FDA Is Not Following up on Unproven Drugs


Investigators have stated that the Food and Drug Administration (FDA) has permitted certain cancer drugs to stay on the market after follow-up studies demonstrated they didn't extend patients' lives.

The report, which came from the Government Accountability Office also discovered that the FDA will not pull a drug off the market even when such information is more than a decade overdue.

The FDA responded that the report is simply being negative on its "accelerated approval" program, which is only used to approve drugs for the most serious diseases. "Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments," thanks to the program, the FDA said in its response to the report.

In 1992, the FDA found a way to speed up the approval of certain drugs. It was sped up based on so-called “surrogate endpoints”, or “laboratory measures” that implied the drug would help the patient taking it.

Drug makers thought the program was great because it got their drugs on market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars before they could make their hundreds of millions of dollars. However a condition of quicker approval was supposed to be that these drug makers conduct follow-up studies to show the drug's benefits actually panned out.


Sadly, GAO report identified several drugs still on the market that never lived up to their pledge. What’s more, in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to missing or unimpressive follow-up data.

"FDA has fallen far short of where it should be for patient safety," said Sen. Charles Grassley, R-Iowa, who requested the investigation.

"FDA should explain the principles it uses to make decisions such as drug withdrawals," said Principal Deputy Commissioner Dr. Joshua Sharfstein, "but we don't want to lock ourselves into a specific set of criteria that takes away the flexibility to do what's right for the public health."

"The FDA has talked a lot about doing more enforcement, but this is an area where they're basically defending not enforcing the law," said Dr. Sidney Wolf, of the consumer advocacy group Public Citizen.

Wolfe said the lax policy sends a message to companies that there is no penalty for failing to complete studies. "As the scientific experts charged with overseeing the use of drugs it approves, FDA should be in a position to implement this recommendation," the report states. What is clear to the public is the FDA is not following up on unproven drugs allowing it to be sold to the unsuspecting public.

Reference: AP

Written by Tyler Woods Ph.D.
Tucson, Arizona
Exclusive to eMaxHealth