FDA Drug Recall

An FDA drug recall is based on medical research and clinical trials. FDA recalls are frequently in the news. In order for a drug medication to be approved, the FDA must find it both safe and effective. Sometimes a drug is not dangerous, it is just ineffective.

An arm of the FDA called the Center for Drug Evaluation and Research (CDER) reviews the reports of a drug’s studies so that the Center can evaluate the data. Hospitals and clinics around the country and the world conduct these studies. The pharmaceutical companies pay for these studies.

Congress in 1992 passed the Prescription Drug User Fee Act (PDUFA). This law allows corporations to provide CDER researchers with money to speed up the FDA approval process. In four years the FDA was approving drug medications at twice the rate. They received over $300 million annually for pharmaceutical companies. (2007 FDA)

Some people think that this accelerated approval process has led to more FDA recalls. This cannot be proven. Since 1980, the approximate time between FDA approval and FDA recall for drug medications is just over five years.

An extreme case of recall occurred with the drug phenylpropanolamine (PPA). It remained a stroke suspect for twenty years before a Yale University study confirmed the link between PPA and hemorrhagic strokes. The FDA recalled the drug in 2000. Estimates are that PPA caused 200 – 500 strokes in people less than 50 years of age every year.

The FDA openly acknowledges that not all effects of a drug medication are documented or even known at the time of approval. This is because safety standards for the drug are performed on small groups of patients.

Exactly what is an FDA drug recall? Very rarely does the FDA, working under the statutes of the Federal Food, Drug, and Cosmetic Act of 1938, confiscate a product or “order” a recall. Instead, the FDA usually requests a company to recall its product. Companies comply because of bad publicity or the threat of lawsuits. Because of the bad publicity for the FDA that certified the recalled drug as safe, sometimes the FDA will work with pharmaceutical companies and doctors to alter the warning labels until the point when the drug medication proves too dangerous to keep selling.

The product recalls by a pharmaceutical company fall into three categories.

• Class I recall – There is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
• Class II recall – The use or exposure to the product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
• Class III recall – The use or exposure to the product is not likely to cause adverse health consequences.

The most recent FDA recall news item involves the diet drug, Meridia. There are studies linking the drug to cardiovascular problems including heart attacks and strokes. The FDA panel was split. Eight members called for withdrawal; six members called for restricted sales and a “black box” warning; two members called for the warning plus close monitoring of patients. The FDA’s own monitoring linked 14 deaths to the use of Meridia.

The FDA first approved Meridia in 1997, and it increases the risk of heart attack and stroke by 11 percent, while doing little to assist with weight loss. In a study on Meridia published in the New England Journal of Medicine in September 2010, the risk of a stroke, heart attack, cardiac arrest or cardiac death was 16 percent higher among patients taking Meridia, compared to those taking a placebo. All of the 9,804 overweight or obese participants had a history of cardiovascular disease.

Abbott Laboratories maintains that “the risks of Meridia are outweighed by its benefits and that new data on its cardiovascular safety doesn’t change the fact that it is safe for patients when used strictly according to its label.”

This is just one of the controversies surrounding very popular drugs. The fast pace of drug recalls is continuing in 2010. FDA drug recalls totaled 296 from January through June. At that rate there could be 600 for the year. That is a high rate of recall.

The problems over recalls have drawn the attention of lawmakers. Two bills introduced in 2010 would impose stricter regulations on the industry and give the FDA authority to mandate recalls. Stay tuned to this web site for updates to the FDA drug recall regulations.

Written by: Margaret Stenerson

9 29 2010