The US FDA has prioritized streamlining the regulatory process for generic drugs and positioning generic drugs in markets in which they have no existing competition. In 2012, the backlog for generic drug applications was over 2,800; as of January, FDA commissioner Scott Gottleib stated that the backlog is now in the low 100s. Mr. Gottleib expressed that his goal is to remove the backlog all together so that companies would be able to receive a review for their generic drugs immediately after applying with the FDA.

Part of the FDA’s streamlined approach is highlighting applications for generic drugs that have only 1 competitor in the market, pledging to create more choices of generic drugs for consumers who currently can only access a single brand. The FDA is also working on simplifying the process for generic drugs companies for proving that their generic version is identical to the branded drug their generic drug is based on.

In October 2017, the FDA approved 763 generic drug applications, compared to 651 approvals in 2016 and 492 approvals in 2015. Near the end of 2017, Mr. Gottleib stated that the FDA approved over 1,000 drugs, the highest number of generic drugs approvals in one year in the Administration’s history. He stated the FDA also approved the highest number of novel drugs in 2017 in its history at 46, as well as the largest number of novel devices and first gene therapies.

Source: The Washington Post