Access to Medical Treatment Act of 2001
H.R. 1964 and S. 1378

107th Congress

Background

On May 23, 2001, Representative Peter A. DeFazio (D-OR) introduced H.R. 1964, the Access to Medical Treatment Act of 2001. Senator Thomas A. Daschle (D-SD) introduced S. 1378, an identical measure, on August 3, 2001. Under certain conditions, these measures would allow patients to receive, and health practitioners to provide, drugs and medical devices that have not received approval by the Food and Drug Administration (FDA). H.R. 1964 and S. 1378 include reporting requirements that practitioners must adhere to if they discover that unapproved drugs or medical devices pose a danger to patients.

Both bills contain a provision that would require manufacturers of unapproved drugs or medical devices to report beneficial results of these products to the Director of the National Center for Complementary and Alternative Medicine (NCCAM), who would be required to analyze and make such findings public via the Internet. Upon introduction of S. 1378, Senator Daschle stated, "This legislation will help build a knowledge base regarding alternative medicine treatments by requiring practitioners to report on effectiveness. This is critical because current information available about the effectiveness of many promising treatments is inadequate. The information generated through this Act will begin to reverse this information gap, as data are collected and analyzed by the [National] Center for Complementary and Alternative Medicine at the National Institutes of Health."

Provisions of the Legislation/Impact on NIH

The legislation defines requirements that health practitioners would have to fulfill in order to prescribe unapproved drugs and medical devices. If a practitioner discovers that an unapproved product poses a danger to a patient, the practitioner would be required to immediately cease use of the product and report the adverse event to the product's manufacturer and to the Director of the Centers for Disease Control and Prevention (CDC). Immediately upon receipt of such a report, manufacturers would have to cease sale and distribution of the questionable drugs and devices. The legislation would also require the Director of CDC to investigate such events and to provide a report to the Secretary of Health and Human Services (HHS). In addition, the Secretary of HHS would be required to disseminate information about dangerous products to all health care practitioners, the Director of NCCAM, and State regulatory agencies.

Section 5 of both measures includes a provision detailing the procedures for reporting positive results related to unapproved drugs and medical devices. The bills would require health care practitioners who prescribe or administer products that have not received FDA approval to report to manufacturers any results that are more beneficial than results that would have been attained through the use of FDA-approved products that are already on the market. Manufacturers who receive such reports would have to transmit this information to the Director of NCCAM.

H.R. 1964 and S. 1378 would require the Director of NCCAM to review and analyze reports from manufacturers and make such reports public via the Internet. In addition, NCCAM would be required to compose an annual review and analysis of beneficial reports received from manufacturers.

Status and Outlook

On May 23, 2001, H.R. 1964 was referred to the House Committee on Energy and Commerce; the measure was subsequently referred to the Subcommittee on Health on June 8, 2001. H.R. 1964 currently has 14 cosponsors.

S. 1378 was referred to the Senate Committee on Health, Education, Labor and Pensions on August 3, 2001. The measure currently has five cosponsors. No further action has occurred.