BIO Strongly Opposes H.R. 5573

Bill would undermine critical work of biotechnology companies developing new cures and treatments

Biotechnology Innovation Organization (BIO) Senior Vice President for Federal Government Relations Jeanne Haggerty released the following statement regarding H.R. 5573 and companion legislation in the Senate, which would amend the Public Health Service Act to shorten the exclusivity period for innovative biological products from 12 to 7 years:

“BIO strongly opposes H.R. 5573 and its companion bill in the Senate. 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. Data exclusivity of 12 years is an essential incentive for the huge risks associated with biotechnology investment. 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.

“The legislative process that produced the current U.S. system was deliberate, thoughtful, and driven by rigorous analysis. The BPCIA received overwhelming support in Congress at the committee level and in both the full House and Senate. This legislation is a short-sighted attempt to undercut the critical work that innovator companies are doing and would, if enacted, deprive patients of many new treatments and cures in the future.”

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.