Honolulu, Hawaii


Email Wayne Parsons Wayne Parsons on LinkedIn Wayne Parsons on Facebook
Wayne Parsons
Wayne Parsons
Attorney • (808) 845-2211

Why Doesn’t The FDA Follow Untested Drugs?

Comments Off

A report from the General Accounting Office (GAO) questions why the FDA "has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives".

The FDA has an accelerated approval program that applies to serious illnesses that lets drugs on the market to help desperate patients but requires follow up studies.

But the GAO report names drugs that are still on the market apparently after failing to meet the FDA requirements. The question thus lies both with the FDA and with the drug manufactures. This is reminiscent of the Wall Street crisis where government regulators stood by and watched the entire financial system collapse.

According to the AP, the FDA responds that it has "overhauled [its] tracking system since the GAO completed its report." Principal Deputy Commissioner Dr. Joshua Sharfstein said that the FDA does not have a policy for pulling the drugs off the market because "we don’t want to lock ourselves into a specific set of criteria." He "added that the agency has a task force assigned to look at policies like drug withdrawals."