In a nutshell, the report finds the agency to be: under-funded and increasingly dependent on PDUFA fees from the industry it regulates; handcuffed in terms of how it uses those PDUFA funds, resulting in an essentially exclusive focus on pre-approval activity; and basically toothless in terms of its authority to regulate once a drug has received approval.
The entire report is worth reading, and it can be viewed at iom.edu. But at least two of its 25 recommendations to Congress, both unrelated to the complex issue of funding, seem entirely reasonable. They would go a long way toward restoring the appropriate balance at the FDA between expeditiously reviewing new drug applications and ensuring the safety of approved drugs over their life cycle. They would also help dispel the myth among consumers about what FDA approval does and does not mean in terms of a product's risks and benefits.
One would mandate that industry sponsors register all Phase II through IV clinical trials at the National Library of Medicine website (clinicaltrials.gov), wherever they may have been conducted, if data from the trials are intended to be submitted to the FDA as part of a new drug application, supplemental NDA, or to fulfill a post-market commitment. The present system is largely voluntary, and even authors who support it acknowledge that finding Phase IV studies on approved drugs is next to impossible, unless the sponsor chooses to release them, meaning those that found favorable results see the light of day.
A second recommendation would require a symbol on the packaging of a newly approved drug for two years (modifiable on a case-by-case basis should the agency deem it appropriate) indicating its status, and restrict direct-to-consumer advertising during the period that the symbol is in place.
The first recommendation would make vital information available to patients who choose to pursue it. The second would eliminate the vague messaging that characterizes DTC drug advertising from the arena of new drugs, and return the discussion of whether or not to try one to where it belongs—between the doctor and the patient.
