FDA Needs More Authority and Funds
Citing chronic underfunding for its safety division and the lack of clear regulatory authority, a blue-ribbon panel yesterday released its findings and suggested 25 sweeping changes to the U.S.’s Food and Drug Administration (FDA).
The Washington Post reports
The FDA should reevaluate safety and effectiveness data of such new drugs within five years after initial approval, the panel added, and the agency needs new powers to impose fines and requirements on drugmakers.
To anyone familiar with the drug approval process, these recommendations are not surprising. The process has long emphasized initial safety and efficacy testing, while paying minimal lip service to longer-term effects of drugs it approves.
Sadly, though, the agency responsible for the safety and lives of millions of Americans suffers from the same dysfunctional office politics that affect many large organizations:
[The report] also cited “a lack of collaboration among divisions, tensions [and] inappropriate management” at the FDA, saying officials who focus on safety issues are chronically underfunded compared with those who handle new-drug approvals.
I’m sure this report will do little to boost morale over there. The agency, in full back-pedal spin mode, suggested the report was “out of date” because of changes made in the past year. Yes, they fixed decades of problems in less than a year!
The best recommendation, however, is likely this one:
Manufacturers should also be required to register all clinical trials they sponsor in a government-run database to allow patients and physicians to see the outcome of all studies, not just those published in medical journals, the report said. Studies that show positive results for a drug are more likely to be published by journals than negative ones.
Greater transparency into the clinical trials and drug approval process will ultimately benefit everyone. For instance, does anyone know how many studies exist that are never published that show no drug effects versus the ones that do get published?
What if some companies keep trying for a drug’s approval until they find the right experimental formula that shows positive effects for their drug, and that’s the one study the public sees and gets published? Currently, the public doesn’t know whether this occurs regularly or not. With such a database in place, however, drug studies would become more transparent and we’d be able to answer questions like these.
Here’s the FDA reaction to their commissioned report.
Here’s the report’s briefing paper (the report itself apparently is only available if you purchase it).
Grohol, J. (2006). FDA Needs More Authority and Funds. Psych Central. Retrieved on March 19, 2018, from https://psychcentral.com/blog/fda-needs-more-authority-and-funds/