Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegLast week, the U.S. Food and Drug Administration published the Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.  Commonly referred to as the “goals letter” or “commitment letter,” the publication represents discussions among FDA, the regulated industry, and public stakeholders regarding reauthorization of the Biosimilar User Fee Act (“BsUFA”).



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Written by Scot B. Pittman

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BsUFA authorizes FDA to collect user fees for the review of biosimilar biological product applications.  The current legislative authority for biosimilar user fees expires in September 2017, and FDA cannot continue to collect user fees without reauthorization.  Relatedly, on Monday, FDA announced that it will hold an upcoming public meeting to discuss proposals for reauthorization.  The proposals include enhancements to the existing biosimilars user fee program in four key areas: (i) review performance; (ii) meeting management; (iii) guidance development, and (iv) fee/program administration.

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On September 9, 2016, Apotex Inc. filed a petition for a writ of certiorari in the Amgen Inc. v. Apotex Inc.[1] case decided by the Federal Circuit on July 5, 2016.  Apotex’s petition was placed on the Supreme Court’s docket on September 14, 2016 as No. 16-332.  Amgen’s response is due on October 14, 2016.

There are two issues raised in Apotex’s petition: (1) whether a biosimilar applicant must provide notice of commercial marketing when it complied with the patent dance; and (2) if notice of commercial marketing is required, whether notice can be effective prior to FDA approval of the biosimilar application.  The Federal Circuit held that notice of commercial marketing is mandatory and not effective until after the biosimilar application is approved.  Amgen, 2016 U.S. App. LEXIS 12353, at *36 (“We conclude that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”).

Apotex makes two arguments in its petition: (1) the notice of commercial marketing provision provided by the Biologics Price Competition and Innovation Act (“BPCIA”) is not mandatory, especially where the biosimilar applicant engaged in the patent dance; and (2) even if notice is required, it can be provided before a biosimilar application is approved.

On July 29, 2016, President Barack Obama signed S.764 into law. The law amends the Agricultural Marketing Act of 1946 to require that the U.S. Department of Agriculture (“USDA”) establish and oversee a national bioengineered food disclosure standard. Under the law, USDA has two years to promulgate regulations that establish the disclosure standard, as well as any related requirements and procedures that the Agency deems necessary.

Under the law, any disclosure regulations that USDA promulgates shall: (i) prohibit a food from being considered “bioengineered” solely because the animal from which it was derived consumed feed that was bioengineered; (ii) set the amounts of a bioengineered substance that need to be in a food for it to be considered “bioengineered”; (iii) establish a process by which other considerations may be given to whether a food is “bioengineered”; (iv) require that the bioengineered disclosure be a text, symbol, or electronic or digital link (e.g. a QR or Quick Response Code), with the disclosure option to be selected by the food manufacturer; (v) provide alternative reasonable disclosure options for food with small packaging; (vi) for “small food manufacturers,” provide at least one additional year for compliance with the disclosure regulations, as well as the additional option to disclose that the food contains bioengineered material through a phone number or internet website, (provided that they indicate that the number or URL provides access to additional information); and (vii) exclude food served in restaurants or “very small food manufacturers”—to be defined by USDA—from the disclosure requirements.

While the law should ultimately lead to more information on food labeling and enable consumers to make more informed choices about their food, it has also received significant criticism. For example, opponents of the law say that the definition of “bioengineered foods” is unduly narrow.

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Congress passed the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) to give the U.S. Food and Drug Administration (“FDA”) new authority to regulate the safety of marketed drugs. As part of this authority, FDA may require drug companies to propose and implement Risk Evaluation and Mitigation Strategy (“REMS”) for certain drugs whose risk- benefit profiles warrant safety measures beyond professional labeling. FDA may require REMS as part of the approval of a new drug or biologic (brand or generic), or for an approved product when new safety information arises. If FDA determines that a drug has been shown to be effective but is associated with an adverse drug experience, the FDA will require that the REMS have elements to assure safe use (“ETASU”). An example of an ETASU is that health care providers who prescribe the drug have particular training or experience or are specially certified.

The FDA, Federal Trade Commission, and generic drug manufacturers have raised concerns that branded drug manufacturers could be using REMS to impede generic competition. One concern is that branded companies may use REMS distribution restrictions to deny generic companies the drug samples they need to conduct necessary testing and otherwise meet the requirements for generic drug approval. Another concern is that branded drug firm may abuse situations where FDA approval of a generic drug is conditioned on the utilization of a single, shared ETASU by both the generic and branded companies. Essentially, the concern is that branded firms are impeding negotiations of a single, shared ETASU in order to delay generic entry.

To address these concerns, the Senate Judiciary Committee introduced Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016 on June 14, 2016. The bill—co- sponsored by Senators Grassley (R-IA), Klobuchar (D-MN), Leahy (D-VT), and Lee (R-UT)— permits a generic manufacturer to sue the branded manufacturer if: (1) the branded manufacturer fails to “provide sufficient quantities of [a drug sample] on commercially reasonable, market- based terms”; or (2) branded and generic manufacturers are unable to develop single, shared ETASU after 120 days of initiating a request to develop a shared ETASU. The relief contemplated in the bill is (1) a court order that the brand company provide the drug sample or the brand and generic develop single, shared ETASU or generic firm join a pre-existing ETASU; and (2) monetary award.

FDA has recently challenged the use of wooden planks (shelving) to age certain cheeses, a practice that has been going on for centuries. The Agency is concerned that wood absorbs and retains certain bacteria, such as listeria, that can sicken cheese consumers. Many domestic and imported cheeses are aged on wood shelves, such as parmesan and certain blue varieties.

Thumbnail image for Thumbnail image for 120px-Components_of_a_MiniCiggy_e-cigarette.jpgThe Food and Drug Administration introduced a proposed rule yesterday that would extend its existing authority over certain tobacco products. Under the proposed rule, FDA would now oversee electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables. These products would be added to the ones already under FDA’s authority–cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave FDA the authority to regulate the manufacture, distribution, and marketing of “tobacco products” to protect public health. The statute defines “tobacco products” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” The Act specifically delineated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco as products over which FDA had authority. But Congress also provided that FDA had authority over “any other tobacco product that the Secretary by regulation deems to be subject to this chapter.” Accordingly, through this proposed rule, FDA is “deeming” electronic/e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe/hookah tobacco, and dissolvables to be “tobacco products” subject to FDA regulation. Under the rule, any future products that meet the statutory definition of “tobacco product” would also be deemed to be subject to FDA’s authority.
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for gavelgold.jpgZogenix, Inc., the San Diego-based manufacturer of the extended-release hydrocodone drug Zohydro ER, has sued the Governor of Massachusetts in U.S. District Court in Boston to overturn as unconstitutional the state’s recent prohibition against prescribing and dispensing the medication.

Zohydro ER is the only FDA-approved hydrocodone drug indicated for daily, round-the-clock, long-term treatment of chronic pain for which other pain treatments are inadequate. The product, which was approved last year, is also the only available extended-release opioid drug containing hydrocodone alone, not combined with acetaminophen, which has been associated with liver damage.

The Governor of Massachusetts recently issued an “emergency declaration” establishing the ban, without consulting Zogenix, on the ground that a hydrocodone-only drug presents a greater risk of overdose and abuse than a hydrocodone combination drug. The ban would remain in place until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.”
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functional foods.jpgFoodborne illness affects approximately forty-eight million Americans per year, according to recent data from the CDC. Consumers have heard news stories warning of nationwide food recalls. What additional steps can be taken to ensure food safety? The FDA Food Safety Modernization Act was designed to address that question. Included in Section 211 of that Act are new provisions related to a Reportable Food Registry system (RFR) for increasing the speed of investigation and action to address foodborne illness (this is separate from FDA’s recall program). Although FDA already had a public meeting in June 2011, the agency only received three comments, and believes it needs further input. So, on March 26, 2014, FDA published an advance notice of proposed rulemaking (ANPR) seeking public comment through June 9, 2014.

The proposal may require submission to FDA by a responsible party through the RFR of consumer-oriented information regarding a reportable food (information necessary to accurately identify whether a consumer possesses a reportable food) within twenty-four hours of discovery of an event. A “responsible party” is the person that submits a food facility registration related to the reportable food. A public health official may also submit a report, but not consumers. FDA would assess the information and publish a standardized one-page summary on its website for purposes of notifying consumers. FDA may require the responsible party to notify or provide contact information for upstream and downstream supply chain entities. Grocery stores that sold the reportable food would be required to prominently display that information within twenty-four hours of the FDA’s website posting, and for a period of 14 days. FDA is required to develop a list of acceptable conspicuous locations and manners for grocery stores to post the information.

“Consumer-oriented information” would include a description of the reportable food, production identification codes for the reportable food, contact information, and any other information for the consumer to identify the reportable food. “Reportable foods” are those “for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals.” The new provisions will also not apply to fruits and vegetables.
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for FDA.bmpFDA issued a draft guidance on March 18, 2014 titled, “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations.” This draft guidance seeks to revise and update FDA’s March 2003 guidance titled, “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations.” This document provided guidance for NDAs, INDs, and ANDAs. In December 2013, FDA issued a draft guidance that deal with these issues solely for ANDAs. This week’s draft guidance tackles the remaining portion of the subject matter in the 2003 guidance: NDAs and INDs. Like the draft guidance on ANDAs issued in last December, this March 2014 draft guidance should not surprise those familiar with FDA’s bioequivalence (“BE”) requirements; however, it helpfully clarifies and updates a number of long-standing Agency positions.

The instant draft guidance describes that BE documentation could be useful in the IND and NDA context to compare various formulations implicated at various stages of the application life-cycle. For example, BE studies may be useful in the pre-approval context to compare: (1) formulations used in various stages of clinical trials, (2) clinical trial formulations with formulations used in stability studies; (3) clinical trial formulations with proposed final formulations; and (4) product strength equivalence. In the post-approval context, BE studies are required by FDA under certain circumstances if the innovator makes changes to the formulation.

FDA’s draft guidance issued this week also covers methods to document bioavailability and bioequivalence. It is not unexpected that the draft guidance devotes a significant portion to pharmacokinetic studies, laying out considerations relevant to study size, population, moieties to be measured, and pharmacokinetic measures of system exposure, to name a few. The usage of partial measures of exposure has been heavily debated in the past and this draft guidance confirms that they can be used in certain situations. The draft guidance also states, “[t]he time to truncate the partial area should be related to a clinically relevant PD measure.” The draft guidance also covers in vitro tests with in vivo correlation, pharmacodynamic studies, comparative clinical studies, and in vitro studies. Further, the draft guidance provides considerations specific to dosage forms, such as solutions (and other solubilized dosage forms), immediate-release products, and modified-release products.
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foodlabel.JPGLast week, the Food and Drug Administration proposed an amendment to its labeling regulations for conventional foods and dietary supplements to update the nutrition information (e.g. the Nutrition Facts labels) on packaged foods/drinks. The updates would come from two proposed rules that are published in the Federal Register. The first–Food Labeling: Revision of the Nutrition and Supplement Facts Labels–addresses new scientific information and design changes; the second–Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments–addresses serving sizes, labeling requirements based on package size, and other issues.

FDA has grouped the proposed changes into three categories: (1) Greater Understanding of Nutrition Science; (2) Updated Serving Sizes and Labeling Requirements; and (3) Refreshed Design. Below is a summary of the significant proposals for each category.

1. Greater Understanding of Nutrition Science

  • New labels must include information about “Added Sugars”
  • Updated “Daily Values” for certain nutrients, including sodium, dietary fiber and Vitamin D
  • Require listing of potassium, Vitamin D, calcium, and iron amounts
  • Permit listing of Vitamins A and C amounts
  • Remove “Calories from Fat”

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