“Grandfathering” Drugs into the U.S. Marketplace
Most people don’t realize that the U.S. Food and Drug Administration, or FDA, does not test the much-vaunted drugs that finally make their way into the consumer marketplace in the United States. This, even though the FDA is the lead agency for such screenings. In the absence of testing, one wonders where all the federal-budget dollars go. Others speculate that the FDA may be a case of too many chiefs and too few Indians.
In fact, not only does the FDA do no drug testing, or even mandate company testing, but in many instances simply assumes drugs are safe via the “grandfather rule”. That is, if a new drug comes into the marketplace with a chemical profile and a purpose which largely matches another previous product, it is automatically assumed to be as safe and efficacious as its grandfather drug. Otherwise, drug companies are expected to test their own drugs, from R&D to human trials, and provide accurate and truthful reports. Given the billions of dollars involved in getting a successful drug into the consumers’ hands, these latter two requirements invite all sorts of chicanery.Read More