FDA Recalls: America’s (Legal) Drug Medication Problem

FDA approves dangerous drug medications. Doctors unknowing prescribe these expensive drug medications. Patients die. FDA recalls dangerous drug medications. The manufacturer of the recalled drug medications makes astronomical profits—enough to settle lawsuits for permanent injury and death their drug medications caused before recall, enough to again set record profits for the quarter.

That’s been the story for over a decade.

Every drug medication available in the U.S. is a result of a cost-benefit analysis of its therapeutic value versus its adverse (harmful) effects, a determination made by Food and Drug Administration (FDA) scientists. Unfortunately, the process by which FDA approves and recalls drug medications as well as the influence pharmaceutical companies exert on the process is not understood by the public.

This Consumer Justice Group newsletter helps explain the deficiencies in FDA drug approval process and why FDA drug medication recalls have increased in recent years.

FDA Drug Medication Approval and Recall

Since its beginnings in a 1902 law, FDA has been the agency in charge of regulating our food and drugs, including nutritional and dietary supplements, over-the-counter and prescription drug medications, vaccines, cosmetics, and medical devices such as pacemakers, contact lenses, and hearing aids.

In order for a drug medication to be approved, FDA must find it both safe and effective. An ineffective drug medication can also be recalled from the market. Recently (April 2007), FDA recalled suppositories containing trimethobenzamide hydrochloride for this reason. While not dangerous, these drug medications did not effectively treat nausea as advertised.

Despite popular misconception, “FDA does not develop, manufacture, or test drugs,” as stated on FDA’s website. Instead, Center for Drug Evaluation and Research (CDER), the drug approval and recall branch of FDA, reviews “reports of a drug’s studies [from pharmaceutical companies] so that the Center can evaluate its data.”

Corporate Influence on FDA Drug Medication Approval

More startling than FDA’s not conducting its own drug medication research and more disturbing than pharmaceutical companies not being required to make their research results public is the power pharmaceutical company money has over the drug medication approval process.

Bowing to these companies’ special interest pressure, Congress in 1992 passed the Prescription Drug User Fee Act (PDUFA). This act allows corporations to provide CDER researchers money to speed up the FDA approval process. Within four years, FDA was approving drug medications at twice its pre-PDUFA rate and receiving over $300 million annually from pharmaceutical companies, according to a March 23, 2007 FDA press release. (The consequences of this FDA rate increase will be visited on Page 2 of this FDA Recalls Newsletter.)

FDA researchers are not immune to the influence of money. In 2005, renowned science journal Nature reported that over half of FDA panels writing drug usage guidelines had at least one member with financial ties to the company whose product was being reviewed - click here to read. The next year (2006), FDA Commissioner Lester Crawford left his position and plead guilty to having illegal ties to pharmaceutical companies. He was sentenced for these conflict of interest. Click on one of the following to read: 1) Crawford’s guilty plea and sentencing, 2) a newspaper account of Crawford’s resignation from FDA, or 3) Crawford’s 2004 FDA statement on conflict of interests and FDA ethical standards.

In response to public reaction, FDA announced in March 2007 that it will put forth new guidelines for keeping people with these conflict of interests off advisory panels.

Unfortunately, as we see in the case of recent FDA recalls, the damage might have already been done.

The Pharmaceutical & Drug Recall News is a service of the Consumer Justice Group.