U.S. Senator Susan Collins Questions FDA's Head of Pharmaceuticals about Skyrocketing Price of EpiPen®

Sen. Collins: It strikes me that Mylan is ‘gaming the system’

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Washington, D.C. —U.S. Senator Susan Collins, the Chairman of the Senate Aging Committee, questioned Dr. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER), about the skyrocketing price of EpiPen® during a Senate hearing this afternoon. 

Chairman Collins and Ranking Member Claire McCaskill wrote to Mylan Pharmaceuticals to request answers and information about the company's drastic price increase of EpiPen® by 480 percent since 2008. Following the Aging Committee’s inquiry, as well as interest from other congressional Committees, Mylan announced plans to introduce what’s called an “authorized generic” of EpiPen. An authorized generic would be marketed under the same New Drug Application as the brand-name prescription drug that has already been approved by the FDA.

In her question to Dr. Woodcock, Senator Collins stated that Mylan’s decision to introduce an authorized generic “strikes me as gaming the system.” Senator Collins highlighted that she was aware the FDA had approved other competitors to EpiPen®, and that one has been recalled voluntarily due to problems, “but in general the idea of a brand-name company simply swapping the label on its product and then issuing it as a generic strikes me as greatly reducing the incentive for a true first generic to come on the market. Could you comment?”

In response, Dr. Woodcock noted that while she is not an economist, it “would depend on how much money a generic company thought they could make in the market based on what they could price their generic at.” Dr. Woodcock continued that “so far [the FDA] ha[s] noted 980 authorized generics that [they’ve] been notified about for different drugs. So it appears to be a relatively common practice in the industry.”

Senator Collins underscored that this area “does need more examination as far as its impact on discouraging a true first generic or second generic to come onto the market.”

Under Chairman Collins’ and Ranking Member Claire McCaskill’s leadership, the Aging Committee conducted a months-long investigation into the pricing of certain prescription drugs. As a result of information they uncovered during the investigation, Senators Collins and McCaskill introduced legislation that would help ensure that a clear process is in place for the Food and Drug Administration to prioritize the review of certain generic drug applications, incentivizing lower-price generics to enter the market to compete with monopoly drugs.