House Approves Prescription Drug User Fee Act Reauthorization

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Prescription Drug User Fee Act Reauthorization

The House on Wednesday voted 405-7 to approve 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 New York Times reports (Harris, New York Times, 9/20). The bill is being "heralded as the most significant drug safety legislation in more than 40 years," according to the AP/Boston Globe (AP/Boston Globe, 9/20).

House and Senate negotiators wrote the legislation based on reauthorization bills (HR 2900, S 1082) that were passed earlier in the summer. The drug safety provisions inthe first House bill were "considered more far-reaching than those inthe Senate measure," and the new legislation was crafted based onseveral compromises between the two versions, according to CQ Today (Armstrong, CQ Today, 9/19).

TheSenate on Thursday is expected to pass the bill, and President Bush"will probably sign the measure quickly," according to the Times.If the bill is not signed, FDA on Friday will have to begin to issuedismissal notices for about 2,000 employees. Under the legislation, theuser fees that drug companies pay to FDA to speed approval times wouldincrease about 25% to $400 million. User fees paid by medical devicemakers also would increase.

Drug Safety

Thebill would give FDA the authority to require pharmaceutical companiesto conduct postmarket clinical trials on drugs that have been approvedand to impose fines on companies that fail to do so (New York Times, 9/20).

Inaddition, the legislation would establish a computerized surveillancesystem to try to identify safety problems with drugs that recently havecome on the market. The system would scan insurance and pharmacy claimsdata to try to identify problems, rather than relying on anecdotalreports from physicians and drug companies, as under the current system(Alonso-Zaldivar, Los Angeles Times,9/20). In addition, pharmaceutical advertisements would receive closerreview by FDA, and the ads would have to include instructions on how toreport side effects (Los Angeles Times, 9/20).

Thenew House bill omits Senate language that would have required FDAapproval for label changes if the drug maker discovered a safety issuewith the drug. Critics argued it would make it "almost impossible" forconsumers to sue drug makers for withholding safety information,according to CongressDaily (Edney, CongressDaily,9/20). The new House bill states that drug manufacturers have aresponsibility to maintain drug labels -- "thus leaving themanufacturers potentially liable if they fail to make changes evenwithout the FDA's explicit approval," according to the Journal (Wilde Mathews, et al., Wall Street Journal, 9/20).

Thelegislation also would give FDA the authority to force drug makers tochange information on product labels and would grant it the power tolimit the distribution of certain drugs (New York Times, 9/20).

Pediatric Safety Trials


The compromise bill would grant six months of market exclusivity todrug makers who conduct studies on new pediatric uses of drugs. Theoriginal Senate bill would have granted three months of exclusivity (CQ Today, 9/19).

Rep.Henry Waxman (D-Calif.) disagreed with the provision, saying that sixmonths of exclusivity for blockbuster prescription drugs is excessivebecause drug makers make a "windfall" profit on such medicines at theexpense of consumers (Cohen, Newark Star-Ledger, 9/20). Waxman said that the profits that result from the period of exclusivity exceed the cost of conducting the new studies (CQ Today, 9/19).

Conflicts of Interest

The original House and Senate bills differed on rules governingconflicts of interest within FDA advisory panels. The House originallycalled for allowing FDA to issue one conflict-of-interest waiver peradvisory panel meeting, while the Senate wanted no limits. Thecompromise bill requires FDA to determine the number of waivers grantedin fiscal year 2007 and then reduce that number every fiscal year by 5%until 2012 (CongressDaily, 9/20).

Clinical Trial Disclosure

Under the legislation, drug companies would be required to postpublicly the results of all clinical trials pertaining to medicationsthat already have been approved (New York Times, 9/20). Administered by NIH, the system would be public and searchable, and it would include information on safety risks (CQ Today, 9/19).

Lawmaker Response

House Majority Leader Steny Hoyer (D-Md.) said, "I hope the Senate willmove forthwith to approve the bill in order to avoid jeopardizing thejobs of the employees responsible for implementing these criticalprograms" (Rockoff, Baltimore Sun, 9/20).

Waxmansaid, "On a number of issues, the movement was to enlist Republicans,but I don't think it was necessary to do what they've done." Waxmanadded that he still supports the bill (CongressDaily, 9/19).

Rep.Joe Barton (R-Texas) noted, "No drug is completely safe," adding thatthe bill strives to "ensure that the balance between benefit and riskremains in equilibrium."

Sen. Edward Kennedy (D-Mass.) said,"This is not a perfect bill, and compromises were made to assure itspassage," but "after so many recent instances in which Americans havebeen harmed by unsafe prescription drugs, ... America cannot affordinaction on this important measure" (Los Angeles Times, 9/20).

House Energy and Commerce CommitteeChair John Dingell (D-Mich.) said, "This legislation strikes the properbalance between new drug safety measures and ensuring consumers haveaccess to innovative prescription pharmaceuticals in a timely manner" (CQ Today, 9/19).

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