Health Care Reform

The health reform debate is heating up and, in at least one respect, slowing down a bit.

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

March 7 2014
  March 7, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re:  Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program; Proposed Rule [CMS-4159-P]   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). BIO is the largest trade association to serve and represent the biotechnology industry in the United States and around the globe.  Indeed, BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations.   BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.    
November 5 2012
We write with the concern that under the statutory patent dispute resolution scheme, biosimilars sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification. As universities are commonly licensors of biological products, numerous university patents may be affected by biosimilar applications. We do not believe it is appropriate that our member institutions’ rights could be forfeited due to an inadvertent or intentional failure by a biosimilar applicant to notify the reference product sponsor, who in turn can notify the university licensor.
October 28 2013
BIO responds to a Senators letter to FDA Commissioner Margaret Hamburg, regarding naming standards for biosimilars - drugs that are similar to, but not the same as the innovator drugs they seek to replicate.
June 28 2012
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement on the ruling issued today by the U.S. Supreme Court regarding the Affordable Care Act.
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
March 22 2010
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement after passage of “The Patient Protection and Affordable Care Act of 2009."