BIO Submits Comments to the Office of Science Technology and Policy (OSTP) on the Bioeconomy

The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the world. The comments were recently highlighted by Tom DiLenge, president of BIO’s Advocacy, Law & Public Policy Division, during The White House Summit on America’s Bioeconomy, which included leaders from industry, academia, and the government.

BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule

BIO offers comments on the following areas in the proposed rule, with an emphasis on ensuring that Medicare beneficiaries have access to the full range of items and services necessary to their health: • BIO appreciates the opportunity to comment on the agency’s future consideration of bundled payments under the PFS but urges CMS to prioritize patient access to appropriate therapies and to weigh the results of other demonstrations underway rather than attempting to swiftly implement bundled payments. • BIO supports the proposal to retain more granular payments for Evaluation and Management (E/M) services, which we think will support access to appropriate care for the sickest patients. • BIO appreciates the efforts CMS is making to treat patients with opioid addiction and offers comments about the agency’s proposals in this area, again with an emphasis on ensuring patient access to appropriate care.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

On September 27, BIO submitted final comments in response to the CY 2020 Outpatient Prospective Payment System Proposed Rule. BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. BIO has evaluated each of CMS's proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter. 

Proposed CFIUS Regulations Threaten Investment in America’s Life Sciences

“BIO fully supports the role of CFIUS in ensuring appropriate national security screening of certain foreign investments, but any rules must not discourage the entrepreneurial spirit that has made America the global leader in biopharmaceutical innovation,” said Tom DiLenge, president of BIO’s Advocacy, Law & Public Policy Division.

Nonpartisan Budget Experts Warn Speaker Pelosi’s Drug Pricing Bill will Stifle the Development of New Medicines

BIO’s President and CEO Jim Greenwood issued the following statement after the Congressional Budget Office released an analysis confirming that H.R. 3 will lead to fewer new medicines for patients.

Biotechnology Innovation Organization Announces 2021 Leadership Transition

The Biotechnology Innovation Organization (BIO) today announced that industry veteran Jim Greenwood will step down as President and CEO of the world’s largest biotechnology organization after the 2020 election and help transition a new leader to represent the industry globally and to defend innovation from domestic political attacks.

RFS Proposal Supports Green Energy Breakthroughs

The Biotechnology Innovation Organization (BIO) today released the following statement on the administration’s proposal on the Renewable Fuel Standard. The following statement may be attributed to Stephanie Batchelor, vice president of BIO's industrial & environmental section:

Pediatrics: BIO Comments on FDA Draft Guidance on Rare Pediatric Priority Review Vouchers

September 30, 2019


ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies

September 30, 2019


ICH: BIO Comments on FDA Draft Guidance ICH E19 Optimisation of Safety Data Collection

September 25, 2019