Senate Approves Prescription Drug User Fee Act Reauthorization Bill That Includes Post-Market Safety Provisions

Main Category: Pharma Industry / Biotech Industry
Article Date: 14 May 2007 - 10:00 PDT

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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 (Kaiser Daily Health Policy Report, 5/8).

The legislation includes a number of prescription drug safety provisions, 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.

Preceding the approval of that amendment, 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 (Kaiser Daily Health Policy Report, 5/8).

Amendments
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).

Additional Amendments
The Senate voted 47-46 to reject an amendment proposed by Grassley that would have allowed FDA prescription drug safety staff to share authority with the agency reviewers. The Senate voted 47-47 to reject an amendment proposed by Sen. Richard Durbin (D-Ill.) that would have revised conflict-of-interest rules for medical experts who participate on FDA advisory committees. The amendment would have limited advisory committees to one waiver of the rules (CongressDaily, 5/9).

Comments
Senate HELP Committee ranking member Mike Enzi (R-Wyo.) said, "Right now the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market. This bill will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans" (AP/San Francisco Chronicle, 5/10).

Kennedy said, "This legislation (will) bring [FDA] into the 21st century. It greatly improves the way the FDA oversees the safety of drugs. ... When patients are in danger, the FDA should not have to wait to get legal opinions ... to protect health" (Alonso-Zaldivar, Los Angeles Times, 5/10).

Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, said that the group is "generally pleased" with the bill but added that "you don't want to overwhelm with regulatory requirements" (Wall Street Journal, 5/10). Sen. Bernie Sanders (I-Vt.), the only senator to vote against the legislation, criticized the lack of provisions to allow reimportation and limit the amount pharmaceutical companies can spend on ads. He also criticized a provision in the bill that would allow FDA to regulate medical marijuana as the agency regulates legal mediations. Sanders said, "Safe drugs are obviously important, and there are a lot of good provisions in this bill." He added, "But a safe drug doesn't mean anything to somebody who can't afford it" (Lee, Washington Post, 5/10).

Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The bill's improvements in FDA authority are important but inadequate. The bill would increase collaboration between the agency and the drug industry by increasing the agency's reliance on user fees to finance drug reviews" (New York Times, 5/10).

House Hearing
Lawmakers at a House Energy and Commerce Health Subcommittee hearing on Wednesday said that FDA should have more authority and resources to monitor the safety of new medications, CQ HealthBeat reports. At the hearing, one of several the committee plans to hold as the House prepares to consider legislation that would reauthorize PDUFA, subcommittee Chair Frank Pallone (D-N.J.) said that FDA should have the authority to require pharmaceutical companies to conduct post-market studies of new medications. He said, "The results of these clinical trials contain valuable information for patients and their physicians, and we should demand that they be made available."

Some witnesses at the hearing recommended the establishment of a separate Office of Drug Safety within FDA. However, Caroline Loew, senior vice president of scientific and regulatory affairs for PhRMA, said lawmakers should avoid reforms of FDA that would limit innovation or patient access to medications (Carey, CQ HealthBeat, 5/9). 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).

Government Accountability Office testimony from the hearing is available online. Note: You must have Adobe Acrobat Reader to view the report.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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