Does the FDA’s Willingness to Green Light Medications Sidestep Safety Issues?

FDA Approvals and Dangerous Drugs

Is the U.S. Food and Drug Administration (FDA) approving too many dangerous drugs? According to a recent article in the Boston Globe, new medications that get FDA approval for safety and efficacy “have more than a one in four likelihood of getting a black box warning or being withdrawn from the market within 25 years of their approval.” In other words, about 25 percent of all drugs approved by the FDA are later deemed unsafe for use.

The number of hazardous medical products on the market has risen over the last two decades. Back in 1992, when Congress passed the Prescription Drug User Fee Act, about 1 in 5 (or 20 percent) of all drugs approved would later be deemed unsafe for use at a date in the future. The Prescription Act led to more approvals because it permitted the FDA to “collect industry fees to speed drug approvals.”

How do we know about the recent FDA approval statistics? Researchers at the Tufts Center for Drug Development, took a close look at nearly 750 different medications that have been approved between 1975 and 2009, all of which ended up withdrawn from the market or received a black box on their label. The black box is the FDA’s harshest way to warn doctors and patients about potentially dangerous side effects.

The researchers at Tufts could not conclude with certainty that the FDA has approved more dangerous drugs in recent years. Yet, the fact that 25 percent of approved drugs are withdrawn or given a black box label – is an important reminder to consumers to be aware of potentially harmful side effects of dangerous drugs.

FDA Approval Facts and Statistics

The drug development and approval process is a long one, typically taking between 8 and 19 years on average, according to statistics reported by the FDA. These numbers do not include the marketing phase of drug development, during which “postmarket surveillance” typically takes 11 to 14 years on average.

How exactly does the FDA approval process work? The following four stages of development and approval exist:

  • Preclinical: This phase takes approximately 1 to 6 years. During this time, the manufacturer usually conducts limited animal tests and purifies the drug. Afterward, drug companies and other manufacturers can submit an Investigational New Drug Application (IND).
  • Clinical: If the IND gets approved, three different phases of clinical trials using healthy individuals must be conducted. The clinical stage takes approximately 6 to 11 years.
  • Approval: Only after three phases of clinical trials can a manufacturer seek FDA approval with a New Drug Application (NDA). Review of the NDA usually lasts 1 to 2 years. During this period, the FDA consults expert advisory committees about drug safety, labeling, and drug effectiveness.
  • Market: Postmarket surveillance typically lasts from 11 to 14 years, and it involves the FDA recording adverse events, requesting labeling changes to products, and in some cases withdrawing the drug from the market.

Despite the thorough approval process, there are many new medications approved each year which may cause serious and sometimes fatal side effects. Therefore, research the side effects of any new medication before use.

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