House OKs Compromise Rx Drug Safety, FDA Funding Legislation
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 in the first House bill were "considered more far-reaching than those in the Senate measure," and the new legislation was crafted based on several compromises between the two versions, according to CQ Today (Armstrong, CQ Today, 9/19).
The Senate 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 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.
The bill would give FDA the authority to require pharmaceutical companies to conduct postmarket clinical trials on drugs that have been approved and to impose fines on companies that fail to do so (New York Times, 9/20).
In addition, the legislation would establish a computerized surveillance system to try to identify safety problems with drugs that recently have come on the market. The system would scan insurance and pharmacy claims data to try to identify problems, rather than relying on anecdotal reports from physicians and drug companies, as under the current system (Alonso-Zaldivar, Los Angeles Times, 9/20). In addition, pharmaceutical advertisements would receive closer review by FDA, and the ads would have to include instructions on how to report side effects (Los Angeles Times, 9/20).
The new House bill omits Senate language that would have required FDA approval for label changes if the drug maker discovered a safety issue with the drug. Critics argued it would make it "almost impossible" for consumers to sue drug makers for withholding safety information, according to CongressDaily (Edney, CongressDaily, 9/20). The new House bill states that drug manufacturers have a responsibility to maintain drug labels -- "thus leaving the manufacturers potentially liable if they fail to make changes even without the FDA's explicit approval," according to the Journal (Wilde Mathews, et al., Wall Street Journal, 9/20).
The legislation also would give FDA the authority to force drug makers to change information on product labels and would grant it the power to limit the distribution of certain drugs (New York Times, 9/20).
The compromise bill would grant six months of market exclusivity to drug makers who conduct studies on new pediatric uses of drugs. The original Senate bill would have granted three months of exclusivity (CQ Today, 9/19).
Rep. Henry Waxman (D-Calif.) disagreed with the provision, saying that six months of exclusivity for blockbuster prescription drugs is excessive because drug makers make a "windfall" profit on such medicines at the expense 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).
The original House and Senate bills differed on rules governing conflicts of interest within FDA advisory panels. The House originally called for allowing FDA to issue one conflict-of-interest waiver per advisory panel meeting, while the Senate wanted no limits. The compromise bill requires FDA to determine the number of waivers granted in fiscal year 2007 and then reduce that number every fiscal year by 5% until 2012 (CongressDaily, 9/20).
Under the legislation, drug companies would be required to post publicly the results of all clinical trials pertaining to medications that 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).
House Majority Leader Steny Hoyer (D-Md.) said, "I hope the Senate will move forthwith to approve the bill in order to avoid jeopardizing the jobs of the employees responsible for implementing these critical programs" (Rockoff, Baltimore Sun, 9/20).
Waxman said, "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." Waxman added that he still supports the bill (CongressDaily, 9/19).
Rep. Joe Barton (R-Texas) noted, "No drug is completely safe," adding that the bill strives to "ensure that the balance between benefit and risk remains in equilibrium."
Sen. Edward Kennedy (D-Mass.) said, "This is not a perfect bill, and compromises were made to assure its passage," but "after so many recent instances in which Americans have been harmed by unsafe prescription drugs, ... America cannot afford inaction on this important measure" (Los Angeles Times, 9/20).
House Energy and Commerce Committee Chair John Dingell (D-Mich.) said, "This legislation strikes the proper balance between new drug safety measures and ensuring consumers have access to innovative prescription pharmaceuticals in a timely manner" (CQ Today, 9/19).
Bill Vaughan, a senior policy analyst at Consumers Union, said that the legislation will "save a lot of lives in the long run," adding, "We don't get these kinds of votes every day" (Baltimore Sun, 9/20).
The Times notes that drug makers "largely supported the measure, hoping that a few key concessions ... would increase public confidence in the drug agency and, by extension, their own drugs" (New York Times, 9/20).
Pfizer lobbyist Dolly Judge said that the company believes that the bill "will increase FDA's regulatory authority and hopefully restore people's confidence in the agency and kind of give (FDA) a bigger hammer" (Wall Street Journal, 9/20).
Some observers noted that the 422-page bill is so complicated that it will take some time to digest (CQ Today, 9/19).
Peter Barton Hutt, former FDA general counsel, said, "It's a Christmas tree with more moving parts than you can imagine" (New York Times, 9/20).