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Pharmaceutical Industry Faces Shortening of Exclusivity

June 29th, 2016
DNA drugA new bill to cut the exclusivity period for new biologics by 5 years is getting some bipartisan support in Congress, which is giving its proponents hope that 2016 might be the year it passes.

Previous attempts to reduce the 12 year period in which a developer has the exclusive right to market and sell a biologic have failed to make it through Congress. Now, in the wake of public and political outrage over drug-pricing, a new bill to cut exclusivity to 7 years was introduced with Republican and Democrat sponsors.

Far too many Americans are being unfairly burdened by the skyrocketing costs of prescription drugs,” said Senator John McCain (R-Arizona), one of the sponsors in a statement. “It’s simply unacceptable that patients have to worry about filling a prescription because they can’t afford to pay for it.”

According to the sponsors, the "Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would foster competition and provide opportunity for more biologics to enter the marketplace and drive down costs.

Developers of biologics -- drugs made using organisms and DNA manipulation, and include vaccines, blood and blood components, allergenics and gene therapy -- benefit from having one of the longest exclusivity periods. Proponents of reducing the time say it will encourage other companies to develop biosimilars, which will increase competition and help keep prices in check.

Industry groups are already lining up for and against the bill, which is expected to get to the hearings stage later this summer.

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