10 Aug 2014

More Drug Recalls and “Black Box” Warnings Since 1992 Change in Law, New Study Concludes

A new study suggests that a 1992 law designed to make the Food and Drug Administration’s drug approval process quicker and more efficient has in fact led to an increase in the number of drugs on the market that have subsequently been recalled or had the most serious and detailed warnings applied to them.

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992. The act allowed the FDA to collect fees from pharmaceutical companies to pay for resources needed to accelerate the drug-approval process. Since its enactment, PDUFA has been renewed four times.

Published in the August issue of Health Affairs magazine, the study compared the records of drugs approved before and after the passage of PDUFA and found “that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage.” A “black box” warning is the strongest warning the FDA can require a medication to have on its packaging, advising consumers about serious side-effects and life-threatening risks associated with the drug.

The researchers noted that “new drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval.” As a result, they advised that “the ultimate solution is stronger U.S. drug approval standards. In the interim, with the rare exception of truly breakthrough therapies, doctors should preferentially prescribe drugs that have been on the market longer and hence have a more established track record of safety.”

J. Alan Welch: Attorney. Pharmacist. Brunswick’s Defective and Dangerous Drug Lawyer

Most law firms rely on outside health care experts, such as doctors, pharmacists and nurses, to review potential medical or pharmaceutical-related legal claims. It is relatively rare for an attorney to possess the medical, pharmacy and scientific background necessary to examine medical records to determine whether a client has an actionable claim. As a pharmacist, I bring years of medical experience to the practice of law. Because I have an in-depth understanding of these issues, I help my clients understand how medicine and the law intersect. If you or a loved one has been harmed by a pharmacy error, drug defect or a medical professional’s negligence, contact me today at (912) 265-9811 to discuss your case.

This article has been prepared by J. Alan Welch Law for informational purposes only and does not, and is not intended to, constitute legal advice. The information is not provided in the course of an attorney-client relationship and is not intended to substitute for legal advice from an attorney licensed in your jurisdiction.

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