Study Finds Dangerous Medications Often Get Past FDA Expedited Approval Process

Dangerous Drugs Approved by FDA

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Study Finds Dangerous Medications Often Get Past FDA Expedited Approval Process

Faster drug approval by the FDA has been associated with an increase in black-box warnings and drug recalls.

A new study conducted by researchers from Harvard sheds light on the practice of dangerous drugs being allowed onto the market since an act was passed that permits drug companies to pay a fee for expedited approvals. According to the research, the FDA’s fast-track system for pharmaceutical drug approvals has resulted in a higher number of drug recalls in recent years. If you or a loved one has been harmed by a serious pharmaceutical drug side effect, consult a knowledgeable drug injury lawyer today for legal help. You may have grounds to file a product liability lawsuit against the drug manufacturing company, in order to pursue financial compensation for your injuries, medical expenses, and pain and suffering.

Defective Drug Recalls, Black Box Warnings

In 1992, the Prescription Drug User Fee Act (PDUFA) was passed, allowing drug manufacturing companies to get their new pharmaceutical drugs on the market by paying a fee to expedite the regulatory review process. While the act has resulted in a decrease in the average time it takes for a new medication to be approved – from 34 months to 16 months – it may also be exposing a large number of patients to dangerous or defective medications before side effects can be identified. In an effort to further examine this risk, researchers from Harvard analyzed drug approvals by the FDA during the past 35 years, finding that a higher rate of drug recalls are being issued since the PDUFA was passed.

Side Effects of Dangerous Drugs

From 1975 to 2009, the FDA approved 748 new molecular entities that were not over-the-counter medications. Researchers involved in the study found that 114 of these products eventually received black box warnings, the strongest drug label warning the FDA can issue, and 32 were removed from the market. According to the study authors, newer medications are 35% more likely to receive a black-box warning or be removed from the market completely since the expedited approval process was implemented by the FDA. One example is Vioxx, a nonsteroidal anti-inflammatory drug (NSAID) recalled just five years after it was approved by the FDA, after being linked to more than 80,000 cases of heart disease side effects.

Patients Exposed to Dangerous Medications

“Unfortunately, danger signals are not being detected early enough to prevent millions of patients from being exposed to unsafe drugs,” the researchers wrote. “Drugs approved after the enactment of PDUFA were more likely to receive a black-box warning or be withdrawn. Why might this be the case? One theory is that PDUFA-imposed deadlines may have caused rushed approvals, resulting in an increase in safety problems that were recognized only after a drug was already in use.” According to the researchers, expedited approval of pharmaceutical drugs may result in patients being exposed for months or even years to dangerous medications before they are removed from the market or proper warnings are put in place.

An Experienced Drug Injury Lawyer Can Help

In order to protect patients from dangerous and possibly even life-threatening pharmaceutical drug side effects, the researchers suggest that consumers and medical professionals wait until a medication has been on the market for a considerable period of time before deeming it a go-to treatment. If you believe you have been adversely affected by side effects of a dangerous drug, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by defective medications, and can help put you in touch with a qualified lawyer who has experience handling product liability claims.

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