Thousands of prescription drug products sold in the U.S. not approved by FDA

Sep 20 2006

Drugs that have not been approved by FDA make up nearly 2% of prescription drugs on the market, and some of them "might not only be ineffective but also might actually be harmful," USA Today reports.

The drugs have "official-sounding names," are advertised in medical journals and are available by prescription, and they often are mistaken for FDA-approved drugs, according to USA Today. The agency estimates that 2,000 or more prescription products are on the market that contain several hundred ingredients that have never been approved, including antihistamines, narcotics and sedatives. USA Today reports that many of these ingredients have been in use since before 1962, when an amendment to the Food, Drug, and Cosmetic Act required that treatments be proven effective, rather than just safe, which was the previous requirement. The drugs -- marketed for a range of ailments including colds, coughs, ear infections, hot flashes and pain -- have been linked to dozens of deaths, according to FDA. The agency says that for now, it plans to target only the most dangerous drugs because market removal of prescription products is a "resource-intensive process," according to Deborah Autor, FDA's director of compliance. In the meantime, FDA advises doctors, pharmacists and consumers who are often "ignorant of the drug's status" to be aware of the issue, USA Today reports. According to a URL/Mutual Pharmaceuticals-commissioned national survey of 500 pharmacists, 91% thought all the products they dispense are FDA approved.

Comments Autor said, "We have concerns about [unapproved prescription drugs'] safety, about their quality, about their labeling. Just because people think something works doesn't necessarily mean that it does." Manufacturers of the unapproved drugs say that the medicines would not be prescribed by doctors if they were unsafe or ineffective. Paul Bagley, CEO of drug company Pharmics -- which sells unapproved products -- said, "'Unapproved' sounds horrible. A lot of these products have been on the market for 50 years. They've been time-tested better than a lot of the new products approved by FDA." Manufacturers add that the regulatory process would cost them millions of dollars, which would have to be passed to the consumer. David Carsky, managing director of Virginia-based drug maker ECR Pharmaceuticals -- which also markets drugs that have not been approved by FDA -- said, "All of us are in business to make a living. The endpoint is we want to supply quality drugs for a reasonable price." However, Kenneth Kaitlin, head of the Tufts Center for the Study of Drug Development, said, "I want a product the FDA has authorized. The FDA is not infallible, but it's the best thing we've got for ensuring the quality of our drug supply" (Rubin [1], USA Today, 9/18).

Example USA Today on Monday profiled Solvay Pharmaceuticals' combination estrogen-testosterone drug Estratest, which has been in use for more than 40 years and has never been approved by FDA (Rubin [2], USA Today, 9/18).