Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan

May 31 2018

May 31, 2018


Compounding: BIO comments on FDA Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

May 25 2018

May 25, 2018


BIO Written Testimony for House Financial Services Hearing on Legislative Proposals to Help Fuel Capital and Growth on Main Street

May 23 2018
Good morning Chairman Huizenga, Ranking Member Maloney, and Members of the Capital Markets, Securities, and Investment Subcommittee. My name is Brian Hahn, and I am the Chief Financial Officer of GlycoMimetics, Inc., a 48-employee public biotech company based in Rockville, Maryland. I am also the Co-Chair of the Finance and Tax Committee at the Biotechnology Innovation Organization (BIO), which represents GlycoMimetics and over 1,100 other growth-stage biotechs that are driving the search for the next generation of cures and breakthrough medicines. The ability of growing businesses to access the public markets, as supported by the JOBS Act, is of paramount importance to biotechnology innovation because investment capital is the lifeblood of scientific advancement. It costs over $1 billion to develop a single life-saving treatment, and most companies spend more than a decade in the lab before their first therapy is approved. During this long development process, virtually every dollar spent by an emerging biotech comes directly from investors. Expenses ranging from buy-in-bulk beakers to $150 million clinical trials are all funded by investment capital because biotechs remain pre-revenue through their entire time in the lab and the clinic.

BIO Submission to the China Section 301 Investigation - September 28, 2017

Apr 4 2018

BIO submitted comments to the Office of the United States Trade Representative (USTR) and the inter-agency Section 301 Committee regarding the investigation, initiated on August 18, 2017,...

BIO Comments on FDA Draft Guidance Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

Mar 27 2018

March 27, 2018


BIO Comments on Proposed Settlement Agreement Between EPA and Philadelphia Energy Solutions on RFS Obligations

Mar 26 2018
BIO is greatly concerned by the Department of Justice's and Environmental Protection Agency's proposed Settlement Agreement to resolve a dispute about the PES Holdings' obligations under the Renewable Fuel Standard.

Clinical Trials: BIO Comments on FDA Promoting the Use of Complex Innovative Designs in Clinical Trials

Mar 23 2018

Re: Docket No. FDA-2018-N-0049: Promoting the Use of Complex Innovative Designs in Clinical Trials


CMC: BIO Comments on FDA Draft Guidance Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products

Mar 22 2018

Re: Docket No. FDA-1995-D-0288: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry


BIO Written Testimony for House Ways and Means Hearing on Expired Tax Provisions

Mar 14 2018
BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the Alternative Fuel Vehicle Refueling Property, which expired at the end of 2017. BIO also supports the extension and expansion of the tax code to include the Qualifying Renewable Chemical Production or Investment Tax Credit and Master Limited Partnerships (MLP) to advanced biofuel and renewable chemicals.

BIO Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter

Mar 7 2018
BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To that end, we provide comments in the following areas: The specialty tier eligibility cost threshold should be increased for 2019 and in future years and the exceptions process expanded to ensure that the specialty tier does not discriminate against vulnerable beneficiaries;  Co-insurance in the Part D non-preferred drug tier can unduly limit access to care for patients with severe and complex diseases;  Increased enforcement of nondiscrimination should be used when evaluating benefit design in the MA and Part D programs;  Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA Part D plans;  MA and Part D plans should prioritize and increase access to vaccinations for Medicare beneficiaries;  The timeframes and processes for formulary updates should support the inclusion of new therapies;  Drug tier labels should be accurately reflective of the tier’s composition.  The inclusion of prescription drug costs in Medicare advantage uniformity flexibility should provide patient access to the most appropriate treatment;  Additional flexibility in design of maximum out-of-pocket costs should be considered to assist beneficiaries;  The availability of suitable plan offerings should be increased through removal of the meaningful difference requirements;      Additions to the Star Ratings are critical to accurate assessment of patient care quality; and  Efforts to expand coverage for certain subsets of products MA-PD plans should focus across all drugs offered under the Part D program.