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FDA Statement

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

FDA generic drug approvals reach record high in fiscal year 2019

For Immediate Release:
Statement From:
Statement Author
Leadership Role
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 health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.

Thanks to 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 that continues to impress me. I am pleased to report that our generic drug program is having another strong year. While we expect to see highs and lows in our approval numbers from month to month based in part on what is submitted to us for assessment, I’m delighted to share that our fiscal year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals). This breaks our all-time record of 971 for fiscal year 2018. Additionally, in fiscal year 2019 we approved 125 applications 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, we know 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 we are engaged in a number of efforts to help ensure the program remains vibrant. We’re encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition. In the coming months, we plan 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. We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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