Letters, Testimony & Comments

July 23, 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid technological advancement of clinical diagnostic applications. The approach to assessing the analytical...
July 19, 2011
BIO’s comments addressed maters such as HRSA’s application of the exclusion, operational concerns arising from the proposed interpretation, and covered entity compliance and documentation requirements.   
July 12, 2011
BIO sent a letter to U.S. House and Senate leaders commending Congress for its bipartisan support for the commercialization of renewable fuels and, in particular, advanced biofuels. In the letter, BIO stresses that Section 526 of the Energy...
July 12, 2011
BIO views this Draft Guidance as an important step in further implementing a process for safety labeling changes that ensures patients and their physicians have access to timely, relevant, and science-based prescribing information to make informed...
July 8, 2011
In this brief filed jointly with the Association of University Technology Managers and CropLife International, BIO explains that the current high burden of proof for invalidating a patent in court has deep historic roots in Supreme Court law, and...
July 7, 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-paying jobs. In his testimony, Mr. Hastings, demonstrated how regulatory uncertainty, longer drug development...
July 5, 2011
In the brief filed in support of neither party, BIO asserts that the existing Federal Circuit standard of liability for infringing a process patent when the steps of the patented process are practiced by multiple different entities is too...
July 5, 2011
BIO agrees with CMS that the proposed influenza vaccination standard will help increase vaccination coverage among patients, thereby reducing influenza morbidity and mortality. We also recommend that CMS include pneumonia vaccination and pertussis...
June 28, 2011
Today I'd like to tell you what we've been doing at BIO lately—we've been imagining. We've been imagining not just how biotechnology can heal, fuel, and feed the world—– but how we at BIO can make that happen...
June 27, 2011
Today, biotechnology companies have more than 600 new biologic medicines in development and biotechnology is behind about two-thirds of the new medicines in development. However, continued advancement in biotechnology and the life sciences...
June 23, 2011
BIO’s testimony details how the growth of agricultural biotechnology has provided numerous benefits to farmers, consumers and the environment, and highlights the potential for agricultural biotechnology to meet future demands and global...
June 15, 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Internal Revenue Service (IRS) on the...
June 14, 2011
Dear Chairman Smith: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager's Amendment to H.R. 1249, the America Invents Act. It is our strong desire to see this bill, as...
June 13, 2011
Dear Speaker Boehner and Leader Pelosi: We write to express our unified support for Section 22 of H.R. 1249, “The America Invents Act.” We heartily commend Judiciary Committee Chairman Smith, Ranking Democrat Conyers, Subcommittee...
June 9, 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments relating to the development of a user fee program for biosimilar and interchangeable biological...
June 9, 2011
BIO generally supports and agrees with FDA's statements that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the...
June 6, 2011
Re: Medicare Program; Medicare Shared Saving Program: Accountable Care Organizations; Proposed Rule [CMS-1345-P] Dear Dr. Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for...
May 31, 2011
BIO provides specific comments and requests clarifications on the text of the Guideline regarding the variability of immunogenicity, approaches for predicting and reducing immunogenicity, clinical consequences of immunogenicity, problems with...