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In this article, the author expresses his views on issues related to the decision made by the U.S. Food and Drug Administration (FDA) to grant market exclusivity to URL Pharma for the colchicine drug. Colchicine is a drug manufactured by URL Pharma for the treatment of acute flares of gouty arthritis. Information on the 1938 Food, Drug, and Cosmetic Act is also presented.

The article discusses the breakthrough therapy designation created by U.S. Congress to expedite Food and Drug Administration testing as well as approval of drugs aimed at treating serious diseases. Manufacturers were allowed to employ many programs to combine different advantages which reduced cost of drug development.

The article discusses the access to injectable generic drugs, with focus on bacille Calmette-Guérin for bladder cancer. It notes the prospect of a sustained shortage or substantial price increase after a BCG manufacturer announces in November 2016 to exit the market in mid-2017. It illustrates the price increase of mitomycin, thiotepa, and valrubicin during the BCG shortage beginning in 2014. Also noted is payment reforms which could further stabilize the generic injectable agents market.

The article discusses the implications for patients of the creation of breakthrough therapy in the U.S. Food and Drug Administration Safety and Innovation Act to ensure the safety and effectiveness of marketed prescription drugs. Topics include prior government efforts to expedite the availability of new therapeutics, the benefits and risks of expanded access and early approval, and the rationale and potential outcomes of breakthrough therapy.