Letters, Testimony & Comments

September 29, 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial Policy and Promotion’s (DIPP) discussion paper on compulsory licenses published on August 24, 2010....
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO)...
September 23, 2010
Re: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals [DoD-2008-HA- 0029; 0720-AB22] Dear Captain Blanche: The Biotechnology...
September 20, 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for the Biotechnology Industry Organization (BIO). We represent 1,100 member organizations that research, develop...
September 20, 2010
Dear President Obama: We are writing to ask for your support to provide additional guidance to the Department of Energy’s (DOE) Loan Guarantee Program (LGP) to unlock funding for advanced biofuels, biochemicals and bioproducts projects....
September 17, 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act Please Refer to OCIIO-9992-IFC Dear Mr. Mayhew: The Biotechnology...
September 8, 2010
BIO urges the Court of Appeals for the Federal Circuit to exclude the disclosure of the patent specification to support a finding of double-patenting.
September 7, 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug interactions, special populations, unique toxicities, and study design.
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
August 30, 2010
BIO agrees that prioritizing the select agents into stratified tiers based on an assessment of relative risk would be appropriate. We feel that such an exercise would help set federal government research, development and procurement priorities....
August 25, 2010
BIO supports the draft Biennial Implementation Plan’s goal to rapidly develop and adopt countermeasures that mitigate health consequences of a chemical, biological, radiological and nuclear attack.
August 24, 2010
BIO is concerned about problems in CMS methodology that continue to create instability in reimbursement for separately payable drugs and biologicals.
August 24, 2010
Although BIO recognizes that preventing a significant cut in physician payment rates is largely within Congress' authority, we urge CMS to do anything in its power to mitigate cuts and ensure that Medicare beneficiaries continue to have access...
August 19, 2010
BIO comments to the Environmental Protection Agency on the 2011 proposed renewable fuel standard volumes. The current proposed rule from EPA waives the cellulosic biofuel volume for 2011 to 5-17.1 million gallons (6.5-25.5 million gallons ethanol...
August 16, 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines at first dollar.
August 16, 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines at first dollar.
August 15, 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO companies should play a key role in working with the FDA as they develop plans regarding the oversight of LDTs....
August 13, 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare delivery system and improvements to the process for selecting, modifying, and assessing REMS. BIO recommends...