Senate OKs Compromise Rx Drug Safety, FDA Funding Legislation
The Senate on Thursday by voice vote approved a compromise bill (HR 3580) that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30, the AP/Houston Chronicle reports.
The House on Wednesday approved the bill by a large margin. The legislation now goes to President Bush, who is expected to sign it (Bridges, AP/Houston Chronicle, 9/21).
House and Senate negotiators in the new bill included a number of compromises on provisions that were contained in two versions of reauthorization legislation (HR 2900, S 1082) that passed this summer. If the bill is not signed, FDA on Friday will have to begin to issue dismissal notices for about 2,000 employees.
Under the legislation, the user fees that drug companies pay to FDA to speed approval times would increase about 25% to $400 million. User fees paid by medical device makers also would increase. In addition, the bill includes measures on drug safety, postmarket research, pharmaceutical advertisements, clinical trial disclosures, pediatric trials and conflicts of interest on FDA advisory panels (California Healthline, 9/20).
Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) said, "It's the most important legislation for drug safety I think probably in the history of the country and also includes food safety as well" (Armstrong, CQ Today, 9/20).
HELP Committee ranking member Mike Enzi (R-Wyo.) said, "This bill will meet the challenges of protecting American consumers and patients and usher in a new era of drug safety" (AP/Houston Chronicle, 9/21).
Sen. Tom Coburn (R-Okla.), who placed a hold on the bill that he later lifted, said, "We were locked out of discussions to determine what a final product would look like. Now we are forced to either accept what we do not fully agree with or cause thousands of FDA employees to lose their jobs" (CQ Today, 9/20).
Former FDA Commissioner Mark McClellan said, "This is a different way of doing business for FDA, and there are going to be some real challenges in implementing it effectively." He added, "It's going to shift the focus away from information provided by the drug manufacturers to much broader sources of information in our health care system" (Alonso-Zaldivar, Los Angeles Times, 9/21).
FDA Commissioner Andrew von Eschenbach in a statement said that he is pleased the legislation was approved and that it reauthorizes programs that are "vitally important to the agency and its continued ability to protect and promote the public health."
The Pharmaceutical Research and Manufacturers of America said the measure is a "critical step to make our nation's drug safety system -- which already is the best in the world -- even better" (AP/Houston Chronicle, 9/21).
Dolly Judge, a senior lobbyist for Pfizer, said, "We're really happy with [the legislation]," adding that it should "restore confidence" in FDA's oversight of drug safety (Blum, Bloomberg/Philadelphia Inquirer, 9/21).
Steven Nissen, a Cleveland Clinic heart specialist who identified risks associated with diabetes drug Avandia, said, "It's not a perfect bill -- no legislation is -- but in the key areas, the bill moves us forward toward safer and more effective drugs" (Rockoff, Baltimore Sun, 9/21).
However, Peter Lurie, deputy director of Public Citizen's Health Research Group, said, "The essential problems in drug safety remain unaddressed. It's an enormous lost opportunity" (Bloomberg/Philadelphia Inquirer, 9/21).
Direct-to-consumer advertising was "largely spared" from new restrictions in the legislation, in part because the drug industry has found "powerful allies among media and advertising firms who were determined to protect one of their biggest and fastest-growing advertising categories," the Wall Street Journal reports.
The final bill was "a success for the entire advertising industry," Dan Jaffe, executive vice president of the Association of National Advertisers, said (Wilde Mathews/Kang, Wall Street Journal, 9/21).
Makers of generic drugs "failed to persuade" lawmakers to attach a measure to the legislation that would have established a regulatory pathway for approval of generic biotechnology drugs, the AP/Boston Globe reports.
Some analysts have said the generic drug lobby might not have a legislative vehicle to push for approval of generic biotech drugs in 2008 because no major health care bills are expected to go through Congress.
"Typically, health care legislation does not pass as a stand-alone bill unless there is either enormous political pressure or political consensus," Tony Clapsis, an analyst for Lehman Brothers, said, adding, "When you have conflicting views on an issue, as you do on follow-on biologics at this stage, it's very hard to get a stand-alone bill through Congress" (AP/Boston Globe, 9/21).