The U.S. Food and Drug Administration announced that they are approving a generic EpiPen, which is a move brought on by the “Lower Drug Costs Through Competition Act” that Representative Gus Bilirakis cosigned.
The legislation promised to “incentivize drug makers to develop generic drugs when competition currently does not exist, or when there is a drug shortage.”
In response to the FDA’s announcement, Bilirakis commented that “Too often we have seen the price of lifesaving medication skyrocket due to bad actors taking advantage of monopolies in the market. 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.”
FDA Commissioner Scott Gottlieb explained that the “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. 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.”