House Approves Bill To Overhaul FDA, Boost Safety of Rx Drugs
The House on Wednesday voted 403-16 to approve a bill that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 7/12).
FDA has proposed that pharmaceutical companies pay $393 million in user fees in 2008. The legislation calls for an additional $225 million in user fees from pharmaceutical companies over five years. In addition, the bill would reauthorize the Medical Device User Fee and Modernization Act, which also expires on Sept. 30. FDA would receive about $287 million in user fees from medical device companies over five years.
The legislation would allow FDA to require pharmaceutical companies to conduct postmarket safety studies of new medications, limit distribution of certain treatments and order product label changes.
FDA could fine pharmaceutical companies as much as $250,000 for a single violation of the requirements and as much as $1 million for several violations. In the event that pharmaceutical companies do not address the violations after they receive notice from FDA, the agency could fine them as much as $10 million for a single violation and as much as $50 million for several violations.
In addition, the bill would allow FDA to require new medications to enter postmarket risk-mitigation plans. FDA also could review and recommend changes to direct-to-consumer advertisements for new medications and could require disclosures in potentially false or misleading ads.
The legislation also would establish prescription drug safety requirements for FDA. Under the bill, FDA would have to report to Congress in cases in which recommendations for agency safety reviewers are not accepted.
The legislation also would establish a "unique identifier number" for all medical devices that would allow FDA and health care providers to track the devices for potential problems (California Healthline, 6/22).
The bill allows FDA to approve generic versions of medications regardless of whether manufacturers of the brand-name versions raise safety concerns or other issues (Edney, CongressDaily, 7/12).
House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) said, "Over the past few years, it has become clear that consumers have been placed in harm's way because of the failings of the public health system" (Los Angeles Times, 7/12). He added, "The legislation will lay the groundwork for restoring public confidence in the FDA by giving it the tools it needs to safeguard the public health."
The Pharmaceutical Research and Manufacturers of America said that the legislation "will preserve -- and even strengthen -- the FDA's ability to do its job."
PhRMA President Billy Tauzin said, "Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous standards in the world today" (Cohen, Newark Star-Ledger, 7/12).
The legislation moves to conference committee to reconcile differences with a similar bill (S 1082) approved by the Senate in May.
According to the Times, the House version of the legislation "follows the same basic approach to safety as the Senate version" but "would give the FDA stronger regulatory powers in some areas."
Both versions of the bill include a provision that would establish a computerized network to scan public and private health insurance and pharmacy records for indications of safety issues with new medications, but the House version does not include benchmarks for implementation of the network in the Senate version (Los Angeles Times, 7/12).
The House and Senate versions of the legislation also differ on the number of FDA advisory committee members with financial conflicts of interest who could receive exemptions, and the "fines in the Senate bill are much smaller," CQ Today reports (Armstrong, CQ Today, 7/11).
The House version of the bill does not include a provision in the Senate version that would allow FDA to approve generic versions of biotechnology medications.
Pallone on Wednesday said that members of the conference committee would consider such a provision in the final version of the bill in the event they can reach a consensus. "I don't want to be too positive," Pallone said (CongressDaily, 7/12).
House Energy and Commerce Committee Chair John Dingell (D-Mich.) said that he does not support such a provision in the final version of the legislation. "There's really no record to justify that kind of action" for the House, which has not debated legislation that would allow FDA to approve generic versions of biotech medications (Wilde Mathews, Wall Street Journal, 7/12).
According to the Times, whether President Bush would veto the final version of the bill remains "unclear," as the administration has "said it agreed with the goals of the legislation but had serious concerns about aspects of the risk plans."
The administration also has said that the final version of the legislation should not include a provision to allow FDA to approve generic versions of biotech medications (Los Angeles Times, 7/12).
Pallone said that he expects the conference committee to begin negotiations almost immediately (CongressDaily, 7/12).