WASHINGTON WIRE
May 11, 2007
Issue 132
In this issue, you'll find:
Senate Approve Drug, Device User Fee Reauthorization
Conferees Begin Budget Negotiations
Compartive Effectiveness Efforts Gains Momentum
Top Story
Senate Approve Drug, Device User Fee Reauthorization
On Wednesday, the Senate voted 93-1 to approve legislation to reauthorize drug and device user fee programs. Senator Bernard Sanders (I-VT) was the only Member to vote against the measure.
The bill would provide the Food and Drug Administration (FDA) approximately $450 million in fees from the pharmaceutical and device industries. Drug safety provisions included in the bill would allow greater post-market surveillance and implement a new risk evaluation and mitigation strategy (REMS). Senate Finance Committee Ranking Member Charles Grassley (R-IA) successfully offered a last minute amendment that would increase the civil monetary penalties on drug companies for drug safety violations.
Senator Byron Dorgan (D-ND) also successfully offered an amendment that would allow drug importation from Canada and 30 other countries in an attempt to lower drug costs for many Americans. However, Senator Cochran (R-MS) also successfully offered a related amendment that would require the government to certify the safety of imported drugs. Because this Administration, as well as previous ones, is unable to certify the safety of imported drugs, Senator Cochran's amendment essentially negates Senator Dorgan's.
In the House, Members plan to move the drug user fee and medical device user fee reauthorization bills separately and it remains unclear whether it will be merged with the drug safety legislation. However, with a September 30th deadline looming, at which time the drug user fee program will expire, the House is hoping to mark-up that legislation by early July.
Health Care News
Conferees Begin Budget Negotiations
House and Senate conferees began work on finalizing a fiscal year (FY) 2008 budget resolution on Wednesday evening.
The Congressional budget resolution serves as a blueprint for discretionary spending later established in the appropriations process.
As it currently stands, the House budget would provide nearly $7 billion more than the Senate budget in discretionary spending. Negotiators also have to decide how to handle expiring tax cuts and whether to include reconciliation instructions to the House and Senate education committees regarding higher education reauthorization legislation. However, the appointment of Senate conferees indicates that Members are close to a compromise on these issues.
House and Senate leaders hope to have a conferenced resolution on the House and Senate floors by early next week.
Comparative Effectiveness Efforts Gains Momentum
Studying and comparing the effectiveness of pharmaceuticals, devices and services ("Comparative Effectiveness") became an increasingly popularly subject on Capitol Hill this week.
Congressman Tom Allen (D-ME) and Congresswoman Jo Ann Emerson (R-MO) have introduced legislation that would provide the Agency for Health Research and Quality (AHRQ) with $3 billion over five years to expand on comparative effectiveness research. The bill would also create an independent advisory board to set research priorities and recommend future research activities. To fund this, the legislation would require insurers, both public and private, to contribute to a "Comparative Effectiveness Trust Fund." Senator Hillary Clinton (D-NY) stated this week that she plans to unveil a Senate proposal on comparative effectiveness in the near future.
Additionally, the Blue Cross Blue Shield Association (BCBSA) urged Congress this week to establish an independent institute to fund comparative effectiveness research. BCBSA stated that the institute would require approximately $500 million in its first year.
Many lawmakers and insurance companies support comparative effective research as a means of improving health care quality and potentially decreasing costs. In fact, Senator Max Baucus (D-MT), Chairman of the Senate Finance Committee, said in a statement this week that Congress should move on this important issue this year. However, supporters are up against the powerful pharmaceutical and device manufactures who fear that comparative effective research will turn into a basis for price and coverage by insurers.
As of now, House Energy and Commerce Committee Chairman, John Dingell (D-MI), has no plans to mark-up Congressman Allen's legislation.
Upcoming Events
Hearings
Tuesday, May 15, 2007
Alzheimer's Research
Senate Health, Education, Labor and Pensions Committee
10 am, 628 Dirksen
Medicare Payments for Hospitals, Home Health and Skilled Nursing
House Ways and Means - Subcommittee on Health
2 pm, 1100 Longworth
Medicare Savings Plan and Low Income Subsidy
House Energy and Commerce - Subcommittee on Health
2 pm, 2123 Rayburn
Wednesday, May 16, 2007
Medical Device User Fee and Modernization Act
House Energy and Commerce - Subcommittee on Health
10 am, 2322 Rayburn
Mine Safety and Health
House Education and Labor Committee
10:30 am, 2175 Rayburn
Thursday, May 17, 2007
Safety of Food Supply
House Energy and Commerce - Subcommittee on Oversight and Investigations
9:30 am, 2123 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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