FDA should loosen efficacy standards for "harmless" products, lawyer tells Hill hearing.
This article was originally published in The Tan Sheet
Executive Summary
FDA EFFICACY STANDARDS FOR "HARMLESS" PRODUCTS should be loosened, Houston-based lawyer Richard Jaffe suggested at a July 25 House Commerce/oversight subcommittee hearing on allegations of FDA retaliation. "The law, regulations, and their implementation must include a harm or risk analysis as a factor in drug approval," Jaffe declared. "Of course, this may result in some harmless but ineffective products coming on to the market," Jaffe declared. However, he maintained that "more often than not the marketplace itself can separate the wheat from the chaff."