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In February 1973 FDA finalized plans to conduct a systematic efficacy review of all licensed biological products, modeled on its review of over-the-counter drug products that had been launched the previous year. Commissioner Charles Edwards appointed six advisory panels of experts that would review the evidence and assign each biological product to one of the following categories: safe and effective; unsafe and/or ineffective; requiring further study but to remain available in the interim; and lacking sufficient data to be determined safe and effective and recommended for market removal. Much as the case with new drugs, the proof of effectiveness would be expected to derive from adequate and well-controlled investigations. And much like the case with drugs, the review lasted decades. Along the way, though, some licenses have been revoked, such as in 1977 when FDA announced its intention to revoke the licenses of eight skin tests for tuberculosis, diphtheria, and other diseases and conditions.

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The retrospective biologics review also included an evaluation of product labeling, and in one quarter of 1973 alone the Bureau received nearly 500 submissions of proposed labeling from manufacturers of both licensed commodities and products awaiting licensure.  Advertising, too, was part of the Bureau’s oversight, that function first assigned to FDA for prescription products under the 1962 Drug Amendments.  For example, in 1973 Bureau monitoring of professional journal advertising resulted in a notice to one manufacturer for corrective changes to claims made.

The biologics review panels had completed their reviews or issued their final reports in 1980.  For example, the Panel on Review of Bacterial Vaccines and Bacterial Antigens (with no U. S. Standards of Potency) deemed none of the products they reviewed safe and effective.  On the other hand, the Panel on Review of Blood and Blood Derivatives determined that most blood bank and plasma fractionation products were safe and effective.  Implementing their recommendations, as FDA learned through its retrospective reviews of prescription drugs, would take longer.  However, as mentioned previously, a number of tests that the Panel on Review of Skin Test Antigens deemed either unsafe or ineffective, misbranded, or inconclusive with potential risks outweighing benefits were removed from the market.

Center for Biologics Evaluation and Research

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