The new Commissioner of the US Food and Drug Administration (FDA), Dr. Scott Gottlieb, testified before the Subcommittee of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the Appropriations Committee of the US House of Representatives in a hearing discussing the fiscal year (FY) 2018 budget of the agency.
In his opening comments, Dr. Gottlieb addressed one of his key priorities for the agency: to increase competition to help mitigate high drug costs. "Simply put, too many patients are priced out of the medicines they need," he said in his testimony delivered on May 25, 2017. "While FDA does not play a direct tole in drug pricing, we can take steps to facilitate the entry of low-cost alternatives to the market and increase competition."
He said that is particularly true for generic drugs, and that the FDA plans to issue a drug competition action plan in the near term to address this issue.
He highlighted several areas to improve the review process for generic drugs, including improved communication between the FDA and generic drug companies individually and collectively through more helpful guidance documents.
In his testimony, Dr. Gottlieb highlighted three priorities with respect to the generic-drug review process and ways to increase product competition. First, was to "curtail gaming by the industry" that extend what the he termed as "monopolies" beyond the times that Congress had intended. Second was to improve the approval process for complex generic drugs. Third was to improve the efficiency of the generic-drug review process, including eliminating the backlog of generic-drug applications, which he said would require action by both the FDA and industry
In further elaborating on ways that the FDA can participate in improving competition, Dr. Gottlieb outlined three other actions that the FDA plans to take. First is a plan to hold a public meeting to evaluate what he termed as "manipulation" of the Risk Evaluation and Mitigation Strategy (REMS) process to slow entry of generic drugs. The second is to provide additional guidance to reduce multiple cycles of review of generic drugs. Lastly, would be a move by the FDA to improve transparency by highlighting off-patent drugs that lack competition and to update such a listing on a regular basis to encourage more generic-drug entries to improve competition.
In answering a question on the priorities of the FDA, he higlighted three: (1) address drug pricing by improving competition as previously outlined; (2) address the opioid crisis; (3) and stimulate new drug innovation through various means, such as through the implementation o the 21st Century Cures Act.
Source: Subcommittee of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the Appropriations Committee of the US House of Representatives