In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review speed and other reform-related changes, such as those affecting drug development times or the probability of approval, have increased the likelihood of initial U.S. drug launches. Overall, the results suggest that PDUFA did improve U.S. patients' access to new medicines by encouraging more first drug launches in the U.S. market.
Mary K. Olson,
PDUFA and Initial U.S. Drug Launches,
Mich. Telecomm. & Tech. L. Rev.
Available at: https://repository.law.umich.edu/mttlr/vol15/iss2/3