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NCJ Number: 128162 Find in a Library
Title: New Rules for New Drugs: The Challenge of AIDS to the Regulatory Process
Journal: Milbank Quarterly  Volume:68  Issue:1  Dated:(1990)  Pages:111-142
Author(s): H Edgar; D J Rothman
Date Published: 1990
Page Count: 32
Sponsoring Agency: American Foundation for AIDS Research
New York, NY 10022
Type: Legislation/Policy Analysis
Format: Article
Language: English
Country: United States of America
Annotation: AIDS is systematically changing attitudes and practices toward the regulation and use of drugs, and research protocols developed by the Food and Drug Administration (FDA) prior to the 1980's to minimize risk to subjects are shifting to maximize innovation.
Abstract: The FDA has adopted new procedures to speed access to investigational drugs and ease drug importation for personal use. These procedures, in effect, transfer decisions about drug risks and benefits from the agency's staff to patients and their physicians. The greatest concession to consumer entitlement is the recently announced FDA policy of permitting drug importation for personal use. This policy represents a striking departure from the FDA's prior insistence on its legal duty to enforce prohibitions on introducing unproven drugs into U.S. commerce. Over time, however, easy toleration of imports may adversely affect other aspects of the U.S. pharmaceutical industry. One consequence of the FDA's change in policy is that third-party payers will be increasingly reluctant to pay for expensive treatments simply because the FDA has allowed them on the market. New therapies will often be very expensive, especially those produced by genetic engineering. Pressure at the Federal level to speed up the distribution of investigational drugs is intense. Parallel tracking is intended to make drugs available that have been demonstrated safe but have not completed full testing. While the FDA's tilt toward embracing consumer rights may continue in the near future, disappointing results may prompt the agency to reassert its authority in controlling drug policies more restrictively. 30 references
Main Term(s): AIDS/HIV prevention; Drug regulation
Index Term(s): Attitudes toward AIDS; Food and Drug Administration (FDA)
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