FDA Grants 30-Day Extension for Comments to Menu Labeling Rule

FDA Grants 30-Day Extension for Comments to Menu Labeling Rule

By Etan J. Yeshua –
Last month we reported that FDA decided to delay the compliance date for restaurant menu labeling from May 5, 2017 to May 7, 2018 while it reconsiders certain aspects of the final menu labeling rule. The Agency requested comments from industry and other stakeholder about how the rule should be revised to reduce the regulatory burden on restaurants and other covered establishments: FDA said that only comments submitted within 60 days (by July 3, 2017) would be considered. Now, FDA is adding 30 days to the comment period.
The extension comes in response to a request from the National Restaurant Association (NRA). About halfway into the original comment period, NRA told FDA that it would be “nearly impossible” to prepare and submit its comments without an additional 60-day extension. Yesterday, with the deadline right around the corner, FDA stated in a letter to NRA that the Agency will extend the comment period by 30 days. Although it isn’t the full 60-day extension that NRA requested, restaurants and other interested parties will now have (by our count) until August 2, 2017 to submit comments. An official announcement of the extension (in the Federal Register) is forthcoming. FDA’s decision does not change the May 7, 2018 compliance date.

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ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II

ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II

By Kurt R. Karst –      
The second iteration of the Generic Drug User Fee Amendments (“GDUFA II), which is contained in Title III of the FDA Reauthorization Act of 2017 (“FDARA”) (S. 934 and H.R. 2430) currently pending in Congress, will, if enacted, significantly change the current user fee system and structure that have been in place the past five fiscal years under GDUFA I.  Not only will FDA collect a greater amount of user fee funding each year ($493.6 million annually adjusted for inflation), but one fee type will be eliminated (i.e., the Prior Approval Supplement fee), while others fees would be modified (e.g., a new Finished Dosage Form (“FDF”) facility fee for Contract Manufacturing Organizations (“CMO”)).  GDUFA II will also introduce a new fee type – the ANDA Holder Program Fee – that will account for 35% of annual fee funding.  The annual ANDA Holder Program Fee, along with the annual CMO FDF facility fee, are proposed as “small business considerations,” according to FDA.
Under the GDUFA II fee structure, the ANDA Holder Program Fee is set up as follows: a firm and its affiliates will pay one program fee each fiscal year commensurate with the number of approved ANDAs (both active and discontinued ANDAs) that the firm and its affiliates collectively own. The program fee to be paid each year depends on the number of ANDAs owned.  Firms will not pay a per-ANDA fee.  Instead, the program fee will be split into three tiers that represent different positions held by the firms and their affiliates within the market.  Specifically, FDARA would amend the FDC Act to add Section  § 744B(b)(2)(E) to state:

(i) Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates.  The Secretary shall determine the fees as follows:
(I) If a person (including its affiliates) owns at least one but not more than 5 approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.
(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.
(III) If a person (including its affiliates) owns 20 or more approved [ANDAs] on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.
(ii) For purposes of this subparagraph, an [ANDA] shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such [ANDA] by April 1 of the previous fiscal year.

The statute (FDC Act 744B(g)(5)) would also be amended to include certain penalties for failure to pay the new ANDA Holder Program Fee:

(A) IN GENERAL.—A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:
(i) The Secretary shall place the person on a publicly available arrears list.
(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A).
(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa).
(B) APPLICATION OF PENALTIES.—The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.

We don’t yet know exactly how much the annual ANDA Holder Program Fee will be for Fiscal Year 2018, but at 35% of the overall GDUFA user fee funding, we assume it could be a decent amount of cash for some companies to lay out. And for some companies with a small number of ANDAs, they’ll be laying out cash for drug products that they don’t currently market, because their ANDAs are in stasis, as identified in the Discontinued Drug Product List section of the Orange Book. 
FDA is currently collecting information from ANDA sponsors – see here and here – in an effort to set the fee.  In the meantime, our friends over at the Lachman Consultants Blog recently provided a “back of the envelope”  calculation based on the total fees FDA will collect under the ANDA Holder Program Fee initiative.  They estimate that companies in the small tier will pay $130,780; companies in the medium tier will pay $523,120; and that companies in the large tier will pay $1,307,800.
A new venture might offer some user fee relief and a solution to companies that have discontinued ANDAs for drug products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com) is offering what we can only characterize as “ANDA arbitrage.”  Imagine, if you will, a parking lot.  The owner of a car that is not being used on a daily basis needs a parking space for that car.  In exchange for that parking space (and an annual fee) the car’s owner transfers title of the automobile to the parking lot owner.  The old owner of the car can, with appropriate notice, take back ownership when he decides that he wants to use the automobile again.  Provided the parking lot owner has enough cars, this can be a beneficial venture for all of the parties involved. 
In the imagery above, the automobile owner is an ANDA sponsor, and the parking lot owner is ANDA Repository, LLC. If ANDA Repository, LLC is able to obtain title to 20 or more ANDAs, then the company will be identified as a “large size operation” and will pay a full generic drug applicant program fee regardless of how may additional ANDAs are owned. In exchange for its services, ANDA Repository, LLC will charge an ANDA sponsor an annual fee, which would be significantly less than the ANDA Holder Program Fee such ANDA sponsor would otherwise pay as a small or medium size operation.   Not a bad idea!

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A Few More Steps in FDA’s Drug Competition Action Plan

A Few More Steps in FDA’s Drug Competition Action Plan

By Sara W. Koblitz –
As a prelude to FDA’s Hatch-Waxman Act public meeting next month, FDA announced today an updated a Manual of Policy and Procedures (MAPP) for review of generic drug applications and a public list of off-patent and off-exclusivity NDA products without ANDA competition. 
Effective June 27, 2017, MAPP 5240.3 Rev. 3, Review Order of Original ANDAs, Amendments, and Supplements, updates FDA’s system of priority for review of generic drug applications at all stages of review.  While FDA’s ranking system of types of submissions that will have review priority for OGD has not changed, the MAPP adds as a top review priority generic products for which there are no blocking patents (carved-out patents are not considered blocking) or exclusivities and fewer than three approved ANDAs for the RLDs.  This is a change from the previous MAPP, which only prioritized the review of “first generic products” for which there are no blocking patents or exclusivities for the RLD.  According to FDA’s press release, the policy revision is “based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.”
To encourage more competition, FDA also published today a List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.  This list basically serves as a “hit list” for generic manufacturers.  FDA announced in its press release that, in accordance with the revised MAPP, it intends to expedite review of any generic drug application on this list.  Part I of the list identifies products for which FDA could immediately accept an ANDA without prior discussion with FDA, while Part II identifies drug products that may raise legal, regulatory, or scientific issues that should be addressed with FDA prior to ANDA submission (these could be drugs for which a 505(b)(2) is more appropriate or drugs with complex bioequivalence profiles).  Products are identified based on the Orange Book-listed active ingredient, and the list does not differentiate between strength or dosage forms of the same active ingredient.
The list was compiled based on Orange Book Data files accessed May 30, 2017 and will be updated approximately every six months.  NDAs approved in the last year were omitted. 
Both of these efforts combined are part of Commissioner Gottlieb’s Drug Competition Action Plan, designed to address competition and pricing in the generic drug market.  It’s clear that this endeavor is a priority for Commissioner Gottlieb, so we expect more on this initiative soon.

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GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees

GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees

By Kurt R. Karst –
In a new report issued earlier this week, titled “Generic Drug User Fees: Application Review Times Declined, but FDA Should Develop a Plan for Administering Its Unobligated User Fees,” the U.S. Government Accountability Office (“GAO”) examines several aspects of FDA’s implementation of the first iteration of the Generic Drug User Fee Amendments (“GDUFA”). Responding to an inquiry from the U.S. Senate Committee on Health, Education, Labor, and Pensions, the GAO: (1) examines how user fees supported FDA’s generic drug program; (2) describes FDA’s improvements to the generic drug application review process; and (3) analyzes changes in generic drug application review times.  In an appendix to the report, GAO also includes a discussion of the various regulatory science initiatives funded under GDUFA and identified in the GDUFA I Commitment Letter.
Overall, the GAO found that GDUFA user fee funding has been used well to improve FDA’s generic drug program. “FDA has used its user fee funding to enhance OGD’s ability to increase hiring, and undertake numerous activities to improve and speed-up the review of generic drug applications,” says the GAO.  These improvements are apparent in decreased first cycle ANDA and Prior Approval Supplement (“PAS”) review times:

With respect to ANDA review times, the average time for FDA to complete the first review cycle decreased from 26 months for ANDAs submitted in fiscal year 2013 to about 14 months for those submitted in fiscal year 2015. . . . However, as of December 31, 2016, 929 ANDAs (34 percent) submitted since the start of the generic drug user fee program in fiscal year 2013 were still pending review.  As these applications are reviewed, the average review time . . . for each fiscal year will increase since all of the applications that remained to be acted on are at least 15 months old.  As of December 31, 2016, FDA had also acted on 89 percent of all ANDAs submitted in fiscal year 2015 within 15 months of receipt, exceeding its GDUFA goal of acting on 60 percent of ANDAs received in fiscal year 2015 within 15 months. . . .
For PASs, the average time for FDA to complete the first review cycle also declined from 12 months in fiscal year 2013 to 4.5 months in fiscal year 2015.

Despite the decrease in original ANDA and PAS first cycle review times, where the rubber meets the road is in approvals. As Office of Generic Drugs Director Kathleen “Cook” Uhl noted earlier this year only 9% of ANDAs in the Fiscal Year 2015 application cohort were approved (or tentatively approved) during a first cycle review, while 71% were the subject of a Complete Response Letter.  The anemic approval figure improved to 42% (and 56% for Complete Response Letters) on a second cycle review. 
The GAO’s biggest criticism of FDA’s implementation of GDUFA concerns the Agency’s lack of a plan for dealing with user fee carryover. “FDA has accumulated a large unobligated user fee carryover balance, which it uses as an operating reserve,” says the GAO. “At the beginning of fiscal year 2017, FDA had a carryover of approximately $174 million.”  That figure is way down from the staggering $278 million carryover FDA had amassed by the end of Fiscal Year 2014.  Nevertheless, it’s “an amount nearly as great as the annual, inflation-adjusted user fee collection amount of $299 million” established under GDUFA I, notes the GAO. 

Despite the large carryover amounts, FDA has not developed a planning document on how it will administer its carryover—one that includes a fully documented analysis of program costs and risks to ensure that its carryover reflects expected operational needs and probable contingencies. Although FDA uses an internal management report to show GDUFA collection amounts, obligations, and end-of-year carryover amounts, the agency was unable to produce evidence describing whether the carryover of $174 million at the beginning of fiscal year 2017 (or carryover amounts in other years) was within a targeted goal, and it does not have targets for future years in general.

To deal with this lingering issue, and to “ensure efficient use of generic drug user fees, facilitate oversight and transparency, and plan for risks,” the GAO recommends that FDA Commissioner Gottlieb “develop a plan for administering user fee carryover that includes analyses of program costs and risks and reflects actual operational needs and contingencies.”

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Field Alert Reports – FDA Introduces the Automated Form 3331a

Field Alert Reports – FDA Introduces the Automated Form 3331a

By Mark I. Schwartz –
Earlier this year, we blogged about FDA’s Field Alert Report (or FARs) reporting requirements under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since 1985, when the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i).
At the time of our blog on the issue, among other things, we referenced FDA’s Compliance Program Guidance Manual 7356.021, which provides instructions to FDA personnel for conducting activities to evaluate industry compliance with FDA’s field alert reporting requirements. We also referenced Form 3331, which is the form manufacturers are expected to use to submit their FARS.
What we did not mention is that in May of 2013, FDA had launched a voluntary pilot program to modernize the FAR submission and review process by allowing firms to submit FARs electronically using an XML-enabled PDF form. XML stands for “Extensible Markup Language”, and it is a meta-language which allows users to define their own customized markup languages, particularly to display documents on the Internet. The XML-enabled form is known as FDA Form 3331a, and it eliminates the need to fax or scan the form to the firm’s local FDA field office.
This pilot project ended on June 15th, 2017, and the agency has stated that the following objectives for the pilot project were achieved:

Allowing simultaneous reporting to FDA’s Office of Regulatory Affairs (ORA) and CDER; and

Determining the feasibility of transitioning from a simple PDF to a functional PDF.

FDA concluded that the use of the automated form “…improved the speed and efficiency of reporting on product quality issues related to the manufacture of drug products approved under a new drug application (NDA) or abbreviated new drug application (ANDA) by FDA.”
With the data that FDA gathered from FARs submissions over the four year period of the pilot project, as well as from explicit feedback from pilot project participants, the agency has created a new version of the automated Form 3331a. Some of the changes to the form that was used in the pilot project are as follows:

Fields have been rearranged;

Most of the fields are now expandable;

The lot number and expiration date fields have been combined;

The dosage form and strength/package size data are now in separate fields;

The problem and reporting firm sections now have separate fields for individual address components;

The reporting firm is now asked to provide a DUNS (Data Universal Numbering System) or FEI (Facility Establishment Identifier) number;

The new version of the form can be used to submit FARs for NDA or ANDA products that fall under the jurisdiction of CDER or CBER;

Signatures are not required.

FDA also mentioned that the agency is working on meeting the technical requirements for receiving FARs as part of the electronic Common Technical Document (eCTD) through the Electronic Submissions Gateway, and that this process will be described in a future guidance document.

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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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