50% of Fast-Track Approved Drugs – Mostly Cancer Drugs – Have Not Been Proved Effective After 3 Years on the Market!
The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations.
The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval.
Furthermore, 44 percent of such trials were not the placebo-controlled variety considered to be the gold standard but rather relied on the same surrogate measures used to win a quick approval, leaving each drug’s true value unclear. This was particularly striking for cancer drugs, accounting for 80 percent of studied approvals, which were cleared based on how well they shrank tumors, not how long they kept patients alive.
Further Reading:
- “GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks!”; http://sco.lt/89j3Zp
- "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY
According a Research Letter published in the July 10, 2013, issue of JAMA. The authors of the study found that NONE (zero) of the 865 studies under FDAAA jurisdiction from 2008 through 2011 have been completed. Of the 387 studies mandated in 2011, 271 (70%) have not even begun.