FDA: Hahn Era Begins

FDA’s new commissioner, Stephen Hahn, emerged in public last week by announcing his priorities at an FDA “all hands” staff meeting and further discussing challenges and issues with the press. Of prime interest were his comments on how the agency might continue to address high drug prices, whether FDA is approving new therapies too fast based on too little evidence, and new concerns arising from the fast-spreading coronavirus. 

A prominent oncologist and top official at the MD Anderson Cancer Center in Houston, Hahn won support from several former commissioners and was quickly confirmed by the Senate in December 2019, despite his limited familiarity with FDA operations or policies. Since then, he has been appointing new staffers to the commissioner’s office and reviewing prime topics on FDA’s agenda. In January, he announced the appointment of Anand Shah as deputy commissioner for medical and scientific affairs. Shah briefly was a medical officer at FDA’s Oncology Center of Excellence before moving to the Center for Medicare and Medicaid Services (CMS) where he was involved in big data initiatives. Other new senior advisors include Colin Rom and attorney Lowell Zeta. 

Hahn’s more formal presentation to FDA staffers on Jan. 30, 2020 avoided most controversial topics, such as opioids, cannabis-based medicines, vaping, and wider drug importing. A main goal of his tenure, he said, is to continue modernizing FDA information systems, an undertaking that aims to provide reviewers and analysts with better data to speed up product assessments, while ensuring that information is accurate and of high quality. He also promoted several popular initiatives, including wider use of patient input to improve information on new drugs and medical devices, and better communications with consumers. 

Another Hahn goal is to capitalize on today’s “unsurpassed scientific and technological innovation,” while also maintaining a balance between the speedy approval of new products and the integrity of the data and the process itself. He aims to support the development of newer, more effective products “while maintaining FDA’s gold standard for safety and effectiveness.” To accomplish these goals, Hahn pledged to work to ensure sufficient resources for the agency, with an emphasis on supporting efforts to retain and attract scientists and experts to the agency.  

In subsequent comments, Hahn addressed issues related to rising drug costs. While emphasizing that FDA does not traditionally deal with drug pricing, he suggested that the agency can work with Medicare and Medicaid to extend coverage and reimbursement of new therapies. And he indicated support for implementing the Trump administration’s plan to let states import drugs. 

The emergence of the coronavirus pandemic clearly will be a main concern for the new commissioner, who acknowledged that the outbreak is affecting FDA by halting staff travel to China to conduct plant inspections and deal with other issues. At the same time, FDA is poised to play an important role in efforts to develop new vaccines, treatments and diagnostic tests for the new virus.

Hahn said that FDA is closely monitoring for supply chain disruptions involving the many medical products and active ingredients imported from Asia. The growing reliance of U.S. biopharma companies on Chinese supplies and products threatens to aggravate drug shortages and increase access challenges. Members of Congress and consumer groups have been voicing concerns about the unreliable quality of drugs from China, and added FDA difficulties in overseeing the expanding global drug supply chain will further the debate.