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FDA’s Faster Drug Approval Process Linked to Safety Issues

In 1992, the FDA sped up its drug approval process with the passage of the Prescription Drug User Free Act (PDUFA).  Overall, the PDUFA allowed the FDA to collect large fees from prescription drug companies to fund the drug approval process.  In return for these “user fees”, the FDA must meet a certain set of benchmarks during the approval process; particularly, the speed at which a drug is approved.  The primary argument was that prior to the imposition of “user fees”, the FDA could not approve drugs for distribution oon the market in a timely manner, leading to dissatisfaction among consumers, prescription drug manufacturers, and the FDA.  However, since that time, the number of “black box warnings” and drug withdrawals have increased, according to recent research conducted by scientists from the Cambridge Health Alliance in Massachusetts.

Scientists Look at Hundreds of Drugs Approved During Thirty Year Stretch

The researchers looked at 748 drugs approved between 1975 and 2009.  They compared the safety issues of drugs approved prior to PDUFA in 1992 and those approved after and found distinctive differences.  Specifically, of the drugs approved after PDUFA, 114 or 15.2% received a black box warning and 32 or 4.3% were withdrawn from the market altogether for serious safety reasons.  Overall, a total of 208 drugs either received a black box warning or were withdrawn from the market; half of the warnings were issued within 12 years of PDUFA and half of the withdrawals occurred within 5 years of PDUFA.  The rate of black box warnings or withdrawals also climbed from 21.2 per 100 boxes to 26.7 per 100 after PDUFA.

FDA Issues Statement in Response to Research

While the researchers say that the best solution to the decrease in safety of prescription drugs is stronger U.S. drug approval standards, the FDA thinks otherwise.  In response to the publication of the research in the August issue of Health Affairs, the FDA issued a statement.

PDUFA has enhanced pre-market review and created a modern post-market drug safety system that follows products across their full life cycle. Specifically, PDUFA provides FDA revenue to hire additional reviewers and support staff and upgrade its information technology systems to maximize the efficiency of the application review process for new drugs and biological products without compromising FDA’s high standards for approval.

Additionally, PDUFA funding has helped the FDA modernize and transform the post-market drug safety surveillance system. It has helped ensure the safety of drugs after they are approved for as long as they remain on the market and [has] increased FDA’s drug safety surveillance capacity. FDA has been able to adopt new scientific approaches and improve the utility of existing tools for the detection and prevention of adverse events, including obtaining access to the best available databases to better analyze drug safety signals.

It does not appear that the FDA will be reversing its stance on the safety of its drug approval process, despite evidence to the contrary.

If you think you’ve been a victim of  Pharmacy / Pharmacist Negligence please contact Church Wyble immediately.

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