FDA is Slow to Act on Ineffective Drugs, Patients are Put at Risk

When the Food and Drug Administration approves new drugs based on preliminary drug-company estimates of how effective the therapies will be, the agency most often fails to follow up on those claims to make sure they are accurate, according to a new government watchdog report.

The result is that cancer drugs and other medications rushed through FDA approvals are allowed to remain in circulation despite the fact they do nothing to lengthen patients’ lives, relieve their pain, or treat their symptoms.

According to the Government Accountability Office, the FDA has never removed a drug from the market because follow-up investigations found the drug was not as effective as preliminary results claimed, according to an Associated Press report. Also, the FDA has never ordered a drug off the market because a follow-up investigation of the actual benefits has not been done or came back with less than impressive results, says the GAO report set to be released today.

This is all just more evidence of government inefficiency and sloppy work putting patients at risk of dangerous drugs, medical devices, and defective consumer products.

Fast-Tracked Approvals are Not Revisited

Most of the drugs at the center of the controversy have been given fast-tracked approvals intended to get treatments that show promise in treating deadly cancers and other serious conditions to patients as quickly as possible. The FDA defends it so-called “accelerated approval” program and says the faster reviews based on preliminary findings have benefitted “millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments,” the AP said.

The FDA has been granting expedited approval since 1992 to some drugs that have laboratory analysis or other data suggesting they will be effective. Many drugs for fighting HIV, the virus that causes AIDS, have been given approvals based on preliminary findings that they may reduce the power of the virus, which can mean a longer survival rate in people taking the drugs.

Naturally, drug companies love the accelerated approvals because they don’t have to jump through all the hoops required for traditional FDA approvals. That can mean saving millions of dollars in research and development and getting proposed drugs into pharmacies in months instead of years.

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