New bill seeks to arm FDA with drug recall power

by Olga Deshchenko, DOTmed News Reporter | August 05, 2010
The proposed Drug Safety
and Accountability Act of 2010
would give FDA the power
to recall drugs
A newly proposed bill intends to empower the Food and Drug Administration with the authority to recall potentially dangerous drugs. The Drug Safety and Accountability Act of 2010 was introduced by Colorado Senator Michael Bennet this week.

Currently, the FDA can issue warnings about safety concerns of a certain drug and then recommend that the manufacturer initiate a recall. If the bill passes, the regulatory agency will have the power to recall drugs it considers to be dangerous.

“Making sure pharmaceutical drugs meet the highest standards for safety and quality is important to me, not only as a U.S. Senator, but as the father of three little girls as well,” Bennet said in a statement. “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers. It’s time Washington took action to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harm’s way.”

The bill also seeks to strengthen drug manufacturing standards and closely track their pathway into the U.S. It would require companies to implement quality management plans and mandate more rigorous documentation processes for the origins and handling of imported drugs.

The proposed bill appears on legislators’ desks after a recent recall of Johnson & Johnson children’s medication and the controversy over Avandia, a diabetes drug. In 2009 alone, there were 1,742 drugs recalled, a 400 percent increase from 2008. It was a record year for drug recalls.

Many legislators have expressed concern over the lack of FDA authority over drug regulation. In a letter to the FDA commissioner in May, Iowa Senator Tom Harkin, the chairman of the Senate Committee on Health, Education, Labor and Pensions, asked the agency if “as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply.”

A new poll, released by the Pew Charitable Trust’s Prescription Project, shows that Americans share with legislators concerns about the extent of FDA’s authority. The poll shows that 94 percent of Americans are in favor of giving FDA the authority to recall drugs. In addition, 75 percent of respondents said they have little or no confidence that drugs made in China are free of contaminants and safe for Americans to use.

Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement addressing the safety of drug ingredients from overseas and responding to Bennet's bill.

“The U.S. regulatory system for prescription drugs is the toughest and safest in the world," wrote Ken Johnson, PhRMA's senior vice president. “PhRMA and its member companies have been working with Congressional leaders over the last several years on ideas for making further improvements to the safety of our drug supply. We look forward to reviewing U.S. Sen. Michael Bennet’s bill closely as part of that continuing effort.”

The bill will also provide more FDA oversight for over-the-counter (OTC) drugs.