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

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 journalNature 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.

Center for Drug Evaluation and Research (CDER) faces concerted pressure from pharmaceutical companies to get their drug medications FDA approval. Pharmaceutical companies want to recover the costs of research, advertising, and sales representatives’ salaries, as well as raise the value of the company stock. Sometimes the public good gets in the way of profits.

Consumer Safety and FDA Drug Medication Recall

Since 1980, the approximate time between FDA approval and FDA recall for recalled drug medications is just over five years–if extreme cases such as phenylpropanolamine (PPA) are omitted. PPA, which remained a stroke suspect for 20 years before a Yale University study confirmed the link between PPA and hemorrhagic strokes, was subject to FDA recall in 2000. FDA estimates PPA to have caused 200-500 strokes in people under 50 years old every year.

The increased approval speed after the passing of the 1992 Prescription Drug User Fee Act (PDUFA) has also led to an increase of recalls in the past decade. While pharmaceutical corporations praise FDA for approving their products quickly, a subtle shift seems to have occurred in FDA conception of a safe drug medication and the role of recall—especially when this “fast-tracking” pays a large portion of CDER’s salaries. Read more about pharmaceutical firms funding FDA in this article from The New England Journal of Medicine.

FDA openly acknowledges in its recent statements that not all effects of a drug medication are documented or even known at the time of approval. This is because the safety standards for drug medications are tested by the pharmaceutical corporations on small groups of patients. FDA approvals, in many ways, are not seen by the agency as proof of safeness but as another step in testing drug safety. The general public is used as guinea pigs as labeling changes are made and the drug medication left as long as possible on the market before being recalled.

FDA Recalls, Friendly Requests among Bedfellows

There is some general confusion about what a FDA recall is. Very rarely does FDA, working under the statutes of Federal Food, Drug, and Cosmetic Act (1938), confiscate a product or “order” a recall. Instead, FDA usually requests a company recall its product, and companies comply under the threat of bad publicity and lawsuits. Once FDA recalls and the company decides to remove its product, the company is supposed to keep FDA updated about the status of drug medications remaining on the market.

Because of the bad publicity it brings to the agency that certified the recalled drug medication as safe, FDA often refrains from issuing a “safety-based” drug recall. Instead, it prefers to work with pharmaceutical companies and doctors to alter warning labels until the drug medication proves too dangerous to keep selling.

Interested in learning more about FDA drug medication recalls?

Faster FDA Approval, Slower FDA Recall

Pharmaceutical companies and their paid political proponents often complain about how long and expensive gaining FDA approval is. FDA has the stated goal of approving drug medications within six months for priority review (for drug medications that offer major medical advances) or ten months for standard review (for drug medications that offer only minor improvement on existing medication), designations it established in 1992.

The number of new drug medications approved each year by FDA began doubled during the 1990s and has only recently returned pre-PDUFA levels.

During this spike from 1992 to 2001, ten drug medications were subject to FDA recall because of unacceptable adverse reactions discovered after regulatory approval, an average of one FDA-approved drug medications recalled every year.

Though there are signs FDA might be cleaning up its act, it is too early to tell. Even if the agency could go another three years as it once did in the 1980s without a safety-based drug recall, this is no assurance that the drug medications given FDA approval during this time are safe. Since 1980, the average time between approval and recall is five years. The slower and more cautious our regulatory agency is, the more pressure it receives from pharmaceutical companies.

Big Profits before FDA Recall

After a big boom in pharmaceutical start-ups in the 1970s, buyouts over the past three decades have led to the consolidation of numerous pharmaceutical companies. With direct-to-consumer advertisement of the late 1990s, a practice banned in almost all European countries, large pharmaceutical corporations continue to grow.

These pharmaceutical companies jointly form a profitable and powerful industry in the U.S. and employ hundreds of lobbyists to promote their causes. These corporations make a tremendous return on their investments. The top ten U.S. pharmaceutical companies by sales each spend less than 20% (some less than 10%) on research and development. Manufacturing only accounts for another 20-25%. The rest goes to advertisements, salaries, and sales.

Top pharmaceutical companies’ CEOs are well paid, many ranking in the Top 50 highest paid persons in America. The top ten pharmaceutical CEOs make $4-$31 billion a year with $10-$200 billion in stock options.

Additionally, there are over 100,000 pharmaceutical sales reps in the United States with midrange pharmaceutical companies averaging 100 to 1,000 representatives pushing their product onto doctors. There were twice as many sales reps employed in 2003 than in 1999, costing U.S. companies $5 billion a year influencing doctors with gifts, free lunches, and other paid functions. Read more about pharmaceutical sales reps’ influence.

FDA Recalls, Pharmaceutical Money, and Public Health

FDA recalls are not enough.

Just this year (March 2007), Zelnorm, a popular drug for irritable bowel syndrome and constipation, was subject to a FDA recall after Swiss scientists showed that higher chance of cardiovascular events, such as heart attack, stroke, or severe heart–related chest pain in patients treated with Zelnorm compared with those given a placebo. Approved in 2002, it has taken five years for the FDA to recall a drug which should never have had approval.

If you or someone you know has been had been hurt by Zelnorm or another drug, act now. Contact the Consumer Justice Group to make pharmaceutical companies pay for the damage unsafe drug medicines cause.