A “conspiracy of silence” is allowing drug companies to abuse the US Food and Drug Administration’s accelerated approval process for their products by failing to conduct the required follow-up studies, according to a report from US congressman, Edward Markey, which also accuses the agency of failing to crack down on the problem.
The accelerated approval process aims to speed up the approval of drugs treating life-threatening conditions, and enables the agency to give the green light on the back of less information than is normally required. However, companies winning the regulatory nod in this manner are required to conduct follow-up post-marketing studies to further highlight the drug’s efficacy. Representative Markey stresses the importance of post-marketing studies by the recent case of AstraZeneca’s non-small cell lung cancer agent, Iressa (gefitinib), which was approved under the “accelerated approval” process back in 2003 [[06/05/03a]]. A follow up study revealed that the drug showed no survival benefit in comparison to a placebo [[20/12/04b]]. Representative Markey questions other companies that have not carried out such follow-up trials could experience similar problems.
The report also highlights that, according to the US Securities and Exchange Commission, 68% of public companies have not disclosed any of their post-marketing study commitments to their shareholders in their SEC filings.
“I will be proposing legislation to address the failures of the drug companies and the FDA to do their due diligence in order to protect patients and doctors across the country,” said Representative Markey, explaining that his bill will require companies to inform patients and doctors when a product has received conditional approval under the accelerated approval system. The legislation also aims to ensure that the FDA has full authority to require further postmarketing studies after a product is already on the market.
