President Obama recently signed a bipartisan bill that authorizes Food and Drug Administration (“FDA” or “Agency”) user fees for five more years and establishes new user fees for the FDA’s review of generic drugs and biosimilar products.[1] The bill reauthorizes the Prescription Drug User Fee Act (“PDUFA” or the “Act”), a law originally passed by Congress in 1992. PDUFA permits the FDA to collect user fees from drug manufacturers to fund, among other FDA endeavors, new drug and medical device approval. The most recent reauthorization of the bipartisan bill, which increases the amount of money drug and device manufacturers must pay the FDA to review a new drug or device application, has gained the support of both Congress and the pharmaceutical industry.