107th Congress

Access to Medical Treatment Act of 2001

H.R. 1964, S. 1378, and S. 2207

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. These measures would have allowed patients to receive, and health practitioners to provide, under certain conditions, drugs and medical devices that had not been approved by the Food and Drug Administration (FDA). H.R. 1964 and S. 1378 included reporting requirements for practitioners if they discovered that unapproved drugs or medical devices posed a danger to patients.

Both bills contained a provision that would have required 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 have been required to analyze and make these 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."

On April 18, 2002, Senator Daschle introduced S. 2207, the Access to Medical Treatment Act, a clean version of S. 1378. This measure contained the same provisions and goals of S. 1378, in less detail.

Provisions of the Legislation/Impact on NIH

The legislation defined requirements that health practitioners would have had to fulfill in order to prescribe unapproved drugs and medical devices. If a practitioner discovered that an unapproved product posed a danger to a patient, the practitioner would have been required to immediately cease use of the product and report the adverse event to the product's manufacturer and the Director of the Centers for Disease Control and Prevention (CDC). Immediately upon receipt of such a report, manufacturers would have had to cease the sale and distribution of the questionable drugs and devices. The legislation would also have required the Director of CDC to investigate such events and provide a report to the Secretary of Health and Human Services (HHS). The Secretary of HHS would also have been 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 included a provision detailing the procedures for reporting positive results related to unapproved drugs and medical devices. The bills would have required health care practitioners who prescribed or administered products that had not received FDA approval to report to the manufacturers any results that were more beneficial than results that would have been attained through the use of FDA-approved products already on the market. Manufacturers who received such reports would have had to transmit this information to the Director of NCCAM.

Section 5 of S. 2207 would have required the practitioner to make a report directly to NCCAM instead of to the manufacturer of the unapproved drug or device.

The Director of NCCAM would have been required to review and analyze reports from manufacturers and make such reports public via the Internet. The Director of NCCAM would also have been required to compile 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 Energy and Commerce Committee; the measure was referred to the House Energy and Commerce Subcommittee on Health on June 8. H.R. 1964 had 14 cosponsors.

S. 1378 was referred to the Senate Health, Education, Labor and Pensions Committee on August 3, 2001. The measure had five cosponsors.

S. 2207 was referred to the Senate Health, Education, Labor and Pensions Committee on April 18, 2002. The measure had two cosponsors.

No further action was taken on this legislation during the 107th Congress.