FDA Approves Drugs Quicker Than European Medicines Agency


The FDA reviewed and approved new drugs quicker than the EMA from 2011 to 2015.

President Donald Trump and other lawmakers have criticized the drug approval process in the United States, citing that it is too slow and keeps patients from receiving speedy access to treatments. There has been talk among some legislators considering a push towards reforming the approval process.

Additionally, the Prescription Drug User Fee Act (PDUFA), which sets the timeline for approvals, is set to expire in October 2017, and will likely be revised to speed approvals.

However, the argument that other countries have faster drug approvals than the United States has been called into question. A new study published by the New England Journal of Medicine compared the review times by the FDA and the European Medicines Agency (EMA) for new drugs approved between 2011 and 2015.

The authors gathered a list of drug approvals for both agencies and grouped the drugs by therapeutic area and orphan status. Then, the investigators examined key regulatory dates and compared median review times.

Between 2011 and 2015, the authors discovered that the FDA approved 170 new drugs, while the EMA only approved 144 new drugs. The therapeutic areas of approved drugs were observed to be similar between the agencies, according to the study.

The authors also discovered that the FDA designated 43.5% of new approvals as orphan drugs, while the EMA only designated 25%.

At the FDA, the median review time was 306 days, compared with 383 days at the EMA, confirming that the FDA reviews drugs faster, according to the study. The authors found that the FDA had quicker reviews for drugs that treat cancer, hematologic disorders, and orphan diseases.

Differences in review time were also found among drugs that were approved by both agencies. For the 142 drugs approved by the FDA and EMA, the median total review time was 303 days for the FDA and 369 days for the EMA, according to the study.

The authors discovered that for the approved drugs, the FDA’s regulatory reviews were typically 60 days shorter than the other agency.

These findings were similar to those discovered by the authors when examining the review process between 2001 and 2010, according to the study.

While there has been an increased focus on speeding up the drug approval process, these study results indicate that the FDA reviews and approves drugs faster than the EMA, which may not require regulatory reform.

“Our analysis provides reassurance that the FDA continues to complete regulatory reviews more quickly than the EMA and has the potential to inform discussions regarding the reauthorization of the PDUFA,” the authors concluded.

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