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The Food and Drug Administration (FDA) often — cleverly, but misleadingly — judges its performance using overly simplistic and crude measures, such as the number of new drug approvals and the average time it takes for a pharmaceutical company’s application for a new product to be approved. FDA leaders crow about the agency achieving success when the former number goes up or the latter goes down. But are these meaningful indicators of how well the agency is performing? The answer is a...
The Food and Drug Administration (FDA) often — cleverly, but misleadingly — judges its performance using overly simplistic and crude measures, such as the number of new drug approvals and the average time it takes for a pharmaceutical company’s application for a new product to be approved. FDA leaders crow about the agency achieving success when the former number goes up or the latter goes down. But are these meaningful indicators of how well the agency is performing? The answer is a resounding “no!” except in terms of the satisfaction these results afford to the pharmaceutical industry, the direct funders of the majority of the FDA’s drug review process.
Take, for example, FDA Commissioner Margaret Hamburg’s May 8 commentary on the agency’s website, “Strong Review Performance Brings Innovative Medical Products to Patients.” Hamburg touted the FDA’s “better” performance in reviewing drugs in comparison to its counterparts in Europe and Japan:[1]
[W]e were pleased with new data ... looking at FDA’s review performance for prescription drugs. ...
[W]here the agencies really differed was in drug approval times. FDA’s median approval time in 2013 was 304 days. In Japan it was 342 days, and in Europe it was 478 days. ...
And it turns out that FDA was consistently faster than its regulatory counterparts over the time frame 2004-2013. ...
[O]ur review times certainly benefit from our innovative and flexible approach to drug development and approvals that includes such mechanisms as priority review, fast track designation, and accelerated approval.
The FDA’s obsessive focus on drug approval times is misguided and dangerous, and its self-praise for performing better than its regulatory counterparts abroad based on such statistics is unjustified. Indeed, Hamburg went on to cite as an agency success story the FDA’s recent rapid approval of bedaquiline (SIRTURO) for treating patients with multidrug-resistant tuberculosis. Public Citizen, on the other hand, had urged the FDA not to approve this drug because clinical testing showed a significantly higher mortality rate in patients treated with it. Rapid approval of a drug for which the data show an increase in mortality is not an indicator of success but, rather, of reckless failure.
The agency should shift its criteria for self-evaluation to include critically important factors such as the number of dangerous or ineffective drugs it rejected and the rapidity with which the agency acted to ban approved drugs shown to have unacceptable risks after coming to market. Performance evaluations based on these types of factors ultimately would better protect public health.
References
[1] Hamburg MA. Strong review performance brings innovative medical products to patients. FDAVoice. http://blogs.fda.gov/fdavoice/index.php/2014/05/strong-review-performance-brings-innovative-medical-products-to-patients-2/?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 21, 2014.
