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BIO Submits Comments to the Centers for Medicare and Medicaid Services (CMS) Regarding the Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond; Proposed Rule (CMS-9949-P)

May 30 2014
April 10, 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: Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond; Proposed Rule (CMS-9949-P)   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) on March 21, 2014, entitled “Exchange and Insurance Market Standards for 2015 and Beyond” (the “Proposed Rule”).[1]   BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.[2] [1] 79 Fed. Reg. 15,808 (March 21, 2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012), available at: http://www.cbo.gov/sites/default/files/cbofiles/attachments/43741-MedicalOffsets-11-29-12.pdf.   

BIO Submits Comments on Draft Accelerated Approval Labeling Guidance

May 26 2014
 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.

TESTIMONY OF SARA RADCLIFFE ON BEHALF OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE U.S. HOUSE OF REPRESENTATIVES ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH HEARING

May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.

BIO Submits Comments on Draft Analytical Procedures and Methods Validation Guidance

May 19 2014
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 Analytical Procedures and Methods Validation for Drugs and Biologics.”

BIO Submits Comments on FDA's Action Plan for Collection, Analysis, and Availability of Subgroup Data

May 15 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.

BIO and the Advanced Ethanol Council Send Letter to White House RE:Maintaining the Methodological Integrity of the RFS

May 15 2014
On May 15, 2014, the Biotechnology Industry Organization (BIO), the Advanced Ethanol Council, and associated signatories sent a letter to the White House expressing concern about the Administration’s impending decision around the Renewable Fuel Standard (RFS).

BIO Submits Comments on Considerations for Design of Early-Phase Clinical Trials for Cell and Gene Therapy Products

May 9 2014
BIO commends FDA on the release of this Draft Guidance, which will help to increase the efficiency of early clinical research for, and ultimately facilitate the development of, cellular and gene therapy (CGT) products. 

BIO and PhRMA Submit Joint Comments to FDA on Electronic Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

May 9 2014
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.

Fuels America Sends Letter to President Barack Obama RE: the National Climate Assessment Report

May 8 2014
On May 8, 2014, Fuels America, which BIO is a member, sent a letter to the White House commenting on the most recent announcement of the National Climate Assessment report.  

Reprints: BIO Comments on Distributing Scientific and Medical Publications on Unapproved New Uses

May 1 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance),1 BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain truthful and non-misleading information, including new information about the uses of approved drugs, biologics and medical devices. In addition, BIO supports FDA’s inclusion in this Revised Draft Guidance of recommendations regarding manufacturer provision of medical journals and texts, as well as Clinical Practice Guidelines (CPGs), that similarly contain truthful and non-misleading information, including new information, about the uses of approved drugs, biologics, and medical devices.