Former FDA Official Outlines Needed Improvements at Agency
A former FDA official is calling out the agency over a couple of recent approvals that he says defy common sense and lack scientific proof that they are safe and effective. Writing in a Stat News opinion piece, former FDA medical officer and now Georgetown University pharmacology professor David Gortler questions how Sprout Pharmaceutical’s Addyi (flibanserin) for treating hypoactive sexual desire disorder in premenopausal women and Sarepta’s Duchenne drug Exondys 51 (eteplirsen) won approval with minimal efficacy data. He also offers seven suggestions on how to improve FDA.
For one, FDA has a hiring process that he says is broken and hampers the agency from hiring top qualified staff members. “Part of the problem is a broken hiring system through USAjobs.com, where all applications must initially be submitted,” Gortler writes. “There, human resources managers with little or no scientific training review the applications of highly specialized scientists. To make matters worse, it’s impossible for the best and brightest in academia and industry to directly call a recruiter at the FDA, because there is no publicly available list of FDA recruiters.”
Next, Gortler says there should be consequences for bad decisions. He appears to take an indirect stab at CDER director Janet Woodcock, and commissioner Robert Califf for supporting her decision in the controversial approval of eteplirsen. Woodcock overruled lower level reviewers to allow marketing of the therapy. “Some FDA staffers in powerful positions make bad decisions, or have views that aren’t in line with mainstream, evidence-based science,” Gortler writes. “Directors, deputy directors, or others should be held directly accountable when they incorrectly approve a drug, unnecessarily hold up approval of one, or implement bad decisions, just as would happen in private sector jobs. Unfortunately, most of what happens in internal FDA meetings is never made public, so it is often difficult or impossible to hold individuals accountable.”
Presumably to prevent another eteplirsen-like approval, which many insiders and outsiders say has lowered approval standards at FDA, Gortler believes that new product reviewers “should have the option to contact an outside group of scientists — possibly a congressionally appointed committee” when internal approval disagreements occur. Currently, in most situations when management (who did not conduct the review) disagrees with the in-the-trenches reviewer, that reviewer currently has no recourse except to obey his or her supervisor.”
Next, Gortler takes aim at FDA’s “poor job” of collecting and monitoring adverse event reports. “Adverse event tracking through the FDA Adverse Event Reporting System (FAERS) or MedWatch has the power to provide valuable real-time sharing of new drug safety issues that did not emerge during clinical trials,” he says. “Unfortunately, the time-intensive process of reporting an adverse event to a drug company or the FDA is neither a requirement nor goal for prescribers, physicians, and pharmacists who are already burdened with overwhelming amounts of paperwork for insurance companies, Obamacare, and electronic medical record requirements.”
Additionally, Gortler says FDA should play some role in helping keep drug prices in check. “Congress should create an offshoot of the FDA similar to the United Kingdom’s National Institute for Health and Care Excellence,” he says. “It independently reviews and recommends drugs within the same class, based on their safety, efficacy, and overall merit and benefit. This is something we could definitely learn from the FDA’s European counterpart, the European Medicines Agency.”