72 million U.S. prescriptions per year are not FDA-Approved

An Associated Press analysis last week concluded that millions of Americans are being prescribed drugs — including those covered under Medicaid — that have never been reviewed by the FDA for safety and effectiveness. The FDA admits there may be thousands of such drugs on the market. Reports the AP:

“At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system … But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year.”

This isn’t a new problem — most of the drugs in question have been on the market for five decades or more — but it’s a story that gets more galling over time. The history is, it was only in 1962 that the FDA began reviewing new medications for safety. Medications already on the market at that time were to be vetted by the FDA eventually … but 46 years later, thousands of meds have never been reviewed at all.

According to the AP:

It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn’t. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed a possible starting point for a list.

Among the drugs the AP’s research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR…

Federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

This is another instance where it’s in your interest to do your own research on the drugs you are prescribed. Many doctors and pharmacists are unaware that drugs they are prescribing and dispensing have never been vetted by the government — but you can find out for yourself with a little Internet searching.

Drugs@FDA is an FDA Web site that allows you to search government-approval information on “most of the drug products approved since 1939.” Additionally, the site includes “the majority of labels, approval letters, reviews, and other information available for drug products approved from 1998 to the present.”

The FDA offers other resources for determining if a drug is approved here.

For FDA updates and AP news on 200 of the most commonly prescribed drugs, you can also check out eDrugSearch.com’s Online Pharmacy Dictionary.

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