Has The FDA Sacrificed Safety For Speed?

As the Ebola crisis rages on in West Africa, the FDA is under increased pressure to rush their approval of potential cures and ‘stands ready” to work with pharmaceutical companies. However, a new study has been published in Health Affairs that suggests the FDA’s commitment to speed comes at the cost of patient safety.

This study — a collaboration between The Cambridge Health Alliance/Harvard Medical School, Boston Medical Center/Boston University School of Medicine, City University of New York School of Public Health, and Public Citizen — reports that newer drugs have a one in three chance of receiving a black box warning or being withdrawn from the market.

The study examined drugs released since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which has been reauthorized four times since. This act allows the FDA to collect fees from pharmaceutical companies in exchange for an expedited approval schedule and has effectively cut the wait time for a new drug in half.

The study found that the number of withdrawals and black box warnings increased from 21 percent to 26 percent after PDUFA and suggests the FDA’s expedited process may be the culprit.  The study argues that, as a result, dangerous drugs are being marketed before their safety has been fully evaluated.

“The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” said study lead author Cassie Frank, MD, a physician at Cambridge Health Alliance and an instructor in medicine at Harvard Medical School.  “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available.”

Previous studies have been conducted, which found no significant change to drug safety before and after PDFUA. However, this newest study argues that the data collected before is unreliable since it was collected relatively soon after the passage of the act.  The full study published in Health Affairs studies every drug approved by the FDA over a drug’s thirty-five year time period (1975-2009).

According to The Wall Street Journal, the FDA has received the study and it is currently under review. According to a FDA spokesperson, the government association stands behind PDUFA, maintaining that the revenue generated by the law has vastly improved the existing system for evaluating drug safety.