The FDA approved a record number of generics in 2019, following big 2018 and 2017 approvals. With the FDA reporting that generics now constitute nine of 10 prescriptions filled, these “[t]hree record-setting years of generic drug approvals by the FDA are playing a major role in delivering lower prices and more access to prescription drugs, as evidenced by a historic drop in the Consumer Price Index for prescription drugs,” said HHS Secretary Azar in a statement. The 3-year span included a total of 3,079 approvals of generic-drug applications.
“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,” said FDA Acting Commissioner Norman E. “Ned” Sharpless, MD.
In 2019, the agency approved a total of 1,171 generic drugs, including 125 applications for “first generics” of medicines that previously did not have a generic option. According to Sharpless, this year’s list of first generics, “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.”
The use of abbreviated new drug applications (ANDAs), a prioritization policy that grants expedited review of drugs with fewer ANDAs for the reference listed drug and no patents or exclusivities blocking approval, along with a published list of drugs for which there is currently no generic competition, have driven the increase in numbers.
A 2017 FDA study of the impact of generic drugs on the market found that generic competition lowered drug prices, and the entry of a second generic manufacturer into the market had the biggest impact on price. While the total number of generic drugs approved in 2019 includes competitors far beyond the second, the 125 first generics indicate a clear step toward increased accessibility.
Recent recalls due to nitrosamine contamination have increased concerns regarding the safety of generics, which Sharpless addressed head on. “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.” He noted that the FDA’s scientific review and assessment process for generic-drug applications evaluate whether generics function the same way in the body, have the same active ingredients, and have the same guidelines for use as the brand-name medication.
Even after approval, Sharpless said, “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.”
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