U.S. Senate Approves Bill on FDA Payments, Rx Drug Safety
The Senate on Wednesday voted 93-1 to approve a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 5/10).
The legislation, which the Senate Health, Education, Labor and Pensions Committee approved in April, would reauthorize PDUFA through 2012.
The bill, sponsored by committee Chair Edward Kennedy (D-Mass.), in large part follows a proposal that FDA submitted to Congress earlier this year under which pharmaceutical companies would pay the agency about $393 million in user fees in fiscal year 2008, compared with $305 million in FY 2007. The legislation increased the amount in the proposal by $50 million. According to the Congressional Budget Office, the bill would cost $547 million over five years (California Healthline, 5/8).
The legislation includes a number of prescription drug safety measures, such as 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 (Alonso-Zaldivar, Los Angeles Times, 5/10).
The Senate on Monday by voice vote approved an amendment proposed by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) that would allow prescription drug reimportation from other nations.
However, before the vote, the Senate voted 49-40 to approve a second-degree amendment proposed by Sen. Thad Cochran (R-Miss.) that would not allow reimportation until the HHS secretary certifies the practice would "pose no additional risk to the public's health and safety" and significantly would reduce costs for consumers. The approval of the Cochran amendment effectively nullified the Dorgan amendment because HHS secretaries in the current and previous administrations have refused to certify the safety of reimportation (California Healthline, 5/8).
Before the passage of the bill, the Senate voted 64-30 to approve an amendment that would increase the minimum civil fine FDA could impose on pharmaceutical companies for failure to comply with agency requests for label revisions or additional studies of medications from $10,000 to $250,000 and the maximum fine from $1 million to $2 million (Wayne, CQ Today, 5/9).
Sen. Chuck Grassley (R-Iowa), who proposed the amendment, said, "If fines are nothing more than the cost of doing business, you cannot deter bad behavior" (Pear, New York Times, 5/10). He added, "The civil monetary penalties that were in the bill didn't pack enough punch to get the attention of corporations" (CQ Today, 5/9).
The Senate also approved an amendment to replace a provision in the bill that would have allowed FDA to require pharmaceutical companies to wait two years before they air advertisements for new medications with a provision that would allow the agency to fine companies for false or misleading ads. Under the provision, the fines would total $150,000 for a first offense and $300,000 for additional offenses (Edney, CongressDaily, 5/9).
Sen. Pat Roberts (R-Kan.), who proposed the amendment, said the replaced provision would have violated the First Amendment rights of pharmaceutical companies. "My key concern with the underlying bill is the recognition that the ban on free speech is based on what the FDA does not know, not what it knows," Roberts said, adding, "In other words, the government would ban free speech even though it cannot identify an adverse event to support the ban."
However, Bill Vaughan, a policy analyst for Consumers Union, said, "When a company can make more than a million dollars a day in drug sales, a $150,000 fine for running a misleading advertisement won't have much impact" (Lopes, Washington Times, 5/10).
The House is working on its own version of the bill, which appears to have broad support (Norfolk Virginian-Pilot, 5/10).
According to the Los Angeles Times, the House version of the reauthorization bill "is likely to be tougher on industry, but senior House lawmakers have praised the Senate's basic approach" (Los Angeles Times, 5/10).
President Bush is not expected to veto the bill (Norfolk Virginian-Pilot, 5/10).