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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Another Request for a Stay and Reconsideration of the Final Nutrition Labeling Rule

Another Request for a Stay and Reconsideration of the Final Nutrition Labeling Rule

By Riëtte van Laack –
As readers of this blog know, in May 2016, FDA issued a final rule amending the nutrition labeling regulations for food and dietary supplements. Major amendments include a new requirement to declare “added sugar,” the setting of a daily value for added sugars (but not for total sugars), and a new definition of dietary fiber (see our previous post here).
FDA has received at least two Citizen Petitions requesting a stay of the rule and reconsideration (or withdrawal) of the definition of dietary fiber. Last week, the Agency announced that it will extend the compliance date to provide companies with guidance regarding the final rule (see our previous post here).
FDA’s proposal to require added sugars may be the most controversial issue and generated many comments. However, besides comments to a draft guidance addressing added sugars and comments and questions in other contexts, no party had so far formally objected to the new requirement to declare added sugars. That changed on June 20, 2017, when the Natural Products Association (NPA) submitted a Citizen Petition asking FDA for a stay and reconsideration of the final rule. NPA’s Petition focuses on the rule’s requirements for added sugar but also addresses the dietary fiber definition.
The Petition identifies seven grounds for a stay and reconsideration, five of which focus on the requirement to declare added sugars. Grounds include FDA’s alleged failure to comply with rulemaking procedures of the Administrative Procedures Act and the new administration’s regulatory agenda and directives. Petitioner also asserts that the final rule requiring declaration of added sugars raises First Amendment concerns because it imposes unjustified and unduly burdensome disclosure requirements on companies. NPA also finds fault with FDA’s analyses and conclusions based on consumer and eye tracking studies.
With respect to the dietary fiber definition, Petitioner alleges that all non-digestible carbohydrates have a physiological effect by virtue of being non-digestible and thereby “promoting an osmotic and bulk laxative physiological effect.” In somewhat caustic terms, Petitioner challenges FDA to show that a non-digestible carbohydrate does not have such a beneficial effect.
Thus far, FDA has not given any indication that it will reconsider the final rule. We will be monitoring new developments.

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A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access

A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access

By Sara W. Koblitz – 
On June 21st, FDA announced an all-day public meeting dedicated to the Hatch-Waxman Amendments that will take place on July 18, 2017. The meeting, titled “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he indicated was forthcoming during a May 2017 House Appropriations Committee hearing.  The meeting is intended to further explore the juxtaposition of innovation in drug development and access to lower cost alternatives to innovator drugs. In an FDA Voice blog post, Commissioner Gottlieb explains that FDA is looking at how regulatory rules might be “gamed” or misused to reduce competition, keeping prices high for consumers. FDA is also bringing in the anticompetitive experts at the FTC to help out.
FDA posed several questions for stakeholder input:

How have exclusivity periods, patents and patent listing procedures, innovator drug product labeling, post-approval changes to innovator products, and other regulatory processes (such as the citizen petition process) impacted the balance of innovation and access set forth in the Hatch Waxman Amendments?

Given that many ANDAs are never marketed or subject to substantial delays after approval, what marketplace dynamics dis-incentivize the marketing of approved generics? What can FDA do to help approved generics come to market?

Why are there so many drugs that have lost patent and exclusivity protection but have no generic competition? Are there areas where Hatch-Waxman Amendment incentives are insufficient to develop a generic?

How should FDA use its authority to waive shared REMS systems to avoid delay or should it develop other administrative tools to do so?

What should FDA do to promote access to testing samples?

What other elements of drug product development, regulation, and marketing have the potential to disrupt the Hatch-Waxman Amendments’ balance between innovation and generic availability, and how should the Agency address them?

Written comments are due by September 18, 2017. Registration for the public meeting, as well as requests to make oral presentations, is due to FDA by July 3, 2017. We’re sure we’ll see you all at what promises to be an exciting meeting!

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FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance

FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance

By Kurt R. Karst –
Although both the U.S. House of Representatives and U.S. Senate are still in the midst of considering legislation – the FDA Reauthorization Act of 2017 (“FDARA”) (H.R. 2430 and S. 934) – to, among other things, reauthorize an alphabet soup of user fee programs, including the second iteration of the Generic Drug User Fee Amendments (“GDUFA II”), and as the Congressional Budget Office analyzes the cost of FDARA (see here), FDA has apparently decided that it’s pretty certain that GDUFA will ultimately be enacted into law. Earlier this week, FDA issued a draft guidance document, titled “ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions,” that is intended to implement a new Pre-Submission Facility Correspondence (“PFC”) process for certain ANDA sponsors. 
As part of GDUFA II, FDA and the generic drug industry hammered out a Commitment Letter under which FDA agreed to review and act on certain “priority ANDAs” (including original ANDAs, ANDA amendments, and ANDA Prior Approval Supplements) within timeframes shorter than those established for “standard ANDAs.” For example, while FDA agreed to review and act on 90% of standard original ANDAs within 10 months of the date of ANDA submission, 90% of priority original ANDAs will be reviewed and acted on “within 8 months of the date of ANDA submission, if the applicant submits a Pre-Submission Facility Correspondence 2 months prior to the date of ANDA submission and the Pre-Submission Facility Correspondence is found to be complete and accurate and remains unchanged.” If, however, “the applicant does not submit a Pre-Submission Facility Correspondence 2 months prior to the date of ANDA submission or facility information Changes or is found to be incomplete or inaccurate,” then FDA will review and act on 90% of priority original ANDAs within 10 months of the date of ANDA submission.  Whether a particular ANDA submission qualifies for “priority” status will depend on the sponsor meeting the criteria laid out in FDA’s “Prioritization MAPP” (i.e., Manual of Policies and 35 Procedures (MAPP) 5240.3, Rev. 2, “Prioritization of the Review of Original ANDAs, Amendments, and Supplements”).
As described above, the PFC process is the linchpin to obtaining an 8-month priority review goal date. And as we approach the beginning of Fiscal Year 2018 when GDUFA II is expected to go into effect, FDA wants to make the PFC process as clear as possible now so that ANDA sponsors can begin putting together the necessary paperwork to submit requests in anticipation of the GDUFA II goals becoming reality.  To that end, the draft guidance “establishes FDA’s expectations for the content, timing, and assessment of the PFC,” and, specifically defines:

The content and format of the information that should be submitted in the PFC to enable FDA’s assessment of facilities listed in the PFC.
PFC timeframes and their intersection with the subsequent ANDA submissions.
The possible outcomes of the Agency’s assessment of the PFC.
When and how the PFC submitter is notified by the Agency about the status of the PFC.

The draft guidance lays out a detailed set of instructions for ANDA sponsors to follow when making a PFC submission. And knowing FDA’s (the Office of Generic Drug’s) penchant for kicking out or refusing submissions that don’t meet even the smallest detail, ANDA sponsors would be wise to ensure that every “i” is dotted and every “t” is crossed in a PFC submission.
Timing is also a critical component of the new PFC process, because PFCs have a short expiry date. The GDUFA II Commitment Letter provides that a PFC should be submitted to FDA two months ahead of the planned ANDA submission date in order for an application to be eligible to receive the shorter 8-month goal date.  According to FDA:

[I]f the time elapsed between submission of the PFC and submission of the planned ANDA is too long, it is less likely that facility information will remain unchanged, as defined by the GDUFA II Commitment Letter. Thus, FDA’s PFC facility assessment may become out-of-date and need to be repeated after the planned ANDA is submitted, eliminating the benefit of the PFC submission to both FDA and the applicant.  Therefore, this guidance establishes a window of time between 2 and 3 months after PFC submission during which applicants should submit their planned ANDA. 

This is referred to in the draft guidance as the “ANDA Submission Window.” For example, if a PFC is submitted to FDA on December 1st, then the planned ANDA should be submitted to FDA between February 1st and March 1st.  Similarly, if the PFC is submitted to FDA on December 31st, then the planned ANDA should be submitted to FDA between February 28th (in a non-leap year) and March 31st. 

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Nevada Transparency Bill Targets Diabetes Drugs and Payments to Health Care Providers

Nevada Transparency Bill Targets Diabetes Drugs and Payments to Health Care Providers

By David C. Gibbons & Alan M. Kirschenbaum –
Nevada has become the most recent state to enact a law addressing drug prices. S.B. 539, enacted on June 15, 2017, places new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider (“HCP”) payments. Patient advocacy groups are also required to report certain payments from pharmaceutical manufacturers, PBMs, and other third parties.
Manufacturer Reports
S.B. 539 requires the Nevada Department of Health and Human Services (“NDHHS”) to compile a list of prescription drugs that it determines are “essential for treating diabetes” in Nevada, along with the wholesale acquisition cost (“WAC”) of each drug on the list (“List #1”). NDHHS must then list the subset of those drugs whose WAC has increased by a percentage equal to or greater than either the Consumer Price Index, Medical Care Component (“CPI Medical”) during the preceding calendar year or twice the CPI Medical during the preceding two years (“List #2”).
Every year, on or before April 1, manufacturers whose drugs appear on List #1 are required to report to NDHHS the following information regarding such drugs:

Costs of producing the drug;
Total administrative expenditures relating to the drug, including marketing and advertising costs;
Profit earned by the manufacturer from the drug and the percentage of total profit for the period attributable to the drug; 
Total amount of financial assistance provided by the manufacturer through any patient assistance program;
Cost associated with coupons provided directly to consumers and for copayment assistance programs, along with the cost to the manufacturer attributable to the coupons and copay programs;
The drug’s WAC;
History of WAC increases over the preceding five years, including the amount of each such increase expressed as a percentage of the total WAC, the month and year in which each increase became effective, and any explanation for the increase;
Aggregate amount of all PBM rebates provided by the manufacturer for sales of the drug in Nevada; and
Any additional information prescribed by NDHHS regulation.

In addition, manufacturers whose drugs appear on List #2 are required to report each factor that contributed to the increase in WAC along with the percentage of the increase attributable to each factor, the role played by each factor in the WAC increase, and any other information prescribed by NDHHS regulation.
Sales Representative Reports
All pharmaceutical manufacturers are required to provide NDHHS with an annually updated list of sales representatives who market the manufacturer’s prescription drugs to Nevada-licensed, -certified, or -registered HCPs, pharmacies, medical facilities, or individuals licensed or certified under the Nevada insurance code (“enumerated HCPs”). NDHHS will then provide access to this list to all enumerated HCPs. A sales representative not on the list is prohibited from marketing prescription drugs to enumerated HCPs. Sales representatives who are on the list and permitted to market prescription drugs in Nevada must provide a list to NDHHS of all enumerated HCPs that were provided with any type of compensation exceeding $10 in individual value or $100 in aggregate value. These sales representatives are also required to report information concerning free prescription drug samples, including the name of each enumerated HCP to whom a free drug sample was provided. The provisions pertaining to sales representatives are not limited to diabetes drugs.
PBM Reports
PBMs are required to submit annual reports to NDHHS on or before April 1 that include the following:

The total amount of all rebates negotiated by the PBM with manufacturers during the preceding calendar year for drugs included on List #1;
The total amount of such rebates retained by the PBM; and
The total amount of such rebates negotiated for purchases of such drugs for use by:

Medicare beneficiaries;
Medicaid beneficiaries;
Beneficiaries of third party plans provided by governmental entities (but not Medicare or Medicaid);
Beneficiaries of third party plans not provided by governmental entities; and
Beneficiaries of certain plans subject to the Employee Retirement Income Security Act of 1974 (“ERISA”).

Nonprofit Organization Reports
Finally, nonprofit organizations that advocate on behalf of patients or that fund medical research in Nevada and receive a “payment, donation, subsidy, or anything else of value” from either a pharmaceutical manufacturer, PBM, or other third party, or a trade or advocacy group for the same, must compile a report on or before February 1 of each year. The report must detail the amount and source of each payment and the percentage of the total gross income of the organization during the immediately preceding calendar year attributable to such payment(s). These reports must either be posted on the nonprofit’s own publicly-accessible website or submitted to NDHHS if the nonprofit does not maintain such a website.
Penalties
S.B. 539 imposes administrative penalties for noncompliance with its provisions. Pharmaceutical manufacturers, PBMs, or nonprofit organizations that fail to provide the required reports described above may be subject to administrative penalties of not more that $5,000 per day unless such failure to timely comply with the requirements is due to “excusable neglect, technical problems, or other extenuating circumstances.” Pharmaceutical sales representatives who do not timely submit required reports may be subject to administrative penalties of not more than $500 per day.
Disclosure of Reported Information
S.B. 539 mandates that NDHHS compile a report on the information it receives pursuant to the requirements described above and make such information publicly available. First, the NDHHS must place “on the Internet website maintained by [NDHHS]” its report comprising the information on List #1. Second, NDHHS must compile a report based on its analysis of information provided by manufacturers regarding their drugs on Lists #1 and #2 and from PBMs regarding rebates. Third, NDHHS is also required to analyze and prepare a report on the information reported by sales representatives; however, the identity of individual sales representatives or the entities they represent may not be disclosed and only reported in aggregate. Finally, NDHHS must place information reported by nonprofit organizations on its website for those nonprofits who submit reports to NDHHS because they do not maintain a website of their own.
Conclusion
With this statute, Nevada joins the growing list of states seeking to limit pharmaceutical costs and marketing activities through legislation requiring reporting, pricing restrictions, and/or marketing prohibitions. Reporting and/or prohibitions on manufacturer payments to practitioners and providers have long existed in Connecticut, DC, Minnesota, Massachusetts, and Vermont. More recently, state focus has shifted from drug marketing activities to drug prices, with New York, Maryland, and Vermont enacting requirements for reporting or outright restrictions on price increases on certain drugs. The Nevada reporting law encompasses both payments to practitioners and price increases (though the latter is limited to diabetes drugs), and adds PBM and patient advocacy organization transparency requirements. Though numerous bills addressing drug prices have been introduced in Congress (mostly by Democrats) and the Trump Administration has objected to high drug prices and held stakeholder meetings on the subject, these initiatives appear unlikely to produce any hard results in the near future. In the absence of federal action, states are clearly taking the lead, with 30 states considering over 150 bills on pharmaceutical pricing and payments (see data available at the National Conference of State Legislatures here). We will be following these state activities closely.

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FDA: Protecting the Integrity of Horse Racing Since 1906

FDA: Protecting the Integrity of Horse Racing Since 1906

By Andrew J. Hull –
Our postings on the FDC Act typically focus on more straightforward applications of FDA’s regulation of the food and drug world. Drug development, patent dances, off-label promotion prosecutions, newly defined menu labeling—these are some of the many issues we associate with FDA’s activities.
But since the passage of the Food and Drugs Act of 1906 (the predecessor to the modern FDC Act), FDA has asserted its statutory and regulatory authority in a number of unexpected/unique circumstances.
The most recent example: the prosecution of a racehorse doping scandal in Pennsylvania.
FDA’s Office of Criminal Investigation has investigated and been involved in the prosecution of Murray Rojas, a veteran horse trainer and non-veterinarian, who was indicted on allegations that, inter alia, from 2002 through 2014, she directed the administering of prohibited substances to the horses she trained prior to over forty separate horse races at the Penn National Race Course in Grantville, Pennsylvania (just outside of Harrisburg) (see OCI’s press release announcing the indictment here).
The indictment, filed in the U.S. District Court for the Middle District of Pennsylvania, charges the defendant with felony misbranding under the FDC Act, claiming that the defendant misbranded the drugs with intent to defraud or mislead, in violation of 21 U.S.C. §§ 331(k), 333(a)(2), and 353(f)(1)(C). Specifically, 21 U.S.C. § 353(f)(1)(C) states that the dispensing of an animal drug that must be administered under the professional supervision of a licensed veterinarian (i.e., a prescription drug) constitutes the misbranding of a drug if it is not “dispensed by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by the person filling the order. Id. § 353(f)(1)(B).
The defendant brought a motion to dismiss these counts, arguing that a violation of 21 U.S.C. § 353(f)(1)(C) can only occur if an unlicensed veterinarian or non-veterinarian administers the drugs to an animal. Because the individuals who allegedly acted under the defendant’s direction were licensed veterinarians, the defendant contended that these counts were legally deficient.
In a recent decision, the court denied the motion to dismiss the indictment counts involving the criminal misbranding of animal drugs. Specifically, the court held that the indictment sufficiently alleged misbranding and conspiracy to misbrand. In doing so, the court reasoned that 21 U.S.C. § 353(f)(1) requires that the administration of a prescription drug to an animal must be done pursuant to either a prescription or some other lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice. It is not sufficient that the individual administering the prescription drugs be a veterinarian in order to avoid criminal misbranding liability under the FDC Act. The court observed that the indictment sufficiently alleged a violation. The court’s ruling was not a finding that any violation had occurred. The court noted: “It will be for the factfinder to determine at trial whether the licensed veterinarians dispensed any prohibited substances to horses in contravention of Pennsylvania law, and if so, whether they were acting lawfully in accordance with their professional practices or merely at the behest of Defendant during such administration.”
The trial and jury selection is scheduled to start on June 19, 2017.

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Supreme Court Ruling on SEC Statute of Limitations May Affect Other Agencies’ Pursuit of Disgorgement

Supreme Court Ruling on SEC Statute of Limitations May Affect Other Agencies’ Pursuit of Disgorgement

By Jennifer M. Thomas & Gugan Kaur –
On June 5th, 2017, the U.S. Supreme Court issued its opinion in Kokesh v. Securities and Exchange Commission. The Court unanimously reversed the Tenth Circuit’s decision below, and ruled that a five-year statute of limitations for the enforcement of “any civil fine, penalty, or forfeiture” (28 U.S.C. § 2462) applied to the SEC’s claims against Kokesh seeking disgorgement.
Importantly, in reaching its decision in Kokesh the Court found that SEC disgorgement (which requires a defendant to pay back any gains attributable to the wrongful conduct) operates as a penalty under 28 U.S.C. § 2462. The Court also stated that it had not reached the question of “whether courts possess authority to order disgorgement in SEC enforcement proceedings or on whether courts have properly applied disgorgement principles in this context.” (Slip. Op. at 5 n. 3). The Court’s classification of disgorgement as a penalty, and its dicta on the question of whether disgorgement is appropriate under the Securities Exchange Act, has the potential to affect other agencies’ pursuit of disgorgement in enforcement actions.
Like the Securities Exchange Act of 1934 (15 U.S.C. § 78a et seq.) at issue in Kokesh, neither the Food, Drug, and Cosmetic Act (“FDC Act”) nor the Federal Trade Commission Act (“FTC Act”) explicitly authorize disgorgement. Rather, the government has asserted disgorgement authority inherent in FDC Act Sec. 302(a), which awards district courts jurisdiction to restrain most violations of the FDC Act (21 U.S.C. § 332(a)), and Section 13(b) of the FTC Act, which authorizes the FTC to seek preliminary and permanent injunctions to remedy “. . . any provision of law enforced by the Federal Trade Commission….” (15 U.S.C. § 53(b)).
Courts have upheld FDA’s and the FTC’s efforts to seek restitution or disgorgement as a remedy. See, e.g., United States v. Universal Mgmt. Servs., 191 F.3d 750, 763-63 (6th Cir. 1999) (reasoning that both disgorgement and restitution are appropriate under the FDC Act); FTC v. Cardinal Health, No. 15-cv-3031(S.D.N.Y Apr. 20, 2015); FTC v. Gem Merchandising Corp., 87 F.3d 466, 470 (11th Cir. 1996). Disgorgement has become an important enforcement tool for FDA, in particular, although we previously questioned whether remedies such as restitution and disgorgement are appropriate under the FDC Act. See Jeffrey N. Gibbs, John R. Fleder, Can FDA Seek Restitution or Disgorgement?, 58 Food and Drug L. J. 129-47 (2003).
After Kokesh, the government may have more to consider when determining whether to seek disgorgement under the FDC Act or FTC Act. The fact that the Supreme Court declined to address whether disgorgement principles are “properly applied” under the Securities and Exchange Act will likely be cited by defendants in arguing that disgorgement is inappropriate under the other Acts that do not specifically provide for that remedy. Also in light of this new precedent, the Department of Justice may have to reanalyze the question of whether a penalty of disgorgement raises double jeopardy concerns if the government seeks to later bring a criminal prosecution relating to the same conduct. See Application of the Double Jeopardy Clause to Disgorgement Orders Under the Federal Trade Commission Act (Apr. 9, 1998).  On this point, defendants will undoubtedly rely on the Court’s reasoning in Kokesh to argue that disgorgement is so punitive in nature as to qualify as a criminal penalty that should bar later criminal proceedings. Finally, Kokesh has the ancillary consequence of calling into (further) question whether disgorgement payments are tax deductible, an issue that we have previously addressed here. See Internal Revenue Code Sec. 162(f) (fines or penalties are nondeductible); see also IRS OCC Memorandum (Jan. 29, 2016), (disgorgement payments are nondeductible if they are primarily punitive). This is something that both the government and defendants will need to consider with respect to any settlement of an enforcement action that involves disgorgement.

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FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations

FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations

By Riëtte van Laack & Etan Yeshua –
As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance date, FDA published an interim final rule (IFR) that delayed compliance for one year and solicited comments on how the Agency can “further reduce the regulatory burden or increase flexibility.”
On June 7, two consumer advocacy organizations sued FDA to have the IFR vacated and a more immediate compliance date instated. The Center for Science in the Public Interest and the National Consumer League (the plaintiffs) claim that FDA’s delay of the menu labeling rule was illegal because it did not “rationally explain[] why it was changing its interpretation of” the federal requirements, and because it did not provide an opportunity for public notice and comment before the delay took effect.
First, the plaintiffs allege that FDA’s decision to delay the compliance date violated the Administrative Procedure Act (APA) by “departing from its prior interpretation of the [Affordable Care Act] and its prior conclusions about the importance of nutrition labeling without providing a rational explanation.” (The Affordable Care Act was the statutory basis for the menu labeling requirements.) They point to FDA’s own Regulatory Impact Analysis for the IFR – where the Agency assesses the costs and benefits of delaying the compliance date – to support the claim that FDA did not provide a rational explanation for the delay: the Agency’s analysis concludes that the costs of the delay in terms of reduction in benefits to the consumer ($5 million to $19 million) outweigh the benefits to industry ($2 million to $8 million). The plaintiffs also quote a spokesperson for the National Restaurant Association as opposing the delay.
Second, the plaintiffs allege that FDA was not permitted to issue the IFR without providing an opportunity for public comment. Under the APA, an agency may forego notice and comment rulemaking and issue an IFR with an immediate effective date only when it has “good cause,” i.e., when it determines that it would be “impracticable, unnecessary, or contrary to the public interest” to follow the notice and comment procedures. The plaintiffs assert that FDA did not have the required good cause: they cite FDA’s preamble to the final menu labeling regulations, which states that the rule “provides flexibility where appropriate” by “accommodat[ing] different types of menus and menu boards and the various ways that standard menu items may be listed on menus and menu boards.”
The plaintiffs request that the court declare the IFR “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law, and to have been published without observance of legally required procedure, in violation of the APA.” They further request that the court issue an order vacating the IFR and set a compliance date for the final menu labeling rule that is within 15 days of the court’s order.

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FDA Announces Intent to Extend Compliance Date for Nutrition Labeling

FDA Announces Intent to Extend Compliance Date for Nutrition Labeling

By Riëtte van Laack –
On June 13th, FDA’s Office of Nutrition and Food Labeling “announced” that it intends to extend the compliance date for the new Nutrition Facts requirements.  As we previously reported, FDA received several citizen petitions requesting an extension of the compliance date. In addition, some in the industry had sought to delay the compliance date to coincide with the regulations (yet to be developed) for GMO (Genetically Modified Organism) labeling. Although the announcement may not have been a surprise, the way it was delivered was highly unusual. There was no press release or Federal Register announcement. Instead the “announcement” was included on the webpage on Changes to the Nutrition Facts Label.
FDA states that, based on feedback from industry and consumer groups regarding the compliance date, the Agency “determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.”  FDA’s announcement is limited as it only states FDA’s intent to extend the compliance date. How long the compliance date will be extended and whether FDA also will reconsider certain aspects of the regulation (e.g., the dietary fiber definition) are unknown. FDA will provide details on the extension through a Federal Register Notice at a later time.
We will blog more as further information becomes available.

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U.S. Supreme Court Rules in Amgen v. Sandoz; Gives a Potential Boost to the Biosimilars Industry

U.S. Supreme Court Rules in Amgen v. Sandoz; Gives a Potential Boost to the Biosimilars Industry

By Sara W. Koblitz –
In a relatively infrequent unanimous decision, the U.S. Supreme Court this morning (June 12th) interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) such that the biosimilar patent dance is not mandatory. As regular readers of the FDA Law Blog know, Amgen sued Sandoz for failure to engage in the patent dance and inadequate notice of commercial marketing for Sandoz’s ZARXIO (filgrastim-sndz), a biosimilar version of Amgen’s NEUPOGEN (filgrastim). Amgen sought injunctions to enforce the BPCIA patent dance requirements and for patent infringement while Sandoz counterclaimed for declaratory judgments that the patent was invalid and Sandoz had not violated the BPCIA.
The Supreme Court decided that Sandoz did not violate the BPCIA by failing to engage in the patent dance, as consequences for failure to do so are expressly stated in the BPCIA – meaning that failure to participate was expressly contemplated by the BPCIA. The Court explained that failing to disclose its application and manufacturing information as required under 42 U.S.C. § 262(l)(2)(A) does not constitute an act of artificial infringement, but is actionable under 42 U.S.C. § 262(l)(9)(C), which permits the sponsor to bring an immediate declaratory judgment action for artificial infringement. Therefore, failure to participate in the patent dance cedes control of patent litigation to the sponsor rather than the applicant. This, rather than injunctive relief, serves as enforcement of the disclosure requirements. The Court then remanded to the Federal Circuit to determine whether an injunction is available under California state law to enforce 42 U.S.C. § 262(l)(2)(A) based on whether noncompliance with § 262(l)(2)(A) is unlawful under California’s unfair competition statute.
The Court then examined the plain language of the 180-day notice requirement and determined that no policy argument exists that could outweigh the clear textual argument: 180-day notice of marketing is permitted before licensure.

The applicant must give “notice” at least 180 days “before the date of the first commercial marketing.” “[C]ommercial marketing,” in turn, must be “of the biological product licensed under subsection (k).” §262(l)(8)(A). Because this latter phrase modifies “commercial marketing” rather than “notice,” “commercial marketing” is the point in time by which the biosimilar must be “licensed.” The statute’s use of the word “licensed” merely reflects the fact that, on the “date of the first commercial marketing,” the product must be “licensed.” See §262(a)(1)(A). Accordingly, the applicant may provide notice either before or after receiving FDA approval.

Implicitly, the Court held that reference product manufacturers are not entitled to an additional 6 months of practical exclusivity after a biosimilar is approved. Theoretically, this should help biosimilars come to market faster.
In a Concurring Opinion, Justice Breyer, citing the Court’s previous decision in National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967 (2005), raised the possibility that notwithstanding the Court’s interpretation of the BPCIA, FDA might come to a different interpretation of the statute: “if [FDA], after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation.”  It seems unlikely that FDA will depart from the Court’s decision.  

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Colgate Asks Court to Stay Action until FDA Defines “Natural”

Colgate Asks Court to Stay Action until FDA Defines “Natural”

By Riëtte van Laack – 
As readers of this blog know, natural claims have been and continue to be a frequent basic for consumer class actions. Initially, lawsuits appeared to focus on natural claims for foods (and dietary supplements). However, natural claims for personal care products also have become a popular target in consumer class actions. Even the Federal Trade Commission has addressed natural claims for personal care products (see here).
Currently, there is no single authoritative legal definition of what “natural” means in the context of food or personal care products. For foods, FDA has a policy that “natural” means “nothing artificial or synthetic,” but it remains unclear how some issues such as genetically modified ingredients and presence of certain residues, such as pesticides, fit within that policy. The continuing uncertainty has encouraged litigants to seek answers from the courts. 
In November 2015, in response to several petitions requesting clarification of the definition or prohibiting the term natural altogether, FDA announced that it would consider the use of “natural” and requested comments as to how to best define the term. The comment period closed in May 2016, after FDA received more than 7600 comments.
FDA’s action has provided defendants of consumer class actions with an additional reason that lawsuits should be stayed based on the primary jurisdiction doctrine. Pursuant to this doctrine, courts may in their discretion stay or dismiss a plaintiff’s claims, to permit the relevant administrative agency to reach a decision on the issue in question. The primary jurisdiction doctrine is intended to preserve the proper working relationship between administrative agencies and the judicial system. See U.S. v. W. Pac. R.R. Co., 352 U.S. 59, 63-64 (1956). In a number of natural cases, defendants have successfully argued for a stay and several lawsuits have been put on hold until FDA weighs in on the “natural” issue. See, e.g., Kane. v. Chobani, LLC, 645 Fed. Appx. 593, 594 (9th Cir. 2016).  
Just recently, Colgate Palmolive Co. (Colgate) relied in part on this latest FDA action in asking the Southern District of New York to also stay lawsuits concerning natural claims for its personal care products. Colgate and its subsidiary Tom’s of Maine, Inc. (Tom’s) market and sell personal care products. Last year, after FDA already had initiated its proceedings concerning natural claims, they were sued for the marketing of a number of the personal care products with allegedly false and misleading “natural claims.” Defendants argue that these cases should be stayed based on primary jurisdiction.
Defendants provide four reasons for deferral to FDA:

The determination of what constitutes “natural” is better left to the expertise of FDA;
Labeling standards are within FDA’s jurisdiction and authority;
The risk of inconsistent rulings regarding the meaning of “natural;” (Colgate got sued in New York and California);
FDA is already reviewing the meaning of natural and natural claims.

Defendants acknowledge that FDA’s action focuses on natural claims for foods, not on personal care products. However, they point out that “there is no indication that . . . FDA’s pending guidance would not also apply to personal care and cosmetic products.”
This would not be the first time that a court would stay “natural” litigation related to personal care products. In 2015, in Astiana v. Hain Celestial Group, Inc., 783 F.3d 753, 761 (9th Cir. 2015), the 9th Circuit determined that a stay was appropriate based on the primary jurisdiction doctrine. When that decision was issued, FDA had not yet initiated proceedings regarding “natural” claims. Now that FDA has in fact taken action suggesting that guidance is forthcoming, the argument for a stay is stronger; “FDA has already completed its notice and comment period, a necessary step that will inform . . . FDA’s guidance, and [FDA] seems determined to address the natural labeling issue.” This may alter the primary jurisdiction calculus, and spells a greater likelihood of success for Colgate’s motion and those of other defendants in similar litigation.

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