House Subcommittee Unanimously Votes Out User Fee Bill
In a rare exhibition of bipartisanship, the House Energy and Commerce Committee 5/11 unanimously voted (30 to 0) to advance a legislative package that would reauthorize FDA user fees for an additional five years and enhance several FDA programs. The package now heads to the full committee for consideration and a final vote before likely moving to a vote on the House floor.
In addition to user fees reauthorization, the “Food and Drug Amendments of 2022” (see earlier story) covers enhancements to postapproval studies for accelerated approval drugs. It requires FDA to “specify conditions for required postapproval studies for drugs approved under accelerated approval, which may include enrollment targets and milestones, including the target date for study completion, by the time the drug is approved,” according to a summary of the package. It authorizes FDA to require postapproval studies, which may be supported by real world evidence, to be underway at the time of approval for these drugs and requires an agency explanation for any instances where it does not require such studies. The bill also streamlines procedures for FDA to follow in withdrawing approval when conditions are not met.
FDA’s inspection authorities would also get a boost under the legislation by expanding the agency’s ability to review medical device manufacturer records in advance or in lieu of an inspection. Its current authority allows for requesting records from drug manufacturers only. It would also strengthen FDA’s inspection tools and requires a study of when and how those tools are used. And it authorizes FDA to “use any records or other information collected for the purposes of or in lieu of an inspection to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, and to resolve deficiencies found in such inspections, if applicable and appropriate,” according to the summary. It also would codify the recognition of foreign government inspections as being sufficient for preapproval inspections if the agency has an agreement with the specific foreign government.
The House package also aims to address an agency predicament caused by a 2021 appeals court decision that has disrupted FDA’s orphan drug program (see earlier story). According to the summary, the legislation would amend Section 527 of the Food, Drug, and Cosmetic Act regarding orphan drugs “to provide clarity that exclusivity applies only to the specific indication or use approved by FDA under this section, not the entire rare disease or condition for which the drug was designated, consistent with FDA’s long-held interpretation of the law.”
Additionally, the legislation would correct another court decision that disrupted how FDA regulates contrast agents. The dilemma stems from a 4/2021 decision from the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, which affirmed a district court ruling that FDA does not have discretion when a combination product meets the definition of being both a device and a drug (see earlier story). The bill would deem all contrast agents, radioactive drugs, and over-the-counter monograph drugs regulated as drugs, not medical devices.