WASHINGTON WIRE
June 22, 2007
Issue 137
In this issue, you'll find:
Senate Committee Approves Annual Labor-HHS-Education Spending Bill
House Committee Passes Drug User Fee Bill
Stark Considers Changes to Medicare Part D
Top Story
Senate Committee Approves Annual Labor-HHS-Education Spending Bill
On Thursday the Senate Appropriations Committee approved its fiscal year (FY) 2008 spending bill for the Departments of Labor, Health and Human Services (HHS), and Education.
The bill includes $149.2 billion in discretionary spending, which is about $1.9 billion less than the House Labor-HHS-Education Subcommittee and approximately $9 billion more than President Bush requested in his FY 2008 budget.
The Senate legislation would provide the National Institutes of Health with approximately $29.9 billion in FY 2008, nearly $1.0 billion more than last year. The Centers for Disease Control and Prevention (CDC) would receive a $224 million increase under the Senate bill, for a total funding level of approximately $6 billion.
Labor-HHS-Education Subcommittee Chairman Tom Harkin (D-IA) and Ranking Member Arlen Specter (R-PA) included a provision in the spending bill that would make more embryonic stem cell lines available for government research funding. This comes just days after President Bush issued his second veto on embryonic stem cell legislation.
Should this bill reach the President's desk with stem cell provisions, he will almost certainly veto it. However, with or without the stem cell provision, the Bush Administration has also issued veto warnings for any spending bill that exceeds the President' spending request.
Health Care News
House Committee Passes Drug User Fee Bill
The House Energy and Commerce Committee cleared Prescription Drug User Fee reauthorization legislation on Thursday evening and included significant drug safety provisions.
The legislation would reauthorize the Prescription Drug User Fee Act (PDUFA), which allows the Food and Drug Administration (FDA) to garner fees from prescription drug manufacturers to pay for the process of putting new drugs on the market. The legislation would increase drug user fees by $225 million over the five year number that was previously agreed to by the FDA and drug manufacturers. However, an amendment adopted during the mark-up would allow annual spending bills to appropriate additional FDA funding to potentially lower these fees, although several Committee Members doubted the likelihood of additional FDA funding for this purpose.
The Committee-passed bill also reduced from previous drafts the amount in fines that the FDA can impose on companies to $50 million in total and $1 million for initial violations.
The Committee's bill also includes new provisions on post-market drug safety surveillance that allows the FDA to conduct Risk Evaluation and Mitigation Strategy (REMS) on drugs as it finds necessary. (Previous drafts of the legislation would have required FDA to conduct REMS on all prescription drugs.)
As a result of GOP Committee Members' concerns, a provision in the draft legislation that would have prevented federal law from preempting state regulation of drugs was removed.
The legislation would also reauthorize the Medical Device User Fee and Modernization Act (MDUFMA) through which the FDA would collect $287 million over five years in a similar process for the medical device industry.
The full House is not expected to consider the legislation prior to the July 4th Congressional recess.
Stark Considers Changes to Medicare Part D
During a hearing in the House Ways and Means Health Subcommittee this week, Chairman Pete Stark (D-CA) anticipated possible legislation later this summer that would improve the Medicare Part D program for beneficiaries.
The Subcommittee Chairman laid out several potential changes to the prescription drug program including an increase in the oversight authority of the state insurance regulators in terms of marketing drug plans. Congressman Stark also stated interest in codifying a requirement that drug plans cover six categories of therapeutic drugs as well as adding required coverage of benzodiazepines.
Acting Administrator of the Centers for Medicare and Medicaid Services (CMS) testified that the primary outstanding implementation issue for the agency is ensuring accurate premium deductions.
Chairman Stark stated that an interest in many of the potential Part D improvements discussed at the hearing making their way into pending Medicare legislation later this year.
Upcoming Events
Hearings
Tuesday, June 26, 2007
Health Care and the Budget
Senate Budget Committee
9:30 a.m., 608 Dirksen
Review of Actions at Walter Reed
House Armed Services - Subcommittee on Military Personnel
1 p.m., 2118 Rayburn
Wednesday, June 27, 2007
Veterans' Bills
Senate Veterans' Affairs Committee - Mark-up
9:30 a.m., 562 Dirksen
Follow-on Biologics; Brain Trauma; Pending Bills
Senate Health, Education, Labor and Pensions Committee
10 a.m., 628 Dirksen
Doctors and the Drug Industry
Senate Special Aging Committee
10:30 a.m., 106 Dirksen
Thursday, June 28, 2007
Medicare Advantage and the Federal Budget
House Budget Committee
10 a.m., 210 Cannon
Friday, June 29, 2007
Veterans' Benefits Bills
House Veterans' Affairs - Subcommittee on Economic Opportunity - Mark-up
9:30 a.m., 334 Cannon
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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