reporting, and more

Keeping up with the array of changes and proposed changes is challenging.  Join a panel of industry and agency experts for a status update on what’s happened already, what’s coming, and where medical device companies should be focusing their efforts.

You can register here for the webinar.

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CDRH Publishes Metrics for Third-Party 510(k) Reviews

CDRH Publishes Metrics for Third-Party 510(k) Reviews

By Allyson B. Mullen

The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants.  On January 26, 2018, FDA took its first step towards complying with the new requirements when it issued performance metrics for third-party reviewers (available here).

As discussed in our FDARA summary (available here), the types of devices has been modified. Addressing the restrictive aspect, the most significant change was that devices requiring clinical data are no longer excluded from eligibility for the program.  This change has opened up the possibility of more devices, most notably IVDs, being able to undergo third-party review in the future.

FDA will issue a draft guidance regarding the factors it will use to determine whether a Class I or II device is eligible for third-party review, and the Agency will finalize the guidance within 24 months from issuance of the draft. On the same day the guidance is finalized, FDA will also publish a list of Class I and II devices eligible for third-party review. Until this new list is published, the current list of devices eligible for third-party review is still in effect. In addition, as part of the user fee negotiations, FDA agreed, by the end of 2018, to issue draft guidance regarding criteria for reaccreditation of third party reviewers and the suspension or withdrawal of accreditation of a third party.

Finally, FDA agreed to publish performance metrics regarding third-party reviewers with at least five completed submissions on the web. FDA’s published statistics for FY2018 only, meaning, at most, less than four months worth of data.  There were seven third party reviewers totaling 18 510(k) submissions since October 1, 2017.  Only one of the reviewers had more than five submissions during this timeframe.  This report was issued on January 26, but it is not clear when data collection for the report ceased.  This sparse data set is of little to no use.  Presumably, the next data set will be more meaningful.

The user fee commitment did not specify a timeframe for analysis. It seems odd that FDA selected FY2018.  It provides very limited information because it is such a short time frame.  The utility of the report is, accordingly, limited.  We look forward to FDA completing its other required tasks related to the third party review process.  The process certainly holds potential but has been consistent in one respect – during its two decades, it has not lived up to its expectations or potential.  Perhaps these steps will help change that.

REMINDER: Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability! (Sign up here.)

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FDA Publishes First Installment of Guidance Regarding Preventive Controls Requirement for Animal Food

FDA Publishes First Installment of Guidance Regarding Preventive Controls Requirement for Animal Food

By Riëtte van Laack

On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (PC rule). Subpart C contains the requirements for facilities to use when developing a written animal food safety plan, conducting a hazard analysis and implementing risk-based preventive controls, if needed.

The draft guidance includes five chapters:

  • food safety plan requirements;
  • recommendations for conducting a hazard analysis;
  • hazards associated with the manufacturing, processing, packing and holding of animal food;
  • examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
  • preventive control management components.

In the federal register notice, CVM identifies them as the first five chapters suggesting that more will be added at a later time.

Similar to what FDA did in the draft guidance for human food preventive controls, CVM prepared a list of different animal food ingredients with specific references to hazards. Although this listing of hazards may seem helpful, it does have disadvantages and seems somewhat inconsistent with the PC rule.  Inspectors can be expected to use the list to determine whether a company has included the listed hazards listed in it’s hazard evaluation.  This appears inconsistent with the requirement that a company must conduct its own analysis based on the scientific literature, personal experience, illness data, etc.  We also note that the list of hazards for various ingredients appears to be based on data going back to 1989 – almost thirty years ago.  Query to what extent thirty year old data are relevant.

The timing of the draft guidance is somewhat unfortunate, because the compliance date for all businesses except those that are small or very small has already passed. FDA published final rules to implement the hazard analysis and risk-based preventive control (PC) provisions for human and animal food on September 17, 2015.  Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions as of September 18, 2017.  (Small businesses need to comply by no later than September 17, 2018, and very small businesses need to comply with limited provisions by September 17, 2019.)  FDA announced last year in August that it planned to delay routine preventive controls inspections for large businesses until fall 2018.  However, at that time the Agency made clear that this delay in inspections did not mean that companies should wait with the development of their food safety plan.  In the absence of CVM guidance, those food safety plans may not include or have considered hazards that CVM now has identified.  It remains to be seen how CVM will use its own guidance and whether it will rely on the hazards identified in this draft guidance.

Comments to the draft guidance are due by July 23, 2018.

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USDA and FDA Announce Intent to Improve and Increase Coordination and Collaboration

USDA and FDA Announce Intent to Improve and Increase Coordination and Collaboration

By Riëtte van Laack

Thanks On January 30, 2018, Dr. Gottlieb of FDA and Secretary Perdue of the USDA announced that they had signed a formal agreement to make the coordination and collaboration between the two agencies more efficient and effective.

The USDA has jurisdiction over most meat, poultry, catfish, and certain egg products whereas FDA has jurisdiction over all other foods such as dairy, seafood, produce and packaged foods. Over the years, the two agencies have worked together and made agreements about information sharing, e.g., a Memorandum of Understanding (MOU) from 1999 concerning information sharing about establishments and operations that are subject to dual jurisdiction and an MOU from 2000 concerning review of ingredients intended for use in products under USDA jurisdiction.

The purpose of the January 30, 2018 formal agreement is to “document and formalize ongoing coordination and collaborative efforts between the USDA and the FDA relative to issues of shared concern.” The agreement specifically calls out the issues of dual-jurisdiction facilities, produce safety, and the regulation of biotechnology products.  As far as dual jurisdiction facilities are concerned, “USDA and FDA share the goals of identifying and potentially reducing the number of establishments subject to the dual regulatory requirements of USDA and FDA, bringing greater clarity and consistency to jurisdictional decisions under USDA and FDA’s respective authorities, including transition period, and decreasing unnecessary regulatory burdens.”  Although this likely comes as good news for such facilities, the agreement seems a statement of intent and does not provide details as to how the agencies anticipate accomplishing their goals.

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Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!

Join Us in April to Learn More about Improving Regulatory Compliance While Minimizing Products Liability!

By Hyman, Phelps & McNamara, P.C.

The fact is, regulatory compliance has an impact on products liability.  Yet, the two are seldom considered together.

We aim to change that with a special day and a half program (April 12th and 13th).  Our FDA regulatory firm has teamed up with a renowned medical device liability insurer, MEDMARC Insurance, for a joint program.  It will be held at Virginia Tech’s state-of-the-art conference facility in Arlington, Virginia.

Based upon years of claims experience, MEDMARC has identified the specific FDA regulatory areas that pose the most products liability danger.  We will teach you about improving regulatory compliance in those areas.  MEDMARC will help you understand how to reduce products liability risks.  The combination of these two topics creates a synergy that adds up to powerful risk management.

So give yourself a competitive advantage!  Learn the ounce of prevention that will save you many tens of thousands of dollars every time your FDA inspection goes right or a costly products liability lawsuit is prevented.

All the key program details are in the conference brochure.  You can register here for the conference.

We can’t wait to see you this April to share what we know about mitigating the “other risks” associated with government regulation.

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