IOM REPORT BLASTS FDA, CALLS FOR MORE POSTMARKET ENFORCEMENT
The FDA should be given the authority to impose severe punishments on drug manufacturers who don't live up to their postmarketing commitments, according to an Institute of Medicine (IOM) report that offered a harsh assessment of the agency's current drug safety efforts.
The FDA is underfunded, disorganized and lacking in sufficient authority to enforce the laws on the books, according to the Sept. 22 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public." The FDA and HHS requested the study, which began 18 months ago.
IOM recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products. "These conditions may be imposed both before and after approval of a new molecular entity, new indication or new dosage, as well as after identification of new contraindications or patterns of adverse events," the report states. "The limitations imposed should match the specific safety concerns and benefits presented by the drug product."
The report suggests elements that should be part of the risk programs, including:
Distribution conditioned on compliance with agency-initiated changes in drug labels;
Distribution conditioned on specific warnings to be incorporated into all promotional materials, including broadcast direct to consumer (DTC) advertising;
Distribution conditioned on a moratorium on DTC advertising;
Distribution restricted to certain facilities, pharmacists or physicians with special training or experience;
Distribution conditioned on the performance of specified medical procedures;
Distribution conditioned on the performance of specified additional clinical trials or other studies; and
Distribution conditioned on the maintenance of an active adverse event surveillance system.
In addition, the report recommends the FDA have the regulatory teeth to ensure those requirements are met. "FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions and withdrawal of drug approval," the report states.