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NEWS AND SPECIAL REPORTS |
Senior Director, Pharmacia Corporation
CANCER DRUG DEVELOPMENT PATIENT CONSULTATION PROGRAM ESTABLISHED BY THE FOOD AND DRUG ADMINISTRATION
The Food and Drug Administration (FDA) has established a new program, the Cancer Drug Development Program, to integrate the perspective of patient advocates in the FDA's drug review regulatory process. The FDA has selected 23 individuals, representing patient survivors, parents, caretakers, friends, and cancer professionals, to serve in this capacity. The cancer patient advocates will participate directly in FDA activities relative to product regulation. Specifically, the FDA will match a specific cancer and its advocate to a proposed indication of a new cancer drug being considered by the FDA and integrate the advocate in FDA-related activities. The patient consultant will participate in meetings, by telephone, between the FDA and pharmaceutical companies. Participation in this manner is required by outside scientific/clinical consultants to the FDA during the drug development phase of its efforts. The FDA has established a two-day training program for the patient advocates selected. The training will include the following: workshop at the FDA providing an overview of the FDA, the drug review process, the patient consultant's obligations under the conflict of interest and confidentiality regulations; a site visit to the Division of Oncology Drug Products; and, an FDA employee mentor for ongoing training, support, and problem solving.
CONGRESSWOMAN DEBORAH PRYCE (R-OH) TAKES THE INITIATIVE ON CANCER
On March 8th, Congresswoman Deborah Pryce (R-OH) introduced the Access to Cancer Clinical Trials Act of 2001. The legislation would amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require individual health insurance coverage and group health plans to provide coverage for individuals participating in approved cancer clinical trials. The legislation was referred to the Committee on Energy and Commerce, the Committee on Education and the Workforce, and the Committee on Ways and Means for review and consideration. Upon introduction, the legislation had four cosponsors: Congressman Ken Bentsen (D-TX), Congresswoman Carolyn Maloney (D-NY), and Congresswoman Sue Myrick (R-NC). The legislation mirrors the language in the Patient's Bill of Rights that has been introduced and debated in the 106th and 107th Congresses. The legislation outlines approved clinical trials that would be included in the scope of the bill, specifies the scope of items to be covered, and establishes payment specifications among other items.
On April 26th Congresswoman Deborah Pryce (R-OH) introduced the Access to Cancer Therapies Act to address the issue of oral cancer chemotherapy in Medicare Part B. About 90% of drugs used to treat people with cancer have been covered by Medicare thus far since they are injected by a health care provider under the supervision of a physician or are "incident to" services by providers which are covered. In 1993 the statutes covering Medicare were extended to include select self-administered drugs so long as they were available in an injectable form that would be reimbursable under Medicare. However, with the shift to molecular and targeted therapies it is clear that cancer pharmacological management will include a shift to oral therapies. If enacted, the Access to Cancer Therapies Act will augment existing Medicare policy to cover all anti-cancer drugs, oral, and injectable, for Medicare beneficiaries. In the House the legislation was co-sponsored by the following Congressmen: Ken Bentsen (D-TX); Lois Capps, (D-CA); Sue Myrick, (R-NC); Roy Blunt (R-MO); Bob Ehrlich (R-MD); Mark Foley (R-FL); Tony Hall (D-OH); David Hobson (R-OH), and Vic Snyder (D-AR). Senators Olympia Snowe (R-ME) and John D. Rockefeller (D-WV) have introduced this bill in the U.S. Senate.
There have been no hearings or actions taken by the committees of jurisdiction on either of these important legislative proposals as of this writing.
CLINICAL TRIALS ISSUES REMAIN IN THE FOREFRONT
U.S. Senate
It is anticipated that Senators Kennedy (D-MA) and Frist (R-TN) are expected to introduce legislation addressing the protection of human subjects involved in clinical research. When proposed the legislation is expected to follow up on issues and testimony presented to the Senate HELP Committee in the last Congress regarding human subject protections. At press time there was no draft of the legislation available for review. It is widely believed that the legislative proposal will address issues raised in recent National Bioethics Advisory Commission (NBAC) and Institute of Medicine (IOM) reports regarding human subject protections and clinical research which have been released during the past year.
National Bioethics Advisory Commission
On April 18, the National Bioethics Advisory Commission (NBAC) transmitted its report, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, to President Bush. The report issues a series of recommendations to reduce the potential for the exploitation of research participants in developing countries. On April 30, NBAC issued recommendations from the report to the public aimed at improving the conduct of international clinical trials. The recommendations focus on reducing the exploitation of research participants in developing countries; addressing the research study in the context of the developing nation's health needs; and improving post-trial access to successful research products. NBAC issued the report in light of the growing number of U.S. collaborations with scientists from developing countries. The FDA's acceptance of clinical trial data is a major recommendation of the report. The report states that "The Food and Drug Administration should not accept data obtained from clinical trials that do not provide the substantive ethical protections outlined..." The ethical protections outlined in the report mirror those provided to human subjects in the U.S. under our regulatory framework.
Institute of Medicine
The IOM has issued the first of two reports required under a contract with the Department of Health and Human Services (DHHS). The IOM has formed the Committee on Assessing the System for Protecting Human Research Subjects to examine how to improve the structure and function of the review and protection of human subjects in clinical research programs. In its report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, the IOM recommends that the standards proposed by the National Committee for Quality Assurance (NCQA), a contractor of the U.S. Department of Veteran's Affairs, appear to be the most promising for use in research institutions. This determination is a result of a specific review of existing and proposed standards from several entities. The IOM believes that the NCQA standards provide the strongest basis for pilot testing in research institutions since they address aspects of quality improvement, provide flexibility in achieving performance goals, and are based on current regulations. The report also recommends that these baseline standards be strengthened in the following manner: determining how researchers, not just the protocols, will be reviewed; how sponsors will be assessed; how research participants should be involved in setting standards; and establishing oversight mechanisms to ensure the safety of research participants.
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