Legislation That Reauthorizes Prescription Drug User Fee Act Approved

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Prescription Drug User Fee Act

The Senate on Thursday by voice vote approved a compromise bill (HR 3580) that would expand FDAoversight of prescription drug safety and reauthorize the PrescriptionDrug User Fee Act, which expires on Sept. 30. The House on Wednesdayapproved the bill by a large margin. The legislation now goes toPresident Bush, who is expected to sign it, the AP/Houston Chronicle reports (Bridges, AP/Houston Chronicle,9/21). House and Senate negotiators in the new bill included a numberof compromises on provisions that were contained in two versions ofreauthorization legislation (HR 2900, S 1082)that passed this summer. If the bill is not signed, FDA on Friday willhave to begin to issue dismissal notices for about 2,000 employees.

Underthe legislation, the user fees that drug companies pay to FDA to speedapproval times would increase about 25% to $400 million. User fees paidby medical device makers also would increase. In addition, the billincludes measures on drug safety, postmarket research, pharmaceuticaladvertisements, clinical trial disclosures, pediatric trials andconflicts of interest on FDA advisory panels (Kaiser Daily Health Policy Report, 9/20).

Comments From Lawmakers, Federal Officials

Senate Health, Education, Labor and Pensions CommitteeChair Edward Kennedy (D-Mass.) said, "It's the most importantlegislation for drug safety I think probably in the history of thecountry and also includes food safety as well" (Armstrong, CQ Today, 9/20).

HELPCommittee ranking member Mike Enzi (R-Wyo.) said, "This bill will meetthe challenges of protecting American consumers and patients and usherin 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 laterlifted, said, "We were locked out of discussions to determine what afinal product would look like. Now we are forced to either accept whatwe do not fully agree with or cause thousands of FDA employees to losetheir jobs" (CQ Today, 9/20).

Former FDACommissioner Mark McClellan said, "This is a different way of doingbusiness for FDA, and there are going to be some real challenges inimplementing it effectively." He added, "It's going to shift the focusaway from information provided by the drug manufacturers to muchbroader sources of information in our health care system"(Alonso-Zaldivar, Los Angeles Times, 9/21).

FDACommissioner Andrew von Eschenbach in a statement said that he ispleased the legislation was approved and that it reauthorizes programsthat are "vitally important to the agency and its continued ability toprotect and promote the public health."

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Additional Reaction

The Pharmaceutical Research and Manufacturers of Americasaid the measure is a "critical step to make our nation's drug safetysystem -- 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 itshould "restore confidence" in FDA's oversight of drug safety (Blum, Bloomberg/Philadelphia Inquirer, 9/21).

Steven Nissen, a Cleveland Clinicheart specialist who identified risks associated with diabetes drugAvandia, said, "It's not a perfect bill -- no legislation is -- but inthe key areas, the bill moves us forward toward safer and moreeffective 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 Largely Unaffected

Direct-to-consumer advertising was "largely spared" from newrestrictions in the legislation, in part because the drug industry hasfound "powerful allies among media and advertising firms who weredetermined to protect one of their biggest and fastest-growingadvertising 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).

Generic Biotechnology Drug Provisions Not Included

Makers of generic drugs "failed to persuade" lawmakers to attach ameasure to the legislation that would have established a regulatorypathway for approval of generic biotechnology drugs, the AP/Boston Globereports. Some analysts have said the generic drug lobby might not havea legislative vehicle to push for approval of generic biotech drugs in2008 because no major health care bills are expected to go throughCongress.

"Typically, health care legislation does not pass asa stand-alone bill unless there is either enormous political pressureor political consensus," Tony Clapsis, an analyst for Lehman Brothers,said, adding, "When you have conflicting views on an issue, as you doon follow-on biologics at this stage, it's very hard to get astand-alone bill through Congress" (AP/Boston Globe, 9/21).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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