Legislation provides critical regulatory relief to small, pre-revenue emerging companiesWashington, D.C. (February 12, 2018)— The Biotechnology Innovation Organization (BIO) announced its strong support today for H.R. 3978, the TRID Improvement Act. The bill includes a provision known as the Fostering Innovation Act, which offers much needed regulatory relief to small biotechnology firms. 

Report highlights the need to stimulate innovationto battle the opioid epidemicWashington, DC (February 12, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics. While many promising treatment approaches are in development, lower investment and pipeline breadth in pain and addiction relative to other disease areas with high societal health burdens demonstrates the need for incentivizing more research and clinical development in these areas.

Washington, DC (February 9, 2018) – – The Biotechnology Innovation Organization (BIO) applauds Reps. Mike Kelly (R-PA) and Brian Higgins (D-NY) for introducing H.R. 4993, the Vaccine Access Improvement Act, which would promote timely access to new first-in-class childhood and maternal vaccines. The legislation would update the tax code to ensure new first-in-class vaccines are promptly covered under the National Vaccine Injury Compensation Program (VICP). 

Washington, D.C. (February 09, 2018) – The Biotechnology Innovation Organization (BIO) and the South Dakota Biotech Association commend Governor Dennis Daugaard for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.Governor Daugaard signed Senate Bill 75 this week, following unanimous passage in both the South Dakota Senate and House. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support.  BIO and the South Dakota Biotech Association are grateful to the legislature and Governor Daugaard for their leadership on this issue.“Senate Bill 75 enjoys the support of physicians across South Dakota and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies.  This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer. "By signing this bill into law, Governor Daugaard has added South Dakota to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law.  Senate Bill 75 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.  BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.“We’re pleased to see…

Washington, DC (February 8, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding proposed changes to the Medicare Part D program in the announced budget deal.

The steady decline of America as an innovation-supporting economy is due to an unbalanced patent challenge system.  

Washington, D.C. (February 5, 2018) – The following statement may be attributed to BIO President & CEO James Greenwood:“I congratulate Andrei Iancu on his Senate confirmation to fill the position of Under Secretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (PTO).“The position of PTO Director is extraordinarily important, as it oversees a federal agency that is an indispensable element of the continued economic growth and innovation of American enterprise.“Strong and reliable patents are the lifeblood of the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines and more sustainable, bio-based energy and agricultural products. And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves. “I look forward to engaging with Director Iancu and his staff as BIO continues to push for balanced reforms to curb abusive anti-patent practices, protect the ability of patent owners to defend their inventions and businesses against infringement, and promote greater predictability and certainty of patent rights as a basis for investment in innovation.”

Washington, D.C. (January 30, 2018) – The Biotechnology Innovation Organization (BIO) is applauding a new agreement announced by the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to enhance coordination between the two agencies on program areas such as biotechnology.