Letters, Testimony & Comments

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...
August 13, 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The comments recognize that these dual statutes governing pediatric research have been remarkably successful...
August 9, 2010
BIO encourages ASPE to proceed with caution on the creation of an inventory and raises some methodological and structural considerations.
August 3, 2010
SECTION 1. PURPOSE This notice establishes the qualifying therapeutic discovery project program under § 48D of the Internal Revenue Code (Code), as added to the Code by section 9023(a) of the Patient Protection and Affordable Care Act of...
August 3, 2010
BIO advocated for the recently enacted new Therapeutic Discovery Project Credit program, which was created as a unique opportunity for companies in a loss position to earn tax credits for up to 50 percent of many of their R&D activities, and...
August 2, 2010
BIO urges the Court of Appeals for the Federal Circuit to adopt a new rule that better accounts for the public interest in valid and clear patent rights than the inequitable conduct doctrine.
August 2, 2010
BIO supports the view that a system of genetic test registration is necessary to provide stakeholders with information about the spectrum of tests being offered. Making test performance characteristics and reference information (analytical...
July 30, 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.
July 30, 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.
July 26, 2010
Members of BIO, TechNet, and NVCA commend the Senate for rejecting the rescission of $2 billion from pandemic influenza and the BioShield Special Reserve Fund (SRF) that the House included in its amendment to HR 4899, the FY2010 Supplemental...