By Chris Thomas, Contact

August 4, 2010

SEATTLE - A new bill introduced in the U.S. Senate on Tuesday could give the Food and Drug Administration (FDA) greater power to recall potentially unsafe prescription and over-the-counter drugs. Last year, there were more than 1,700 drug recalls, four times more than the previous year.

Seattle attorney Maria Diamond handles drug-related injury cases. She says the additional authority is needed partly because it is difficult to track problems when most drug ingredients are not made in the United States.

"The problem becomes that much worse in the context now, as we're seeing more and more products being made overseas, where there is no oversight and little if any quality control. And we've certainly seen that in a number of products from China, most recently."

The Drug Safety and Accountability Act would give the FDA authority to subpoena documents and witnesses, and to assess civil penalties. It was introduced on the heels of some high-profile voluntary recalls this year, including one involving Children's Tylenol. Diamond says a lack of funding has limited the FDA's enforcement powers — and the drug industry is not always willing to speak up quickly when a problem is suspected.

"One of the most important things civil litigation does is brings to light all of the evidence, in terms of what drug companies knew and when they knew it. And it has been through the process of civil litigation that some of the 'worst of the worst' have come to light."

Diamond believes the legislation is a good idea, although she notes the FDA and drug manufacturers historically have had close ties, and thinks precautions should be taken to keep consumer safety first.

A new Pew poll also shows overwhelming public support for tougher safety laws for consumer drugs, according to Allan Coukell is director of the Pew Prescription Project.

"In the current environment, I don't think it's an automatic given that Americans across the political spectrum would support increased authority for a federal agency, and so I think it's striking that we see that finding."

In response to the new legislation, the leading pharmaceutical industry group says the U.S. already has the toughest and safest drug regulatory system in the world.

Best Practices