In an important piece to be published on Wednesday, June 20, 2012 (embargoed until 5:00 PM Tuesday June 19), AEI scholar Scott Gottlieb, M.D., a former Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration (FDA), calls for reform of the agency to remove current obstacles preventing patients from having access to new technologies and continued medical improvements.
Obstacles to innovation:
- The FDA's conflicting responsibilities produce the agency's culture of delay:
- A drug-review culture, which is defined by an excessive desire for certainty. FDA reviewers believe that it is appropriate to prioritize safety over speed. Increasingly, drug-trial requirements are longer, larger, and 'harder to enroll in.
- As a result, the FDA's obligation to guide new medical innovations to market is being neglected.
- The FDA's deepening distrust of doctors who prescribe medicines, and of the companies that market them result in the FDA wanting to regulate – not only how drugs themselves – but also how they are prescribed (off label uses).
- Increasingly the FDA has allowed policy decisions to be made by more junior staff. Having less experience, these junior scientists are less willing to embrace uncertainty.
Solutions:
- A reform of the FDA's responsibilities and structure should improve the agency's harmful review culture.
- The FDA should separate the generation and analysis of scientific data from the policy judgment of the final approval decisions. Weighing data requires judgment.
- Younger FDA reviewers would maintain a tight control over the generation and evaluation of the science involved in reviewing drugs, but the decision process for drug approval should be given to a central committee comprised of the agency's most senior scientists.
While two new pieces of legislation intended to expedite the review of drugs (the TREAT Act and the Advancing Breakthrough Therapies for Patients Act) were passed by Congress recently, the FDA could implement the suggested changes on their own. Gottlieb suggests that Congress, though, should consider a broader restructuring of the agency’s authority.
Scott Gottlieb can be reached at scott.gottlieb@aei.org. For help in reaching him or for other media inquiries, please contact Veronique Rodman at vrodman@aei.org or 202.862.4871.
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