108th Congress

Access to Medical Treatment Act

H.R. 2085, S. 1410

Background

On May 14, 2003, Representative Peter A. DeFazio (D-OR) introduced H.R. 2085, the Access to Medical Treatment Act. Senator Tom Harkin (D-IA) introduced S. 1410, an identical measure, on July 15. These measures would have allowed patients to receive and health practitioners to provide drugs and medical devices not approved by the Food and Drug Administration. H.R. 2085 and S. 1410 included reporting requirements for practitioners if they discovered that unapproved drugs or medical devices pose a danger to patients. Representative DeFazio and Senator Thomas A. Daschle (D-SD) previously introduced identical versions of these measures during the 107th Congress.

Provisions of the Legislation/Impact on NIH

Both H.R. 2085 and S. 1410 contained provisions 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, who would have been required to analyze these findings and make them public via the Internet.

The measures would have also defined requirements that health practitioners would have been required to fulfill in order to prescribe unapproved drugs and medical devices. If a practitioner discovered that an unapproved product poses a danger to a patient, the legislation would have required the practitioner to 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.

Status and Outlook

H.R. 2085 was introduced by Representative DeFazio on May 14, 2003, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 108th Congress.

S. 1410 was introduced by Senator Harkin on July 15, 2003, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action occurred on this legislation during the 108th Congress.