Congressman Gus Bilirakis has been working to reduce the cost of prescription drugs for several years. He has authored multiple provisions within H.R. 2430, which was signed into law last August.
One of the provisions created an expedited approval process for generic drugs when no competitor exists on the market. The U.S. Food and Drug Administration (FDA) announced last week that it approved the first generic drug through this new process.
The second Bilirakis provision reformed the FDA Office of Combination Products, as a result of an exchange with FDA officials. This office manages the approval of Complex drug-device combination products, such as auto-injectors and metered-dose inhalers.
The EpiPen is an example of a combination product.
The company that manufactures 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, with the reforms, the FDA has announced that it has approved the first generic version of the EpiPen, used to treat allergic reactions.