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.