FDA generic drug approvals reach record high in fiscal year 2019

Oct. 17, 2019

According to a statement from the Acting Commissioner of Food and Drugs - Food and Drug Administration, Norman E. "Ned" Sharpless MD, affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public's health.

Safe, effective and high-quality generic drugs play a vital role in our healthcare system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the healthcare system about $293 billion.

The FDA’s ongoing efforts under the Drug Competition Action Plan and the Generic Drug User Fee Amendments, the FDA has built a thriving generic drug program. While the FDA expects to see highs and lows in our approval numbers from month to month based in part on what is submitted to us for assessment, the fiscal year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals).

This broke the all-time record of 971 for fiscal year 2018. Additionally, in fiscal year 2019, 125 applications were approved for first generics of medicines that had no generic competition. First generics approved in fiscal year 2019 included an emergency opioid overdose treatment and drugs to treat conditions such as pulmonary arterial hypertension, breast cancer, seizures, depression and various infections. Also, of note, the FDA is approving increasing numbers of complex generic drugs, which are harder to copy and traditionally have lacked competition.

Moreover, it is not enough to just bring more generics to market. Consumers must also have confidence in the safety and quality of generic medicines. The FDA’s scientific review and assessment process for generic drug applications ensures that generic medications perform the same way in the human body, have the same active ingredients and have the same conditions of use as their counterpart name brand medication. Generic drugs are held to high approval and manufacturing standards and once a generic medication is approved, the FDA continues to monitor its safety, effectiveness and quality, including through periodic inspections of manufacturing plants, careful evaluation of post-approval changes proposed by manufacturers and thorough assessment of any adverse event reports.

The value of our generic drug program runs deep, and the FDA is engaged in a number of efforts to help ensure the program remains vibrant.

In the coming months, FDA plans to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers.