FDA After Gottlieb: Thorny Issues, Political Challenges

08 May 2019

Jill Wechsler / Pharmaceutical Executive

During the nearly two years that Scott Gottlieb headed FDA, the agency achieved record approval rates for new drugs and generics and advanced important innovations in clinical research and benefit/risk assessment to enhance R&D and competition in the biopharmaceutical industry. The agency issued multiple new rules and guidance documents and utilized important new authorities to expand staff expertise and agency capabilities. And Gottlieb successfully navigated the political pitfalls of Washington to gain increased funding for the agency and support for more aggressive action to promote public health.

Two critical public health issues drew visible FDA attention. The agency championed steps to curb excessive opioid prescribing while also encouraging the development of safer and more effective painkillers. This includes recent support for a comparative standard to limit approval of new opioid therapies to only those offering clear additional benefits.

At the same time, data showing sharp increases in teen use of nicotine products prompted a high-profile campaign to curb “vaping” and flavored cigarette use by the young, while maintaining access for adults looking to stop smoking. Proposed curbs on tobacco use, however, has drawn strong opposition from industry and threatens to block tighter FDA limits on e-cigarette sales.

In fact, it will be a challenge for any newcomer, even an experienced scientist and administrator as former National Cancer Institute director Ned Sharpless, to maintain the broad support needed to devise and implement the vast range of important FDA initiatives, as seen in the diverse portfolio of activities described in the agency’s 2020 budget request to Congress. FDA is involved in advancing medical countermeasures, ensuring a safe national blood supply, overseeing drug compounding, and preventing and detecting contamination of the nation’s food supply, in addition to promoting medical product safety and innovation. 

Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs, further described the range of programs demanding continued agency expertise and resources at an April meeting sponsored by the Alliance for a Stronger FDA. (Similarly, Sharpless outlined his priorities and goals in an introductory speech to FDA staff, see facing page). In addition to reducing opioid addiction and tobacco use, FDA is responsible for ensuring cosmetic safety and improving nutrition, including limiting exposure to untested and potentially dangerous dietary supplements. A personal interest of Abram is to devise appropriate policies for overseeing cutting-edge innovations in plant and animal biotechnology, raising delicate issues such as genome editing in animals and tissue-based veterinary products. Abram also is involved in FDA efforts to protect Americans from global disease threats and biochemical attacks, which require close collaboration with the Department of Defense and other US and international partners to build and sustain needed medical countermeasures. 

Competition and costs

As the Trump administration and Congressional leaders press for action to reduce drug prices, a difficult task for the FDA commissioner is to explain how expanded drug importing could open the door to unsafe products from abroad, as illustrated by the surge in lethal forms of fentanyl and contaminated active ingredients for blood pressure medicines coming from overseas. Gottlieb was particularly adept at articulating how FDA can help lower prescription drug costs through more efficient approval of generic therapies and biosimilars that enhance competition. This involved repeated criticism of innovator actions designed to block access to supplies needed to test new generics for equivalence.

FDA leaders are continuing such initiatives, as seen in efforts to approve more generic drugs more quickly, particularly those in categories that lack competition. While generics makers applaud those efforts, they’re unhappy about a recent FDA proposal to curb extensions to the 180-day exclusivity offered the first-approved generic in a class. Abram noted in her Alliance speech that in March 2020, FDA will be able to inject competition into the insulin market through added authority to approve biosimilar and interchangeable insulin products, which should enhance patient access to more affordable diabetes treatment. 

During his tenure at FDA, Gottlieb sought to increase direct contact between the commissioner and center directors so that agency leadership could better understand staff challenges and priorities. That reform was formally implemented as part of an agency reorganization plan finalized just before Gottlieb’s departure. In addition, FDA centers adopted a range of internal organizational changes during the past two years, particularly for the approval and oversight of medical devices and for cell and gene therapies regulated by the Center for Biologics Evaluation and Research (CBER). The Center for Drug Evaluation and Research (CDER) continues to revise its Office of New Drugs, establishing additional new drug review offices along with a new Office of Therapeutic Biologics and Biosimilars. 

Still to come are broader changes and adjusments in oversight of over-the-counter medicines and updates in FDA regulation of diagnostics. 

Gottlieb gained expanded FDA resources and authority by building strong relations with legislators, stakeholders, and industry. He generated enthusiasm for many agency proposals through a barrage of official announcements and Twitter and social media commentary. Many observers expected him to come to FDA as a deregulator, canceling rules and requirements, he acknowledged as he left the agency last month. Instead he pointed to evidence that he expanded FDA authority, particularly in critical public health areas. He left FDA in good hands, but facing further upheavals in federal healthcare policy and partisan infighting likely to stymie regulatory innovation and squeeze future agency resources. 

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