FDA Regulatory

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.

As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for later action. Here’s what we’re tracking for a 2020 health care legislative package.

Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the Act: (i) emphasized the agency's responsibility to identify class II devices that may be exempted from premarket notification (or 510(k)) requirements, and (ii) required the agency to publish a list of each type of class II device that the Food and Drug Administration (FDA) determines no longer requires a 510(k) submission to provide reasonable assurance of safety and effectiveness at least every five years, or as appropriate. On December 30, 2019, FDA published a final notice of its amendments to each classification regulation for the newly exempted devices.

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges unresolved. Most notable changes to law are the elimination of three Affordable Care Act taxes and the passage of the CREATES Act. Noticeably absent is legislation related to surprise billing and prescription drug pricing. A summary of key health care provisions included in the 2020 Consolidated Appropriations Act (P.L. 116-94) follows. We will address the legislative outlook for 2020 in a separate ML Strategies blog post next week.

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” (You can find our two prior posts on medical devices and prescription therapeutic products here and here, respectively.) In taking a wide-lens view of the past year, we see it as having presented a huge number of opportunities for the FDA to educate the public about its role in regulating non-prescription products sold directly to consumers. Most of the educational opportunities we highlight below came in concert with some other agency actions, like the issuance of Warning Letters to specific firms, but we’ve decided to cover only the key issues in the interest of keeping this post from turning into a long list of hyperlinks given the post’s already broad scope. Consumer products that fall within FDA’s jurisdiction include over-the-counter (OTC) drugs and OTC homeopathic drug products; tobacco and other nicotine delivery products; dietary supplements; foods and beverages for both humans and animals (technically, there is no such thing as an animal “dietary supplement”); cosmetics (sort of); and a wide variety of cannabis-derived consumer products that exploded onto the national landscape during 2019 and essentially cross into all of the aforementioned product categories.

The Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration’s nominee to head the Food and Drug Administration (FDA), on December 3, 2019. Hahn faced a flurry of questions at the confirmation hearing before the Senate Health Committee on Wednesday, November 20, 2019, most of which spoke to the youth vaping crisis with little emphasis on other hot topics such as prescription drug shortages or drug pricing. Despite the barrage of questions, many of his responses were non-specific in nature and avoided committing to any set platform. Instead, Hahn focused on his pledge as a doctor to put patient care first and rely on science and data as a basis for decision-making.

Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts, and ongoing media coverage, drug shortages remain a significant public health crisis in the United States. In response to that crisis (and at Congress’s urging), the FDA formed the interagency Drug Shortages Task Force (Task Force) to study the issue. FDA has now released the report resulting from the Task Force’s activities: “Drug Shortages: Root Causes and Potential Solutions.” The report, issued on October 29, 2019, concludes that drug shortages are primarily the consequence of economic factors driven by private and public business practices. Those practices, according to the report, disrupt the supply chain availability of marketed pharmaceuticals. The report offers recommendations to provide a framework for stakeholders to address the underlying economic factors leading to drug shortages.

On September 26, 2019, FDA released a six revised digital health guidances. The primary objective of these revisions was to bring the guidances into alignment with the software function exemptions described in Section 3060 of the 21st Century Cures Act (the “Cures Act”). The medical device community has anticipated these changes since Congress passed the Cures Act almost three years ago in December 2016.

As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the authority to compel drug manufacturers from disclosing drug prices in direct-to-consumers television advertisements (DTC rule). On September 23, 2019, HHS filed its appeal in the D.C. Circuit against plaintiffs Merck & Co., Eli Lilly and Co., and Amgen Inc. The brief argues that the district court erred in holding that HHS lacks the statutory authority through the Social Security Act (SSA) to force the DTC rule upon drug manufacturers because they are not direct participants in the Medicare and Medicaid programs.