User Fee Bill Looks to Improve Accelerated Approval, Inspections
The House Energy and Commerce Committee has released a “comprehensive legislative package” to reauthorize FDA user fee agreements and enhance other agency program areas. The legislation, “Food and Drug Amendments of 2022,” will be introduced this week, followed by a Health Subcommittee mark up next week.
According to a summary of the proposed legislation, Section 804 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.” It also 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. It also streamlines procedures for FDA to follow to withdrawal approval when conditions are not met.
Regarding modification of FDA’s inspection authorities, Section 721 expands 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. Sec. 723 is intended to enhance FDA’s inspection tools and requires a study of when and how those tools are used. It also 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.
Additionally, the proposal codifies and clarifies FDA’s authority to inspect clinical study sites, and it would require FDA to review its processes and practices regarding these inspections and issue guidance describing how they are conducted.
Section 724 would require a Government Accountability Office report on FDA inspections of foreign establishments manufacturing drugs, and Section 725 would require the agency to conduct a pilot program on unannounced surveillance inspections of foreign drug establishments, and evaluate the differences between domestic and foreign establishments, including the impact of announcing such inspections.
And Sec. 729 aims to enhance the transparency of drug facility inspection timelines by requiring FDA to publicly post, not later than 120 days after the end of each fiscal year, information related to inspections of facilities, including inspections that are necessary for approval of a drug or device. “Such information shall include the median time following a request from FDA staff reviewing an application to the beginning of an inspection, as well as the median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the actions indicated to address the conditions or practices observed during an inspection,” the summary says.