HYDE-SMITH WELCOMES FDA APPROVAL OF FIRST GENERIC OF RESTASIS

Press Release

U.S. Senator Cindy Hyde-Smith (R-Miss.) today welcomed approval by the Food and Drug Administration (FDA) of a generic alternative to the eye-drop prescription drug Restasis, a decision she has long sought as part of her efforts to fight for more affordable prescription medications.

Hyde-Smith targeted the manufacturers of Restasis in a 2020 floor speech advocating for passage of the Prescription Drug Pricing Reduction Act, citing it as an example of pharmaceutical industry practices that make drug prices unaffordable for many Americans.

"I'm thrilled that patients who rely on Restasis will finally have access to a more affordable alternative. There are real world consequences when pharmaceutical companies are too interested in maximizing profits and patients are forced to go without unaffordable medicines," said Hyde-Smith, a member of the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee.

"Prescription drug prices remain a major issue for my constituents, and I will continue to look for ways to make those life-saving medications more affordable," she said.

Sally Choe, Ph.D., director of the FDA Center for Drug Evaluation and Research Office of Generic Drugs, on Wednesday announced it had approved the first generic of Restasis.

"Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes," Choe said.

In her 2020 speech, Hyde-Smith was critical of the 250 percent increase in the average wholesale price of Restasis over 10 years while its manufacturer, Allergan, maneuvered to fend off generic alternatives.

"Allergan has undertaken, what I consider, one of the most blatantly anticompetitive schemes in the history of the pharmaceutical industry. Fearing competition after its Restasis patents expired in 2014, Allergan transferred the patents to a Native American tribe in an attempt to use the tribe's sovereign immunity to shield Allergan against competition from lower-priced generic alternatives," Hyde-Smith said at the time.

"This case went all the way to the United States Supreme Court in 2018. Even though the Supreme Court ultimately ruled that this scheme was illegal, the company's underhanded ploy successfully delayed competition while it continued to reap outrageous profits from Restasis--costing the U.S. healthcare system over $2 billion per year because of Allergan's monopoly pricing," she said.

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