FDA Seeks Mandatory Drug Recall, Other Powers
Responding to a question posed during a 5/23 hearing held by the House Energy and Commerce Committee Health Subcommittee, CDER director Patrizia Cavazzoni said FDA would benefit from having the authority to order mandatory recall of harmful drugs. “We have that authority for lettuce, but not for drugs,” she said.
The hearing’s theme was “Check Up: Examining FDA regulation of drugs, biologics, and devices.”
Cavazzoni referenced a recent case of contaminated eye drops in which users were being harmed while the manufacturer resisted recalling the drugs. She also cited a case of a contaminated hand sanitizer that was being sold during the Covid pandemic.
Asked if FDA would benefit by getting information from drug companies on when there is an increase in demand for a drug that could lead to a shortage, Cavazzoni said that authority also would be very helpful and could enable the agency to intervene and potentially prevent a shortage rather than have to work to mitigate one.
Cavazzoni appeared before the committee with CBER director Peter Marks and CDRH director Jeffrey Shuren.
Asked about accelerated approvals, Marks and Cavazzoni both reiterated that any product given an accelerated approval has met the agency’s standards and is likely to be effective in at least some patients.
In their prepared testimony, the three reviewed agency progress on several fronts and made a pitch for additional congressional support. “For all the progress we have made,” they said, “there are areas where we need Congress’ support to ensure we can continue to effectively balance innovation, access, and safety. There are existing gaps regarding the agency’s ability to effectively monitor drug and medical device supply chains, for instance. Similarly, the existing regulatory pathways do not provide adequate flexibility for medical device manufacturers to adopt best practices for development, deployment, or continuous maintenance of artificial intelligence/machine learning-enabled medical devices….. We are seeking updates to the statutory framework governing drugs and biologic products, including to modernize the framework for generic drugs … to facilitate the development of complex generic drugs, including drug-device combination products.”