BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years

Regulatory NewsRegulatory News | 23 June 2016 |  By 

Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years.

The introduction of the politicized bill comes as President Barack Obama has been pushing to lower the exclusivity threshold since at least 2010, though none of those plans have materialized. However, Obama also supports the Trans-Pacific Partnership, which calls for eight years of exclusivity in the US but which would increase the number years of biologics exclusivity in some foreign countries, and which is still a major sticking point for negotiations of the trade deal.

Currently, under the Patient Protection and Affordable Care Act's (PPACA) Biologics Price Competition and Innovation Act (BPCIA), new biologics are eligible for 12 years of market exclusivity during which time the US Food and Drug Administration (FDA) cannot approve any biosimilars.

Republican control of the House and Senate means the Schakowsky measure and its companion bill are unlikely to pass, particularly as the industry group known as Biotechnology Innovation Organization (BIO) said Thursday that it “strongly opposes” the bill, the text of which has yet to be released.

Vice President for Federal Government Relations Jeanne Haggerty said in a statement: “This legislation would disrupt the careful balance, created by Congress with broad, bipartisan support in the Biologics Price Competition and Innovation Act (BPCIA), between the need to encourage investment in innovative, groundbreaking biological therapies and the desire to ensure that patients have increased choices offered by biosimilar products after a reasonable period of exclusivity for the innovator product.

“The majority of biotechnology companies are small, private start-ups, heavily reliant on venture capital investment. And these companies hold two-thirds of the industry’s innovative clinical pipeline. Undermining investment in these companies means undermining investment in the next biomedical breakthroughs for patients,” she added.

Industry-backed legislation introduced in the past has called to extend exclusivity periods to as long as 15 years in order to incentivize the development of new products for patients with little or no treatment options.

HR 5573


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