Negotiators may add FDA overhaul to bioterror bill
House and Senate negotiators are working behind the scenes to attach legislation to the bioterrorism bill to speed new drug reviews and provide more money and employees to the Food and Drug Administration, sources said. But they face a battle from consumer and industry groups that want a piece of the action.
The controversy stems from how Congress will move the Prescription Drug User Fee Act, which requires the drug industry to pay user fees to FDA in exchange for faster review of new drug applications.
The act--which by all accounts has succeeded in bringing more new drugs to market--also has raised concern among consumer groups that new drugs are not receiving adequate scrutiny and could pose more safety problems.
In addition, because it may be the only FDA-related legislation this year, and the first since a major overhaul of the agency in 1997, a host of other interests--including the medical device industry--is pushing to add new items to either PDUFA or its likely underlying vehicle: the bioterrorism bill.
"It's clear that what FDA's feeling is a pressure to approve [new drugs,]" said Ben Peck, legislative representative of Public Citizen, at a press briefing late last week on a proposed PDUFA deal that the drug industry and FDA recently sent to Capitol Hill as the basis for legislation. Consumer groups charge that the PDUFA deal focuses on speedy review rather than drug safety, drains resources away from other FDA priorities and includes too many restrictions on how the money is used.
But the drug industry and FDA point out that the agreement would double the number of employees in FDA's Office of Drug Safety. "From 100 to 200 [employees]--that's a significant step of progress," said a spokesman for the Pharmaceutical Research and Manufacturers of America.
Democratic negotiators said they are working to ensure that the new officers are hired and are attempting to address other concerns about consumer advertising.
The consumer groups also are concerned that the PDUFA measure would pass without much public notice if it is attached to the bioterrorism bill--which is awaiting a House-Senate conference and could be completed in the next two weeks. A formal conference meeting could be convened this week.
On the House side, Energy and Commerce Chairman Billy Tauzin, R-La., and ranking member John Dingell, D-Mich., have said they want a "clean bill" on PDUFA. They have agreed to review medical device reforms--specifically in legislation introduced earlier by Reps. Anna Eshoo, D-Calif., and Jim Greenwood, R-Pa.--at a later date.
On the Senate side, however, Senate Health, Education, Labor and Pensions Committee ranking member Judd Gregg, R-N.H., is pushing for additions to the bill involving medical devices, such as third- party review of new products by outside experts rather than FDA itself.
But a spokesman for Health, Education, Labor and Pensions Committee Chairman Edward Kennedy, D-Mass., declared, "Third-party review falls in the controversial category and is not something the senator can support."
The spokesman said Kennedy would prefer to deal with PDUFA as part of bioterrorism legislation and keep the bill "clean"--but would be prepared to engage in a committee fight or a floor fight, if necessary.
But the device industry says it is only fair to consider their issues, too.
"We defer to the committee leadership about moving the bill, but we're firmly committed to moving it this year," an industry lobbyist said. "There's no way, shape or form that we'll be the skunk of the party."
The possibility of adding user fees for devices is being discussed. But most device firms are not embracing it.
However, other items that are not as controversial--such as creating a new Office of Combination Products at FDA to regulate products that do not fit neatly into existing categories--may be included, sources said.