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FDA approves record number of generic drugs, claiming savings to the healthcare system

The FDA is also approving greater numbers of complex generic drugs, which are more difficult to replicate and traditionally lack competition.

Jeff Lagasse, Associate Editor

On Wednesday, the Food and Drug Administration announced that, in Fiscal Year 2019, the agency approved a total of 1,171 generic drugs, which is said is an all-time record. That follows a record 971 approvals in Fiscal Year 2018 and a record 937 approvals in Fiscal Year 2017.

Health and Human Services Secretary Alex Azar, citing a drop in the Consumer Price Index for prescription drugs, said the number of drug approvals issued by the FDA over the past three years have resulted in lower prices and more access to these medicines.

According to a statement from Normal E. "Ned" Sharpless, MD, the FDA's acting commissioner of food and drugs, the agency has also approved 125 applications for first generics of medicines that had no generic competition. In 2019, the FDA approved first generics that included an emergency opioid overdose treatment, as well as drugs to treat conditions ranging from breast cancer and seizures to depression and pulmonary arterial hypertension.

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Sharpless said the FDA is also approving greater numbers of complex generic drugs, which are more difficult to replicate and traditionally lack competition.

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


Safe, effective and high-quality drugs play a vital role in the healthcare system, said Sharpless, and increasing generic drug competition can help to reduce prices and improve access. Generic drugs account for about 90% of all prescription drug purchases in the U.S., and in 2018, generic drug competition accounted for savings to the healthcare system totaling an estimated $293 billion.

The agency touted a strong pipeline of generic drug applications and interest in developing drugs with inadequate competition.


Medicare Part D enrollees may pay more out of pocket for high-priced specialty generic drugs than their brand-name counterparts, according to research published in July by health policy experts at Vanderbilt University Medical Center and the University of North Carolina at Chapel Hill.

Researchers examined differences in brand-name and generic or biosimilar drug prices, formulary coverage and expected out-of-pocket spending across all of the Medicare Part D plans available in the U.S. in the first quarter of 2018.

The study, published in the July issue of Health Affairs, found that current Medicare Part D beneficiaries can have higher out-of-pocket spending for generics than their branded counterparts if they use expensive specialty drugs, and if the price differences between brands and generics are not large. This can be common for individuals prescribed specialty drugs typically used to treat rare or complex conditions such as cancer, rheumatoid arthritis or multiple sclerosis.


"Lower drug prices are an important part of delivering American patients the affordability they need and, ultimately, promoting better health," said Azar. "President Trump will continue to work to put American patients first through competition, negotiation, lower list prices, and lower out-of-pocket costs."

"We know it is not enough to just bring more generics to market," said Sharpless. "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," he said.

Twitter: @JELagasse

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