The U.S. Food and Drug Administration (FDA) approved the highest number of new drugs in 21 years, with 46 approvals in 2017 that was more than double in 2016.
The increase in approvals seems remarkable since very few make it to the Phase 2 and Phase 3 clinical trial for drugs. On the other hand, the increase does not indicate that the FDA’s review process for new medication has become less stringent.
Novelty Medicine
While the FDA maintains a strict review process, the agency has adopted an expedited approach for approving new drugs. It recently used one or more expedited review mechanisms for an estimated 60% of new drugs that were approved between 2001 and 2017.
The FDA only averaged around 31 new drug approvals per year between 2008 and 2016. The previous year’s increase may have represented the highest growth in two decades, but it still compares lower to the record number of 53 approvals in 1996. Many of the drug approvals comprised medicine for oncology, which suggested the ongoing development for finding a cure to rare illnesses.
Better Transparency
FDA Commissioner Scott Gottlieb said that the agency has looked into several ways on how to improve transparency for approving new drugs. For instance, a better review of clinical study reports (CSR) may improve the dissemination of information to patients and healthcare providers.
A pioneer evaluation project will seek to determine if the public has improved access to drug approval data, after releasing specific details from CSRs. The FDA will use up to nine recently approved new drug applications for the pilot program.
Drug manufacturers in the U.S. go through an extensive process before they gain approval for a new type of medicine. Clinical trials play an important role in the process, as the result may affect the FDA’s decision.