Letters, Testimony & Comments

March 1, 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health Insurance Program P.O. Box 85200 Austin, TX 78708 Comments on the Proposed Rule Regarding Specialty Drugs...
February 29, 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the "concept paper on the revision of the guideline on similar biological medicinal product."...
February 29, 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on the FDA Report on Good Guidance Practices: Improving Efficiency and Transparency. BIO represents more than 1,...
February 27, 2012
BIO Public Statement: National Patient and Stakeholder Dialogue Thank you for the opportunity to present comments on behalf of the Biotechnology Industry Organization, which supports PCORI's goal of increasing the availability of...
February 21, 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 notice, “Establishing Timeframes for Implementation of...
February 17, 2012
If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can...
February 17, 2012
Centers for Medicare & Medicaid Services  Re:  Docket No. CMS-5060-P:  Proposed rule implementing Section 6002 of the Affordable Care Act (Pub. L. 111-148, as amended by Pub. L. 111-152)  Dear Sir or Madam:...
February 16, 2012
The Honorable Lisa P. Jackson Administrator Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 Dear Administrator Jackson, On behalf of our advanced and cellulosic biofuel member...
February 14, 2012
BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission. Priority Foreign Country: BIO requests USTR to elevate Turkey to a Priority Foreign Country due to new alarming issues...
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...