FDA More Partner than Regulator: ProPublica
As a result of prescription drug user fees and company consulting and other payments to doctors who testify before FDA advisory committees, the agency has become more industry partner than regulator, speeding drugs to market faster than any other regulatory agency, according to a lengthy report from ProPublica. “FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease,” the report says. “Once widely assailed for moving slowly, today FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency.”
The report also says Europe has rejected drugs for which FDA accelerated approval, citing Spectrum’s Folotyn, which treats a rare form of blood cancer at a cost of over $92,000 for a seven-week course of treatment. ProPublica says the European regulators cited insufficient evidence of health gains from Folotyn, which shrinks some tumors but hasn’t been shown to extend lives.
The report quotes Public Citizen Health Research Group director Michael Carome that “instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry-friendly perspective.”
The report includes statistics showing that FDA approved 46 novel drugs in 2017, the most in 15 years. At the same time, it says, it is rejecting fewer medications. In 2017, CDER denied 19.7% of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2%.
“Faster reviews mean that FDA often approves drugs despite limited information,” ProPublica says. “It channels more and more experimental treatments … into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two. FDA also increasingly allows drug makers to claim success in trials based on proxy measurements, such as shrunken tumors, instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.”
“Clearly, accelerated approval has greater uncertainty,” CDER director Janet Woodcock told ProPublica. When only a single trial is used for approval, “in some cases there may be more uncertainty about safety findings or with the magnitude of effectiveness.” The report says Woodcock attributed the increased use of expedited pathways to more drug companies developing treatments for rare diseases, “where there’s unmet need, and where the patient populations and providers are eager to accept more uncertainty.”
ProPublica acknowledges that no one wants the agency to drag out reviews unnecessarily and says that even critics say there is no easy way for the agency to strike the perfect balance between sufficient speed and ample information, particularly when patients have no other treatments available, or are terminally ill.