A Long Reach Back to Assure Drug Quality

By Hecht, Annabel | FDA Consumer, December 1984 | Go to article overview

A Long Reach Back to Assure Drug Quality


Hecht, Annabel, FDA Consumer


Say "DESI" to most consumers and you'll likely be greeted with blank stares. What they don't realize is that these four letters have had a major impact on the quality of the medicines they take. The acronym stands for Drug Efficacy Study Implementation, an FDA program considered the most far-reaching evaluation of the effectiveness of prescription drugs in the history of drug regulation worldwide.

Virtually finished in September 1984, the multi-million-dollar project involved the review of more than 3,400 prescription drugs with more than 16,000 therapeutic claims. The end result:

* 1,099 drugs were found to be inefective and were taken off the market.

* 2,302 were found effective, with any questionable claims removed from the label.

* About 7,000 drugs identical or similar to the drugs under review were relabeled or withdrawn from the market.

The DESI project was mandated by the 1962 Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act, which required manufacturers to prove that their products were effective--that is, that the drugs did what they were supposed to do. (Proof of safety had been required since 1938.) The new amendments were to be applied to all new drugs and, retrospectively, to those approved by FDA in the years between 1938 and 1962.

Such a retrospective review was a huge order, not only because of the sheer numbers--a total of 3,443 prescription and 532 nonprescription drug products--but also because most of these drugs had several intended uses. In fact, on the average, the manufacturers claimed their products could be used for as many as five conditions. Each claim had to be evaluated. In addition, for every drug initially sold between 1938 and 1962 with FDA approval, five others were on the market without approval. Many were copies of or closely related to previously approved drugs. Others were combinations of approved ingredients. Altogether, the study covered 80 percent of the prescription drugs sold in the United States.

Because of limited resources, FDA asked the National Academy of Sciences/National Research Council (NAS/NRC) to conduct the first phase of the review. The study was conducted by 30 panels, each composed of six medical experts. Each panel was assigned to a different category of drugs--antibiotics, heart drugs and so forth.

The NAS/NRC panels evaluated evidence of effectiveness from material submitted by the manufacturers, information in FDA's files, and a review of medical literature. Each claimed use for each drug was rated as:

* Effective--The evidence was adequate to justify the claim. …

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