FDA Reform And Concerns For Drug Safety

The Consumer Federation of America, a nonprofit association of 240pro-consumer groups, has urged the Senate to vote against S830, the Food and Drug Administration Modernization and Accountability Act, which it says could allow a flood of unsafe drugs and devices onto the market.

Former Senator and current CFA chairman Howard Metzenbaum told a press conference that the drug and medical device industries have pushed provisions that will undermine the FDA's authority. A set of "so-called" reforms was turned back last year following an outcry by patient and consumer groups, he noted, but this year industry is lucky to need Prescription Drug User Fee Act re-authorization by end-September. The review process outlined in the bill would lower protections for consumers while enriching drug firms, he said; there is nothing in this bill that improves safety or provides further protections for patients. "That's a step backwards. That's retrogressive," he said.

All parties consider PDUFA a success, he said, and approval times have decreased while product safety has remained intact. So now these industry provisions are on a fast-track review because they have been tied to the PDUFA re-authorization.