Letters, Testimony & Comments

February 14, 2012
The Federal Circuit's majority panel decision in this case upsets the delicately balanced, congressionally created incentive system for reexamination.  It is inconsistent with the relevant statutes and imposes a rule that would create...
February 8, 2012
Re:    Draft Framework for the National Plan to Address Alzheimer's Disease Dear Ms. Glied:           The Biotechnology Industry Organization (BIO) is pleased to submit the following...
February 1, 2012
  Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this Subcommittee today. My name is Richard Pops and I am Chairman and CEO of Alkermes. I am here testifying on behalf of the...
January 31, 2012
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services' (HHS) pre-rule bulletin on the essential health benefit (EHB) provisions of the Patient Protection and...
January 30, 2012
  January 30, 2012 Azam Khan Deputy Chief of Staff, Office of the Under Secretary and Director United States Patent and Trademark Office, Alexandria, VA 22313   Re: Request for Comments on Additional USPTO Satellite...
January 20, 2012
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed...
January 20, 2012
Re:      CED Public Solicitation Dear Dr. Jacques:             The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers...
January 17, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Proposed Rule: Orphan Drug Regulations.”  As an...
January 9, 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Retrospective Review under Executive Order...
December 31, 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on “Concept paper on the revision of the guideline on similar biological medicinal products containing...
December 23, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public...
December 16, 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee program for biosimilar and interchangeable biological product applications (BsUFA).  BIO supports FDA...
December 13, 2011
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS or the Agency) Draft Environmental Impact...
December 9, 2011
By Electronic Submission To the State Intellectual Property Office, The Biotechnology Industry Organization (BIO) appreciates this opportunity to provide comments to the State Intellectual Property Office (SIPO) of the People’s Republic...
December 2, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Proposal for Public Comment to Increase Transparency By Promoting Greater...
December 1, 2011
On December 1, BIO submitted written testimony to the Senate Committee on Banking, Housing, and Urban Affairs on the importance of implementing policies that will spur job growth through capital formation while protecting investors.  
November 28, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...
November 23, 2011
Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Medicare Coverage document entitled “Potential NCD Topics....
November 16, 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-Chair Madam Chairwoman and Members of the Commission: Good morning.  My name is Russell Medford, and I...