WASHINGTON WIRE
April 20, 2007
Issue 129
In this issue, you'll find:
Senate Committee Approves PDUFA Legislation
Senate Republicans Filibuster Medicare Drug Negotiation Bill
House Panel Examines Medicare "Inefficiencies"
Top Story
Senate Committee Approves PDUFA Legislation
The Senate Health Education Labor and Pensions (HELP) Committee approved legislation on Wednesday to reauthorize the Prescription Drug User Fee Act (PDUFA).
Drafted by HELP Committee Chairman Edward Kennedy (D-MA), the legislation, which impacts the fees paid by pharmaceutical makers to the Food and Drug Administration (FDA), also includes new drug safety provisions that elicited significant debate during Wednesday's hearing.
The latest draft of the legislation would require a "risk evaluation and mitigation strategy" (REMS) for many pharmaceuticals, tracking the safety of drugs on the market. (Earlier versions required REMS for all new drugs.) However, several Members of the Committee argued that the FDA should decide whether REMS are necessary. Senator Gregg (R-NH) unsuccessfully offered an amendment on Wednesday that would have allowed the FDA to refer potentially harmful drugs to academic institutions where the need for increased surveillance would be determined based on data.
Senator Gregg cited an April 17th letter from the Secretary of Health and Human Services (HHS) stating his concern with the drug safety provisions included Kennedy's legislation.
Although the measure was approved by the Committee, a contentious floor debate appears likely as many GOP lawmakers have openly opposed the measure. Even Senator Roberts (R-KS), who voted for the bill in Committee, stated that unless a subsequent draft loosens some of the restrictions on consumer advertising, he would consider opposing it on the Senate floor.
Chairman Kennedy expects the legislation to reach the Senate floor by June, although other Members anticipate a more aggressive timeline.
The House Energy and Commerce Health Subcommittee also held a hearing this week to examine PDUFA, and the inclusion of drug safety provisions in the user fee reauthorization was a primary topic of discussion. Subcommittee Chairman Frank Pallone (D-NJ) emphasized his interest in seeing more post-marketing drug safety measures and stated that the subcommittee would be holding several related hearings over the next few weeks.
Health Care News and Publications
Senate Republicans Filibuster Medicare Drug Negotiation Bill
The Senate failed to get the necessary votes this week to overcome a filibuster on legislation to allow Medicare to negotiate prescription drug prices.
The legislation, introduced by Finance Committee Chairman Max Baucus (D-MT), would have allowed, although not required, the HHS Secretary to negotiate Medicare prescription drug prices under Part D.
The bill also included provisions to require prioritization of comparative effectiveness studies at HHS, as well as create an HHS advisory commission on comparative effectiveness. Just last week, the Medicare Payment Advisory Commission (MedPAC) approved a draft recommendation encouraging Congress to charge an independent entity to study research on comparative effectiveness of health care services and disseminate that information to stakeholders, including patients and providers.
The Senate bill also aims to increase transparency in Part D drug pricing.
The vote to limit debate on the measure was 55-42 -- five votes short of the 60 votes required. Of note, however, Majority Leader Reid (D-NV), in a procedural move, switched his vote at the end, providing for a possible reconsideration of the bill later this year. Additionally, past supporters John McCain (R-AZ) and Tim Johnson (D-SD) were not present for the vote.
The House approved legislation earlier this year that would have required the HHS Secretary to negotiation drug prices. The President has stated his intent to veto any Part D negotiation legislation.
House Panel Examines Medicare "Inefficiencies"
In a hearing this week, held by the House Energy and Commerce Health Subcommittee, Members examined efficiency in the Medicare system
The Subcommittee heard testimony from the Centers for Medicare and Medicaid Services (CMS) that identified certain Medicare benefits as targets for abusive activities. CMS Acting Administrator, Leslie Norwalk, stated that the "fraudulent business practices of unscrupulous durable medical equipment, orthotics, prosthetics, and suppliers continue to cost the Medicare program billions of dollars."
Also during the hearing, Democrats again expressed discontent with Medicare Advantage (MA) payments, which are approximately 12 percent higher than those provided under the traditional fee-for-service Medicare. With pay-as-you-go rules in place, MA plans appear a prime target for offsetting other healthcare priorities; however, many stakeholders argue that such plans are vital to low-income and rural beneficiaries.
Upcoming Events
Tuesday, April 24, 2007
Global AIDS Assistance Wednesday, April 25, 2007
Living Without Health Insurance Veterans' Mental Health Issues Medicare Trustees Report Thursday, April 26, 2007
Veterans' Health Bills Fiscal 2008 Appropriations: Labor, HHS and Education
House Foreign Affairs Committee
11 a.m., 2172 Rayburn
House Energy and Commerce - Subcommittee on Health
10 a.m., 2123 Rayburn
Senate Veterans' Affairs Committee
2 p.m., 418 Russell
House Ways and Means - Subcommittee on Health
2 p.m., 1100 Longworth
House Veterans' Affairs - Subcommittee on Health
10 a.m., 334 Cannon
House Appropriations - Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
10 a.m., 2359 Rayburn
For More Information
For further information on any topics discussed or publications listed, or to get copies of anything mentioned in this alert, please call 202.466.6550 and ask for the Legislative Practice Group.
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