More about FDA Drug Recalls

Recalls issued by Food and Drug Administration (FDA) officials are, fortunately and unfortunately, rare:

Fortunately, a FDA drug recall means that one fewer dangerous medication causing patients unnecessary harm and death is on the market.Unfortunately, there is no reason to believe the rarity of recalls suggests drugs on the market are safe enough to belong there. The average time on market for a recalled drug is five years. Many people are injured during this time by drugs that should be recalled.

Worse, fewer FDA drug recalls could be a warning sign that our federal protective agency is subject to pharmaceutical industry pressure to keep dangerous drugs with inadequate testing on the market.

More U.S. citizens die from the effects of prescription drug medications than illegal drugs. It is important to understand more about the agency that approves, regulates, and recalls drug medications on the market.

FDA and Drug Medication Applications and Approvals

Once there was a time when FDA scientists would test potentially hazard drug medications and devices on themselves. Now drug medication approval comes from FDA reviewing a pharmaceutical companies’ clinical trials (human testing), a process that has been sped up with 1992’s fast-tracking program. This program allows pharmaceutical corporations to give FDA money to approve their drug medications more quickly.

While the 1992 Prescription Drug User Fee Act (PDUFA) reduces the time it takes to get important drugs on the market, it compounds conflict of interest concerns already present in FDA approvals and recalls. (1)

FDA Classification and Terms

FDA, as part of the Department of Health and Human Services, is granted the power to make important labeling changes that may impact the health of consumers, announce safety alerts, and request companies recall their unsafe products from market.

Most often when drug medication problems are reported, FDA works with the pharmaceutical company to adjust the labeling on drug medication and to release statements to the public. These warnings can come in the form of a:

  • FDA Dear Healthcare Professional letter (aka “Dear Doctor” letter) sent to U.S. doctors to update them about important prescription problems or labeling with a drug medication. This, rather than a recall, shifts the safety burden to doctors.
  • black box warning, the most serious warning FDA officials issue outside of a complete ban on a product. Antidepressants causing suicidal tendencies and the acne medication Accutane that causes birth defects both carry this FDA drug medication labeling but were not recalled.
  • safety alert , FDA’s public warning about a product that may present an unreasonable risk of substantial harm or has not been approved by FDA regulators. Often safety alerts take the form of advice, such as the frequently updated warnings against buying drug medications online.

The most serious form of FDA safety alert is the recall.

FDA Drug Recalls Explained

FDA officials do not “order” recalls. If a company does not recall their own product at FDA officials’ request, FDA can take the company to court and ask for legal action (an “injunction”). After the drug medication is recalled by the company, FDA officials check up on the pharmaceutical company and read its reports on the status of the product.

When FDA announces a recall, it usually assigns the drug medication a class:

  • Class I recall is reserved for dangerous drug medications that could cause serious health problems or death. A good example of this was the “natural” male potency pills pulled from market in February 2007 for containing unlabeled sildenafil (the active ingredient in Viagra that may cause heart problems).
  • Class II recall is for drug medications causing temporary (nonlethal, nonpermanent) injury. An example is a shipment of drug medication manufactured under-strength or labeling printed with incorrect dosage strength.
  • Class III recall is for drug medications that might not have harmful effects but violate FDA labeling or quality regulations. An example would be when crystals develop in an ointment or when gel tablets do not dissolve properly.

Similar to a recall, FDA might also remove a product from market with a withdrawal. A withdrawal implies a company’s product has a minor violation that is not the fault of the company but still remains a danger. An example of this withdrawal occurred in the 1980s when Tylenol removed its old products from stores to replace them with tamper-proof containers.

Bad Corporate Science Prolongs FDA Drug Recalls

Pharmaceutical companies have learned lessons from tobacco special interest groups fighting legislation: be creative in the scientific process. Because FDA regulators do not conduct original drug medication safety research, they are reliant upon corporations’ results—or what they say their results are. (Click to read more about how corporate scientists pervert science in Doubt is Their Product.)

Pharmaceutical giant Merck’s doctors came up with some interesting conclusions at the end of their twelve-month 1999 study of Vioxx’s effect on stomach tissues. As pharmaceutical company doctors had hoped, they found that Vioxx was better on a patient’s stomach than the similar drug medication naproxen (Aleve). But Merck doctors also found that patients taking Vioxx had five times the chance of acute myocardial infarction (heart attack) than patients taking naproxen—or, as they reported in a perversion of science:

“Overall, the risk of the combined endpoint of cardiovascular or unknown death, myocardial infarction, and cerebrovascular accident was reduced by 47% in the naproxen group relative to the rofecoxib group in the VIGOR study.”

In other words, instead of saying their dangerous drug increased the risk of heart attacks by 400%, pharmaceutical scientists reported the control/base medication reduced the chance of heart attack by80%. This is similar to a tobacco company saying that chewing gum adds ten years to your life (instead of reporting that smoking takes ten years off).

These white lies and science fictions have serious real world consequences. FDA estimates that Vioxx caused 88,000 – 139,000 heart attacks, about one-third fatal, in the 5 years before its recall.

Dangers of Legal Drug Medications

FDA announces recalls only after it discovers a problem. This reactive approach means that the final test of safety is the public. With increased consolidation and corporatization since the 1980s, the pharmaceutical industry is driven to frequently release new drugs onto the market to satisfy investors—a drive that can place pills and profits against the public good.

If you have been injured by a dangerous medication, contact the Consumer Justice Group to learn what legal action can be taken to help get your life back together. We have lawyers working around the country experienced in making pharmaceutical companies pay.

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