Letters, Testimony & Comments

July 11, 2007
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the following comments regarding...
June 29, 2007
In light of the upcoming U.S.-China Joint Commission on Commerce and Trade (JCCT) meeting in August, the American Seed Trade Association (ASTA) and Biotechnology Industry Organization (BIO) would like to highlight three concerns regarding...
June 22, 2007
I'm writing on  behalf of the Biotechnology Industry Organization (BIO) in response to your invitation for public comments on questions pertaining to international efforts t0 harmonize substantive requirements of patient laws, dated May 3...
June 13, 2007
Re: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Non-Renal Disease Indications (CAG-00383N) Dear Dr. Phurrough: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the...
June 13, 2007
Dear Acting Administrator Norwalk: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule regarding the hospital inpatient prospective...
June 6, 2007
June 6th, 2007 The Honorable Nancy Pelosi Office of the Speaker H-232, US Capitol Washington, DC 20515 Dear Speaker Pelosi: As President & CEO of the Biotechnology Industry Organization (BIO), I am writing to express BIO’s...
June 6, 2007
Chairman Leahy, Ranking Member Specter, and Members of the Committee, I am pleased to testify before you today on the critically important topic of patent reform. On behalf of the Biotechnology Industry Organization, of which my company Alkermes...
June 1, 2007
BIO's Comments on the SACGHS draft report.
May 23, 2007
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft guideline The Requirements for First-in-Human Clinical Trials for Potential High Risk Medicinal Products. BIO...
May 16, 2007
Dear Chairman Baucus and Ranking Member Grassley:   We applaud your commitment to continue reviewing trade preference programs to identify areas for improvement. As you review these programs, we encourage Congress to consider improvements...
May 7, 2007
Dear Ms. English: We commend the National Vaccine Advisory Committee (NVAC) for addresssing the challenges of adolescent immunization. The dynamic of immunizations is changing from a model focusing on infants to one recognizing the increasing...
April 26, 2007
The Statement of the The Biotechnology Industry Organization On H.R. 1908, The Patent Reform Act of 2007 The United States House of Representatives Committee on the Judiciary Subcommittee on Courts, the Internet, and Intellectual Property...
April 25, 2007
The paper details the legal and regulatory implications of the many important differences between biologics and traditional "small molecule" drugs.
April 17, 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today on the success of the Prescription Drug User Fee Act (PDUFA) and the proposed enhancements for PDUFA IV. My...
April 16, 2007
Regarding their letter to Pharmaceutical Manufacturers on the definition of AMP used to calculate 340B ceiling prices.