Home > Blog > Jama States That FDA Too Quick To Approve Pradaxa

Is the FDA’s push to approve drugs more quickly costing too much in the way of patient safety?  According to an article published in the Journal of the American Medical Association by two drug-safety experts, the answer is yes.

They cite three drugs, including the controversial blood thinner Pradaxa, that were approved in an accelerated process and have resulted in serious patient safety issues.

Let’s start with Pradaxa, a very popular blood thinner that was approved as an alternative to warfarin, an anticoagulant that has been used for decades.  Pradaxa does not require the level of monitoring that warfarin does, but the bleeding risk that it poses is much more serious because there is no reversal agent available in bleeding emergencies as there is with warfarin.

The authors of the article propose that the FDA do more to balance accelerated review and safety by requiring drug companies to produce safety and effectiveness data soon after the drug is approved.  If this isn’t done, they recommend automatic withdrawal of the drug from the market.  This is the only way to ensure that drug companies have the proper incentives to ensure a drug’s safety.

Another drug that the authors cite is Caprelsa, used to treat advanced thyroid cancer.  FDA director Janet Woodcock states that the cancer community has expressed its willingness to take risks with safety for quicker access to new treatments, but the authors point out that the drug was so toxic that the overall survival of patients was no different with the drug than with placebo.

The final drug that the study discusses is Fingolimod, a drug approved for multiple sclerosis.  Apparently, there were seven major safety issues that came to light during testing, including very serious effects on heart rate, opportunistic infections, and possible cancer risks.  Safety concerns severely limited testing, and therefore only the lowest dose of the medication was pursued for approval.

This is not the first study to question the FDA’s ability to balance safety and efficiency, nor will it be the last.  This is an ongoing issue for the FDA and has real implications on our public health and health care costs.  While the government is right to want to keep the approval of innovative medications from being bogged down in a bureaucratic mess, it also can’t dismiss the reasons behind extensive testing requirements.

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