GAO Report Reveals that FDA is Failing on Forcing Drug Makers to Prove Drugs Work

David Mittleman

Attorney
(866) 735-1102 Ext 430

0 CommentsPrint ArticleSubscribe

According to a Government Accountability Office report released on Monday, between 1992 and 2008, the Food and Drug Administration asked pharmaceutical drug makers to complete 144 studies associated with 90 applications waiting for approval. However, drug makers only completed 2/3 of the requested studies. Overall, the study indicates that serious problems still exist: federal drug regulators have repeatedly failed to force drug makers to comply with FDA requests to prove that their pharmaceutical drugs work. This is particularly problematic for patients, who remain uninformed about whether or not their medications are actually beneficial.

In fact, concerns over the FDA’s ability to prompt drug makers to complete requested studies reached such a crescendo, that Congress passed a law in 2007 giving the FDA greater power in enforcing such rules. Since that law passed, the FDA can fine drug makers if they fail to follow through with promised studies.

All of the 90 applications cited in the recent GAO report were submitted to the FDA under a program that expedites the approval process for life-threatening conditions like cancer or HIV/AIDS. Under the accelerated-approval program, the FDA often approves medications that may or may not be beneficial in treating these diseases. However, after a drug is approved through the expedited process, the drug maker is supposed to conduct confirmatory trials to prove that the drug is beneficial. Nevertheless, the process is still risky: some patients may benefit from a drug. On the other hand, the most vulnerable could also suffer needlessly from the side effects of a medication, while experiencing very little improvement in their condition. In response to the recent GAO report, the FDA’s principal deputy commissioner has promised that the agency is overhauling their tracking system and that the problem will be fixed.