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The House of Representatives is processing legislation to renew the FDA’s user fee programs, a bill that includes a number of key provisions for drug and device makers alike. The bill is likely to be modified as it goes through the process before consideration by the Senate, but the provisions that deal with FDA inspections are likely to survive, such as language that would allow the FDA to request records in advance of inspections of device manufacturing facilities.
The Food and Drug Amendments of 2022 includes requirements for cybersecurity, such as a mandate that device manufacturers provide patches promptly to address emerging risks. The legislation also provides a new pilot for the Accreditation Scheme for Conformity Assessment program (ASCA), which would expire in September 2023. Thereafter, the ASCA program would become a fully realized premarket program for well understood devices. The legislation also reauthorizes the third-party program for review of 510(k) applications.
The Food and Drug Amendments encode a wide range of provisions related to inspections, such as Section 721, which expands the FDA’s ability to request records for a device manufacturing facility prior to the inspection. The agency would have to explain the reason for such a request, and a guidance would have to be issued to explain the circumstances in which a pre-inspection request for records was issued. The guidance would have to characterize the turn-around time required for providing those records, but the legislation requires that the FDA take into account the needs of small device manufacturing in meeting those deadlines.
Section 723(b) would allow the FDA to make more extensive use of facility records for the purposes of pre-approval inspections and routine surveillance inspections. This authority would be applicable to follow-up inspections as well. Another feature of the bill calls for a pilot program for unannounced inspections of drug manufacturing sites located outside the U.S.
The legislation did not include language for establishment of the Advanced Research Projects Agency for Health (ARPA-H), which was identified in a separate bill. One of the more conspicuous omissions from the user fee legislation is language enabling FDA regulation of lab-developed tests (LDTs), the exclusion of which was criticized by Rep. Larry Bucshon (R-Ind.), one of the sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021.
There is also no language in the bill related to device remanufacturing despite that this area has been controversial for some time. This regulatory question drove the FDA to release a draft guidance in June 2021, but Congress has heard from stakeholders from across the spectrum that legislative action is indicated. The subcommittee did not respond to calls from committee members to include provisions related to remanufacturing, and Rep. Frank Pallone (D-N.J.), chairman of the Energy and Commerce Committee, suggested that there was little chance that appropriate legislative language could be drafted in time for passage of the bill out of the House of Representatives.
Section 803 of the legislation deems contrast agents, radioactive drugs and OTC monograph drugs as drugs rather than as devices. The language includes a recitation of the definitions of diagnostic radiopharmaceuticals and radioactive drugs, and appears to be a response to the FDA’s loss in court to Genus Medical Technologies.
There are a number of other provisions of interest, such as those dealing with postmarket study requirements for drugs approved under accelerated approval programs. The primary element of this set of provisions is that the sponsor of a drug thus approved would have to commence with a post-approval study upon approval of the drug. The sponsor of the drug would be allowed to make use of real-world evidence in that study, and would have to report to the FDA on the progress of such studies at six-month intervals.
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