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Capitol Report

Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com

HUMAN SUBJECTS PROTECTION LEGISLATION LIKELY TO BE INTRODUCED IN THE SENATE

On April 23, 2002 the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on clinical trials. There was uniformity of agreement among the Senators present that legislation to protect human subjects is necessary. In fact, Senators Kennedy (D-MA) and Frist (R-TN) are working together to craft a bipartisan bill, however, they have not reached consensus on several key issues. It has not been determined whether or not the accreditation for human subjects protections programs they are developing should be mandatory (Kennedy) or voluntary (Frist). There is uniform agreement that accreditation should be coupled with federal incentives for institutions to seek accreditation. The incentives that are under consideration include federal funding for clinical research and reduction in oversight of institutional research programs by the government. Other issues that have not been resolved as of yet include reporting requirements for adverse event reporting and the scope of research that will be included in the bill. This component remains open since the sponsors are interested in crafting a bill with the broadest protections for patients, but one that does not have multiple Committee jurisdictions, an issue that could potentially slow consideration and passage once the bill is introduced. In addition, the sponsors apparently have reached agreement that the level of protection provided to a specific clinical research trial should be commensurate with the scope of the risk to the patient.

PHARMACEUTICAL COMPANIES TO PUT CURRENT TRIALS IN FDAMA DATA BANK BY MID-MAY

On March 18th the Food and Drug Administration (FDA) instructed pharmaceutical companies to submit clinical trials information to the public clinical trials data bank within 45 days. This public data bank requirement was included as part of the Food and Drug Administration Modernization Act of 1997. While government-sponsored trials have been entered into this data bank for several years, the Administration has just completed the process for enabling the compliance of the private sector clinical trials. The current deadline is for clinical trials already under way. Any subsequent studies initiated will need to be submitted to the data bank within 21 days after the enrollment date begins. The clinical trial data bank will provide patients with up-to-date information about public and private sector trials. Clinical trial information that will be posted in the data bank includes the following:

• description of the purpose of each experimental drug,
  
• eligibility criteria for participation,
  
• description of the location of trial sites, and
  
• point of contact for those wanting to enroll in the trial.
  

PRIVACY RULE REMAINS FRONT AND CENTER

On March 21, 2002, the White House announced that it was replacing the privacy guidelines drafted by the Clinton administration with new rules. This step was taken after considerable controversy amongst policy makers, Members of Congress, advocates and health care providers/institutions regarding the scope and impact of the original proposal. The Bush Administrations' proposed modifications to the final rule, published in the Federal Register on March 27, 2002, substantially change a number of aspects of the original rule, including relaxing consent requirements. If no Congressional intervention occurs, the final privacy rule will be published later this year and take effect on April 14, 2003.

With that said, the Senate HELP Committee held a hearing and slammed the Administration for this action. Claude A. Allen, deputy secretary of the Department of Health and Human Services (DHHS) appeared as the Administration's witness at the hearing. He defended the action by the Bush Administration to alter the consent requirements, stating that the original proposal would have had a detrimental impact as a result of the unintended consequences on patient care. Members of the Senate are considering legislation to address the actions by the Bush Administration.

PHRMA RELEASES CODE OF CONDUCT FOR INDUSTRY/HEALTHCARE PROFESSIONAL INTERACTIONS

Effective July 1, 2002, the Pharmaceutical Research and Manufacturers of America (PhRMA) membership will voluntarily adopt a code of interaction with healthcare professionals. The code covers interactions with respect to marketed products and relates to pre-launch activities. It does not address relationships with clinical investigators working in collaboration with pharmaceutical companies in clinical trials.

The Code is based upon the premise that a health care provider's care of patients should be based on the patient's medical need. With that said, the Code recognizes the importance of professional relationships with health care providers in the following areas:

• informing health care providers about the benefit and risks of our products,
  
• providing scientific and educational information,
  
• supporting medical research and education, and
  
• obtaining feedback and advice about products through consultation with medical experts.
  

The Code outlines specific standards. Modest meals may be included as part of informational presentations and discussions with industry representatives so long as they occur in a venue and manner conducive to communication and provide educational value. Guests and spouses are not appropriate to be in attendance at these meeting. Financial support for Continuing Medical Education (CME), as well as meals or receptions, should be given to the conference sponsor rather than a speaker. Guidelines for consultants as they relate to reimbursement, travel, lodging, and meal expenses are included. Scholarship and educational funds are permitted under the guidelines so long as the selection of individuals participating is made by the academic or training institution. Educational and practice-related items are allowed so long as they are for the benefit of patients and are not of substantial value ($100 or less). All companies are encouraged to adopt procedures to ensure compliance with this Code.

PHYSICIAN REIMBURSEMENT FORMULA SUBJECT OF WAYS AND MEANS ACTIVITY

Ways and Means Committee Chairman Bill Thomas (R-CA) and Subcommittee Chairwoman Nancy Johnson (R-CT) have written to the Centers for Medicare and Medicaid Services (CMS) Administrator, Tom Scully, regarding calculations of physician reimbursement. In a March letter to Tom Scully, the Members indicated that the 5.4% reduction in physician payments in 2002 is "premised on several actuarial assumptions that are at best open to debate, and at worst, specious." The letter goes on to say that the actual reductions are so out of sync that even if the Medicare payments were to be frozen at current levels the cost to Medicare over the next 10 years would be $40 billion. The Congressmen are concerned that when the planned reductions currently on the books are phased in over the next three years that the physician conversion factor in 2005 will be less than the conversion factor in 1993. They have requested that CMS use administrative authority to correct the errors and rectify the situation.

In addition, in the letter to CMS Administrator Scully they proposed several legislative approaches to alter how physician payments are calculated, and expressed a desire to work with him on these initiatives. They include:

• changing the measure of physician productivity to include a multi-factor productivity measure in lieu of the current model based solely on labor productivity;
  
• revising the assumed behavioral response of physicians to rate decreases; and,
  
• addressing other factors affecting physician income, such as changes in the tax code and adjusting for the steadily increasing professional liability.
  

PRESIDENT NOMINATES HHS OFFICIALS

In the past several weeks the President has announced several health care leaders to fill important vacancies with the Department of Health and Human Services (DHHS). Elias A. Zerhouni, M.D. was nominated and has been confirmed by the Senate as the Director, National Institutes of Health. Dr. Zerhouni served as professor of radiology and biomedical engineering, chairman of radiology and since 1997, Executive Vice Dean of The Johns Hopkins University School of Medicine. During his tenure at Johns Hopkins he was credited with restructuring the School of Medicine's Clinical Practice Association; developing a comprehensive strategic plan for research; playing a leadership role in reorganizing Hopkin's academic medical leadership; and working with policy makers and elected officials to establish a biotechnology research park and urban revitalization project near the Hopkins medical campus.

Richard H. Carmona, M.D., M.P.H. has been selected to serve as the Surgeon General of the U.S. Dr. Carmona served as a Special Forces medic in Vietnam, and received the Bronze Star, a Purple Heart and a Combat Medical Badge. He successfully established the first trauma care system in southern Arizona after graduating at the top of his medical school class from the University of California, San Francisco. He was a professor at the University of Arizona; the CEO of the Pima Health Care System; and served as the Chairman of the state of Arizona Southern Regional Emergency Medical System, as well as a police officer with the Pima County Sheriff's SWAT Team.

Lester M. Crawford, Jr., D.V.M., Ph.D. has been selected to serve as the deputy commissioner of the Food and Drug Administration (FDA), and has taken over as the senior official at the FDA in the absence of a commissioner. Dr. Crawford Center for Veterinary Medicine from 1978-1908, and again from 1982 to 1985.

Marguerite Donoghue Baxter, RN, MN

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