Senator to propose creating drug safety office within FDA
Bill likely to be among several seeking reform
US Senator Christopher Dodd will propose legislation to create an office of patient protection reporting directly to the commissioner of the Food and Drug Administration, a move to bolster the safety of prescription drugs after a torrent of worrisome announcements about painkillers and antidepressants eroded consumer confidence.
The Connecticut Democrat's proposal, the first FDA overhaul bill in what's expected to be a crowded field, would charge the new Office of Patient Protection with ensuring the safety of drugs and would request $100 million annually to fund its efforts. The measure also seeks to put the office an arm's length away from an industry-financed division within the FDA that approves new drugs and would offer added regulatory muscle.
The new office would be able to yank an unsafe drug from the market, halt advertising campaigns for unsafe drugs and impose restrictions on the use of drugs.
An FDA spokeswoman declined to comment.
"This is a really interesting development. It seems to have a number of key elements that are needed to ensure drug safety," said Dr. Jerry Avorn, a Harvard Medical School professor and author of "Powerful Medicines."
Authorizing funding and providing a measure of independence for the office are key pluses, Avorn said, "since we've had a problem in the recent past with scientists in the current FDA Office of Drug Safety not feeling that they had the ear of the FDA bureaucracy to demand follow-through on concerns about the safety of approved drugs."
Scott Gottlieb, a resident fellow at the American Enterprise Institute for Public Policy Research, said the $100 million would be better spent shoring up postmarketing safety research done by the agency in traditional and innovative ways. Funding for such high-powered studies that discovered the heart risks of Vioxx amounted to $12.4 million last year.
"That's the kind of stuff David Graham and his group did," Gottlieb said, referring to the FDA whistle-blower. "They would go through those databases and they would use their epidemiological tools to look for signals," said Gottlieb, former FDA director of medical policy development. "If you can give them more resources to do those kinds of studies, I think it would be a very big step in the right direction."
Daniel Troy, former FDA chief counsel, predicted that the provision seeking to halt direct-to-consumer advertising would prove problematic.
"Clearly such a restriction would raise First Amendment issues," Troy said. "Without knowing more about the government's justification for it, it would be difficult to assess whether or not it is actually unconstitutional. But the government would have the burden of proving that this restriction was basically necessary and reasonable."
Marvin Fast, Dodd's spokesman countered: "We think the law in this area is such that questions of health and public safety are the primary questions when looking at corporate speech. While protecting corporate speech is important, protecting the public health should take precedent."
Other lawmakers expected to introduce FDA reform legislation include US Representative Edward J. Markey, Democrat of Malden, and Democratic US Senator Edward M. Kennedy of Massachusetts.
US Senator Charles Grassley, an Iowa Republican whose high-profile hearing on Vioxx made FDA scientist whistle-blower Graham, a household name, in February will introduce legislation to establish an independent office of drug safety that remains within FDA, but outside the control of the Center for Drug Evaluation and Research.
Diedtra Henderson can be reached at dhenderson@globe.com.
