Deal Struck on FDA Financing
LIANE HANSEN, host:
This is WEEKEND EDITION from NPR News. I'm Liane Hansen.
Congress has sent a bill to President Bush that gives the Food and Drug Administration new funding and new responsibilities. The president is expected to sign the legislation.
NPR's Joanne Silberner explains what the new FDA would mean to drug companies, to the agency itself, and to you.
JOANNE SILBERNER: The legislation is the result of an arm-twisting compromise hammered out just days before major funding for the FDA was about to expire. The final legislation centers on a system whereby drug companies pay several hundred thousand dollars to have a drug considered for approval by the FDA.
In fact, it raises those user fees and then over the next five years, it dedicates $225 million of the new money to raiding heard-over drugs that are already on the market. Consumer advocacy groups lobbied heavily for that extra oversight.
Bill Vaughan senior policy analyst at the Consumers Union is very happy with the way things came out.
Mr. BILL VAUGHAN (Senior Policy Analyst, Consumers Union): This is probably the best improvement in the FDA's legal authority in above 45 years. It's one of those periodic upheavals in legislation that follows disaster in Vioxx - couple other drugs were a disaster.
SILBERNER: Former FDA commissioner Mark McClellan agrees the bill is very important, but he says it's just a start.
Dr. MARK McCLELLAN (Former Commissioner, Food and Drug Administration): The potential is there for some very important benefits but it's going to need to be implemented very effectively in order for that to happen.
SILBERNER: The new law will require the FDA to come up with a system that more quickly and accurately identifies dangerous side effects of drugs that are already on the market. And drug companies are going to have to present clearer details about all the studies they do on the safety and effectiveness of their medicines. That's another provision that consumer advocates like.
Again, Bill Vaughan.
Dr. VAUGHAN: By making the data available and more details about these trials available, we think it'll make the companies a little more honest in this area. And it'll help independent researchers of say that's not good science and we need to take another look at her, or we need to monitor that drug.
SILBERNER: Now you might think drug companies wouldn't like a bill supported by consumer groups and other drug company critics. But manufacturers support the user fees because those fees have dramatically reduced the time it takes the FDA to rule on a new drug. They even say they like the extra safety monitoring.
Caroline Loew is in charge of scientific and regulatory affairs at PHRMA, the drug industry trade group.
Dr. CAROLINE LOEW (Senior Vice President for Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America): From my perspective, anything within harm is FDA's ability to continue to monitor drug safety is something that's very valuable and it's a responsibility that we share with FDA and we take very seriously.
SILBERNER: Then there's the very basis of the bill - the user fees. Jerry Avorn is a professor of medicine at Harvard Medical School and a frequent critic of the drug industry and the FDA. He says pumping in new money to monitor drugs is great.
Professor JERRY AVORN (Medicine, Harvard Medical School): But it is still problematic that the entire funding of the drug approval process still rest so heavily on fees paid for by the drug industry because many people both inside and outside FDA feel that that does make the agency more beholding to the industry that it regulates than it ought to be.
SILBERNER: Bill Vaughan of Consumers Union says that dependency and user fees is something his group will fight when the funding system comes up for renewal in five years.
Joanne Silberner, NPR News, Washington.
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