Gus Bilirakis Scores a Win as FDA Approves Generic EpiPen

Generic EpiPen gets a green light from the FDA


The U.S. Food and Drug Administration (FDA) is backing a proposal from a Florida congressman for a generic EpiPen.

Back at the start of last year, U.S. Rep. Gus Bilirakis, R-Fla., teamed up with U.S. Rep. Kurt Schrader, D-Oreg., to bring out the “Lower Drug Costs Through Competition Act” which they insisted “will incentivize drug makers to develop generic drugs when competition currently does not exist, or when there is a drug shortage.”

The FDA announced it was approving a generic EpiPen last week.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. as part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb on Thursday.

“This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” Gottlieb added. “The path to developing generic drug-device combination products like this one is challenging. We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines. Many of these steps were outlined in our Drug Competition Action Plan, announced last year. We’re especially committed to the development of generic copies of complex products. These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval. We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.”

Bilirakis’ office noted that the Florida congressman’s proposal “reformed the FDA Office of Combination Products as a result of this exchange with FDA officials” and noted the Office of Combination Products “manages the approval of Complex drug-device combination products (e.g., auto-injectors, metered dose inhalers).

“The EpiPen, a life-saving drug for millions of Americans, is an example of a combination product,” Bilirakis’ office noted. “The company that manufacturers the EpiPen, Mylan Pharmaceuticals raised the cost of the EpiPen by 400 percent, making it unaffordable for many families. Traditionally, there has not been a generic version of the EpiPen available on the market. However, thanks to the reforms championed by Bilirakis, the FDA just announced that it has approved the first generic version of the EpiPen, used to treat allergic reactions.”

The congressman weighed in on the FDA’s decision on Monday morning.

“Too often we have seen the price of lifesaving medication skyrocket due to bad actors taking advantage of monopolies in the market,” Bilirakis said. “The dramatic spike in cost for medications, like the EpiPen, prompted me to push for these critical reforms. Sick people should never be held hostage so a pharmaceutical company can increase its’ profits. I am thrilled that my legislative efforts are already translating into lower costs for patients and look forward to seeing the reduction of cost for many more Rx drugs.”

Earlier this month, the FDA announced it was approving the first approved the first medication allowed by Bilirakis’ law.

“The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation,” the FDA announced on Wednesday. “This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.”


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