FDA reform efforts attempt to balance speed, safety

Article Abstract:

The US Senate Labor and Human Resources Subcommittee is drafting legislation to streamline the Food & Drug Administration (FDA) and speed up the process of approving new drugs and medical appliances. The House Commerce Committee plans to propose legislation approving user fees that pharmaceutical companies pay to speed up trials of new drugs. The AMA and at least 100 consumer groups are lobbying to make sure the new law furthers their interests.

Product development, Health care industry

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Congress urged to keep FDA strong; AMA will monitor reform

Article Abstract:

The American Medical Assn wants Congress to keep the Food and Drug Administration strong with adequate funding and regulatory power. There are complaints that the agency approves new drugs too slowly but the US has introduced fewer problem drugs than other countries. Prescription drug approval took an average of 19.7 months in 1994, a decrease of 24% from 1992. The approval rate is expected to reach the same rate as other countries in 1997.

American Medical Association

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Cancer drugs to get speedier approval from FDA

Article Abstract:

Pres Clinton has introduced a program that will speed up the Food and Drug Administration's evaluation and approval process for new cancer drugs. The new program will reduce the testing time for new cancer drugs by one to three years, and will reduce the marketing approval process by six months. The FDA has had a fast-approval program for drugs that treat life-threatening drugs since 1991.

Care and treatment, Clinton, Bill, Social policy, Cancer, Cancer treatment

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