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Senior Director, Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com
108TH CONGRESS CONVENES
The 108th Congress of the U.S. convened on January 7, 2003. Republicans control the U.S. House of Representatives and the U.S. Senate, as well as the White House. With a "trifecta" in elected leadership the Republicans are eagerly developing a comprehensive agenda to address a broad diversity of priorities.
The Senate GOP leadership has put forward their agenda for the first session of this Congress. Their top priorities include the following:
10TH CONGRESS SETS ABOUT TO WRAPPING UP THE LEGISLATIVE AGENDA OF THE 107TH CONGRESS
Last year, Congress adjourned without completing work on yearlong funding Fiscal Year 03 (FY 03) appropriations. Upon the opening of the 108th Congress, 11 unfinished appropriations bills from last year became the first order of business. Included in these appropriations bills is funding for important health programs including the National Institutes of Health (NIH), Centers for Medicare and Medicaid (CMS), and other programs that fall under the jurisdiction of the Department of Health and Human Services (DHHS).
It is expected that many of the programs under DHHS jurisdiction may be vulnerable to spending cuts as the specifics of these 11 appropriations bills are worked out in the context of an Omnibus Appropriations bill. The White House has successfully convinced the GOP legislators that they need to stick with the $750 billion funding level recommended in the President’s FY 03 budget proposal. Therefore, Congress must complete the 11 appropriations bills within that budget target, making vulnerable key domestic priorities.
Supporters of the NIH have been actively engaged over the past several weeks to urge that Congress not diminish the funding levels for the NIH and complete the fifth and final year of increases to double the NIH budget. At the time this article went to press, Congress had not come to agreement on the final funding levels for the remainder of FY 03, and the actual appropriation for the NIH was not established.
There is a slim possibility that the Medicare physician fee may be addressed as part of the Omnibus Appropriations bill. In the last Congress, the GOP refused to address the physician fee component of the provider issues raised to the Finance and Ways and Means Committees. It was the GOP position then that the physician issue should not be dealt with in isolation of other pressing provider issues. Chairman Grassley (R-IA), incoming Chair of the Senate Finance panel, now has indicated that he believes it would be appropriate to put in place a one year freeze for physician payment under Medicare and that he is seeking opportunities to include such a provision in the Omnibus bill. Essentially, this would keep in effect a 5.4% cut, which occurred in 2002, but prevent a 4.4% reduction in fees that is slated to go into effect in March.
DEBATE ON COMPREHENSIVE MEDICARE REFORM LAUNCHED
The GOP-controlled Congress is working in collaboration with the White House to develop a Medicare Reform proposal that addresses comprehensive reform coupled with access to pharmaceuticals through a prescription drug benefit. While those deliberations are moving forward, the Democrats in the Senate have introduced S. 7, the Prescription Drug Benefit and Cost Containment Act. Senator Tom Daschle, the minority leader, is the lead sponsor of this legislation.
The bill essentially brings together the components of the Democratic agenda that failed to be enacted in the last Congress. The bill includes provisions that would provide a generous Medicare prescription drug benefit; erode patent protection for brand products and disrupt the careful balance struck in the 1984 passage of the Patent Term Restoration Act; allow "Canada only" reimportation of prescription pharmaceuticals; and provide the Food and Drug Administration (FDA) with the authority to statutorily compel drug companies to conduct clinical trails on pediatric populations. The bill lacks any fundamental reform of Medicare and includes numerous provisions that would dramatically alter the business model for the pharmaceutical industry in the U.S.
Last fall, a federal court struck down the Clinton Administration’s final rule compelling manufacturers to conduct pediatric clinical trials on new drugs. In response the Bush Administration indicated that they intended to introduce measures that seek to codify the components of the rule in legislation. Thus, it appears there will be bipartisan support for this aspect of the Democratic proposal.
HUMAN CLONING LIKELY WILL BE DEBATED IN THE 108TH CONGRESS
In the last Congress, issues relative to cloning, both therapeutic and human, were hotly debated in the U.S. House and Senate. No legislative closure was brought to the debate, and it appears likely that cloning will once again be at the forefront of health issues before the 108th Congress.
As a result of concerns over recent media reports regarding purported success in human cloning, Members of the House of Representatives held a press conference on January 8th to highlight a bill they introduced that would outlaw both reproductive and therapeutic cloning. Congressmen Dave Weldon (R-PA) and Bart Stupak (D-MI) have reintroduced the Human Cloning Prohibition Act with more than 75 cosponsors. In the 107th Congress, a similar bill was passed out of the House of Representatives.
The bill has strong support within the Bush Administration; however, its support in the Senate is somewhat unclear due to several key Senators who favor cloning technology support for therapeutic purposes.
PEOPLE AND PLACES
Kathryn Zoon, Ph.D., formerly the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) announced her resignation. She will be returning to the NIH where she will assume a position as the Principal Deputy Director for Research in the Center for Cancer Research at the National Cancer Institute.
Jesse Goodman, M.D., MPH, has been named to replace Dr. Zoon as the Director of CBER. Dr. Goodman, a virologist, was previously CBER’s Deputy Director. He will work closely with Commissioner McClellan and the senior leadership of CBER to support the newly announced integration of product review activities between the CBER and the Center for Drug Evaluation and Research (CDER) at the FDA.
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