A new law has been been proposed to give the FDA authority to recall dangerous drugs. Currently, the FDA can only require warnings, issue safety alerts and recommend that a dangerous drug be recalled. The Drug Safety and Accountability Act of 2010, introduced by Senator Michael Bennet of Colorado, would give the FDA power to recall drugs it determines to be unsafe. “For too long, says Bennet, “the FDA has lacked the proper authority to adequately safeguard our drug supply.”
Most Americans are concerned about drug safety and support increased regulation, according to a new poll released by the Pew Prescription Project. Of those polled, 94% favor giving the FDA recall authority for drugs. In 2009, there were 1,742 drug recalls, 400% more than in 2008. Most of the recalls were related to manufacturing quality and testing.
Drug company lobbyists appear ready to fight the bill, claiming that system to regulate prescription drugs in the U.S. is the safest and most strict in the world.
Some drug safety advocates in favor of the bill are critical of the FDA for not exercising the power it already has to protect the public from dangerous drugs. An example cited is the FDA’s failure to recommend an Avandia recall. The type 2 diabetes drug is believed by some to have caused over 100,000 heart attacks and deaths since it was approved by the FDA.
Safety concerns about Avandia side effects became the focus of public attention earlier this year when a Senate Finance Committee investigation found that drug maker GlaxoSmithKline had evidence of Avandia’s heart attack risks years before it became public. Based on such knowledge, the report stated, GSK had a duty to warn diabetes patients and the FDA of its safety concerns. Instead, the drug company minimized the cardiovascular risks. A 2008 internal FDA Avandia review from the Office of Surveillance and Epidemiology released in the Senate report stated, “We conclude that the cardiovascular risks associated with [Avandia] are excessive…[It] should be pulled from the market.” The agency took no action on the review. In July, a FDA drug safety advisory panel voted against an Avandia recall. It recommended strengthening the warning label and adding new restrictions on the use of the diabetes treatment.