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Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.

BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals. As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

BIO Applauds Legislation to Spur Investment in Start-ups

Washington, DC (September 12, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the introduction of the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.

PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

September 11, 2018

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BIO Announces Programming for the 17th Annual BIO Investor Forum

Amidst a healthy investment climate for biotech companies, BIO announces programming for the 17th annual BIO Investor Forum

BIO Urges EPA to Help Boost America’s Rural Economy

On Friday, August 17, the Biotechnology Innovation Organization (BIO) urged the Environmental Protection Agency (EPA) to use its authority under the Renewable Fuel Standard (RFS) program to strengthen America’s biobased economy.

BIO Comments on RFS Standards for 2019 and Biomass-Based Diesel Volumes for 2020

The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 (proposed rule).

BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs

Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD); Draft Guidance for Industry.”  

BIO Releases Statement on NGA’s Report on Prescription Drug Costs

Washington, DC (August 10, 2018) – Tom Dilenge, president of advocacy, law & public policy at the Biotechnology Innovation Organization (BIO), issued the following statement today after the National Governors Association (NGA) released a report outlining “potential state strategies” to address prescription drug costs...

Biofuel and Agriculture Groups Petition to EPA regarding Lost RFS Volumes from Small Refinery Exemptions

RE: Petition for Reconsideration of 40 C.F.R. §80.1405(c), EPA Docket No. EPA–HQ–OAR–2005–0161, promulgated in 75 Fed. Reg. 14,670 (Mar. 26, 2010); Petition for Reconsideration of Periodic Reviews for the Renewable Fuel Standard Program, 82 Fed. Reg. 58,364 (Dec. 12, 2017)