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NEWS AND SPECIAL REPORT |
Marguerite.D.Baxter{at}pharmacia.com
CONGRESS CONVENES A LAME-DUCK SESSION AFTER A REPUBLICAN SWEEP IN THE MID-TERM ELECTIONS
On November 12, 2002, the 107th Congress convened a lame duck session to complete legislative work on the appropriations for fiscal year (FY) 2003, homeland security legislation, terrorism insurance, and the appointment of several judiciary nominees. The House recessed after a 2-day session and is unlikely to return prior to the opening of the 108th Congress in January 2003. The Senate recessed the following week after addressing homeland security issues as well as selecting judicial appointments.
Funding for the operation of the federal government in FY 2003 remains unresolved. The Congress passed a continuing resolution (CR) that will fund the government at 2002 levels through January 11, 2003. The present strategy calls for the new Congress to enact an omnibus appropriations bill the first week of January to complete funding of the federal government through the end of the FY on September 30, 2003. In terms of the funding available for research and innovation, this poses a challenge. Instead of increasing the National Institutes of Health (NIH) budget for the fifth and final year of doubling NIH over five years, the CR operates the NIH at 2002 levels from October 1, 2002 until January 11, 2003. With that said, congressional sources indicate that support for the NIH proposed increase remains strong, and the hope is that when Congress returns in January it will be evident in the omnibus appropriations bill. In the context of the Food and Drug Administration (FDA) this strategy is challenging as the CR contains funding at last year’s level; however, the agency is operating under the new requirements authorized this year under the Prescription Drug User Fee reauthorization. Essentially, the FDA is in a situation where it is required to carry out these mandates without the resources to realize them.
A major provision that was pushed during the Congress failed to be included in the stopgap spending provision—increase of physician payment. During the House of Representatives debate on the issue, Democrats attempted to include this provisions; however, it failed by a vote of 196-218. Physician groups hoped that the CR would be a vehicle for Congress to neutralize a 4.4% reduction in Medicare reimbursements for 2003. The Centers for Medicare and Medicaid have delayed the publication of the final rule due to data problems related to the codes for anesthesiologists. The rule is expected to be published prior to Thanksgiving and will go into effect in February 2003 at the earliest.
LEGISLATIVE OUTLOOK FOR THE 108TH CONGRESS
When the 108th Congress opens in January, the U.S. House of Representatives, the U.S. Senate, and the White House will all be under Republican leadership. As efforts wind down in this Congress, plans are being laid to craft the legislative agenda for the next Congress. In terms of health, there are a number of priorities that are expected to be center stage.
Clinical Trial Oversight
Human subject protections legislation was introduced in the 107th Congress; however, little progress was made in terms of hearings or committee deliberations. It is likely that congressional action will address clinical trials conducted in the U.S. as well as those that are supported by U.S. entities overseas. A number of entities have been scrutinizing inefficiencies and areas for improvement in the oversight of clinical trials. The Pharmaceutical Research and Manufacturers of America has developed a code of clinical trials standards for voluntary compliance by its member organizations. The Institute of Medicine (IOM) issued a report in October entitled "Responsible Research: A Systems Approach to Protecting Research Participants." The report recommends that all research should be conducted under federal regulation through the oversight of a Human Research Participant Protection Program (HRPPP). The report focuses on the roles and responsibilities of HRPPP, and the major portion of the recommendations relate to strengthening the protections of individuals participating in research through enhancing policies and procedures within HRPPP. The IOM is recommending that HRPPPs should replace the current Institutional Review Board (IRB) structure. Further, the IOM recommends that HRPPPs should involve public accountability, bring transparency to the research process, and conduct ethics education programs. The most controversial provision of the IOM report was the recommendation that individuals that are injured in the course of the research should be compensated for their resulting medical expenses as well as their rehabilitation. This will have obvious impact on the cost of the clinical research moving forward.
Medicare Prescription Drug Benefit
With Republican leadership in both houses of Congress as well as the White House, it is widely expected that a Medicare Prescription Benefit will move forward. This past Congress, four separate plans failed to garner the 60-vote majority needed for passage in the senate. It is expected that the House will move a bill similar to the one that was reported out this year. In the Senate it is believed that the starting point is likely to be the "compromise" measure considered this year that combined coverage for low-income seniors with a universal catastrophic benefit. The conventional wisdom is that the Republicans must act on a prescription drug benefit within the first 6-9 months of the next Congress or face severe problems in the presidential election of 2004.
MARK MCCLELLAN SWORN IN AS FDA COMMISSIONER
In early November, Vice President Dick Cheney swore in Mark McClellan, M.D., Ph.D. as Commissioner of the FDA at the White House. Dr. McClellan brings to the position a broad background as a physician and an economist. Previously, Dr. McClellan served as President Bush’s health adviser on the Council of Economic Advisors. He will be taking over an agency that has been leaderless for 22 months, and one that is undergoing significant challenges in terms of recruitment, retention, morale, reorganization of the review functions in the Center for Biologic Review, increasing responsibilities relative to the passage of the Prescription Drug User Fee reauthorization and bioterrorism.
One key area of FDA approvals that may see change during Dr. McClellan’s tenure at the FDA is generic biologics. He indicated in discussions with the Senate that he is open to establishing a generic approval system for biological products. He indicated that the feasibility for considering this should "rely on scientific knowledge and experience as key factors."
FDA TO REVISIT ACCELERATED APPROVAL FOR ONCOLOGY PRODUCTS
The FDA’s oncology division is testing the waters for re-visiting the concept of accelerated approval regulations as they apply to oncology. The division has indicated that issues relative to the limited definition, as well as the structure of clinical development for the agents undergoing the review, need to be considered. The agency believes that it is timely to move toward an emphasis of interim analysis of a surrogate endpoint in a randomized trial rather than relying on nonrandomized phase II trials. The oncology division has granted 11 accelerated approvals through January 1, 2002, and nine of these were based on tumor response in single-arm phase II refractory cancers. They are encouraging a greater use of time to progression rather than tumor response as an endpoint for agents being evaluated under accelerated review.
FEDERAL TRADE COMMISSION TO HOLD HEARINGS ON THE COST OF DRUGS
Timothy Muris, Commissioner of the Federal Trade Commission (FTC) has announced that the FTC and the Department of Justice will hold hearings in 2003 on companies’ disclosure of pharmaceutical costs. The hearings are expected to examine the healthcare marketplace and the role of competition, antitrust, and consumer protection. The FTC is interested in exploring whether there is a broader role for it to play in this economic sector.
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