BIO Food and Agriculture Section Comments to FDA on Review of Existing General Regulatory and Information Collection Requirements

Feb 8 2018
February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register entitled “Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration,” as well as several related Center-specific notices.

Pediatrics Rare Disease: BIO Comment Letter on FDA Draft Guidance Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model

Feb 8 2018

Re: Docket No. FDA-2017-N-6476: Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability...

BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

Feb 2 2018

DSCSA: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Jan 26 2018

Re: Docket No. FDA–2017–D–6526: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance For Industry


BIO Submits Comments Re: Medicare CY 2018 Part D Call Letter

Jan 25 2018
BIO strongly supports CMS’s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and biologicals for Medicare beneficiaries in MA and Part D plans. To further improve access to crucial therapies and immunizations for these patients, we urge CMS to consider the following comments, discussed in more detail below: Cost-sharing in the Part D specialty tier can unduly burden patients with severe, complex diseases and is exacerbated by the fact that the dollar-per-month threshold on the specialty tier allows a broad range of therapies to be included. While we appreciated the effort in 2017 toward increasing the threshold, BIO urges CMS to continue to substantially increase the threshold for 2018 and beyond. BIO also urges CMS to review the specialty tiers to ensure they do not discourage enrollment by certain Part D-eligible individuals. CMS should continue to seek information on the Part D tiering exceptions process and ensure that tiering structures do not impede beneficiary access to medically necessary and appropriate treatments. CMS should ensure that the timeframe and process for formulary updates reasonably allows for the addition of new therapies. CMS should work to make Medicare Plan Finder inclusive of the most up to date formulary information to best inform beneficiary prescription drug coverage choice. CMS should finalize the proposal to include a new display measure around the adjudication process and should continue efforts to further increase transparency around this process to provide patients with appropriate access to needed medicines. CMS should evaluate access to specialty pharmacies in considering network adequacy and patient access issues. CMS should continue to encourage increased beneficiary vaccination rates and ensure MA plans deem vaccinations provided by pharmacists, in accordance with state laws, as in-network providers for these services. CMS should finalize the movement of the High Risk Medication (HRM) measure from the Star Ratings to the display measures. CMS should ensure that innovative model testing in the Medicare program works to maintain or improve beneficiary access to appropriate care and treatment. CMS should look to include display measures consistent with the goals of the National Action Plan for Adverse Drug Event Prevention in future years. CMS should finalize the clarification around "reference-based pricing"2 in Part D beneficiary cost-sharing arrangements. CMS should look to further ensure market stabilization for the dually eligible population in Puerto Rico.

BIO Submits Comments Re: Medicare CY 2019 Part D Proposed Rule

Jan 25 2018
BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most appropriate course of treatment. Our comments, detailed further in the balance of this letter, focus on the following areas: Request for Information to Require Pass through of Manufacturer Rebates at the Point of Sale to the Beneficiary Implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA) Treatment of Follow-On Biological Products as Generics for Non-LIS Catastrophic and LIS Cost-Sharing Revisions to Part D Tiering Exceptions Expedited Substitutions of Certain Generics and Other Midyear Formulary Changes Maximum Out-of-Pocket Limit and Cost-Sharing Limits for Medicare Parts A and B Services Flexibility in the Medicare Advantage Uniformity Requirements Any Willing Pharmacy Standards Terms and Conditions Medicare Advantage and Part D Prescription Drug Program Quality Rating System MA/Part D Artificial Limits

REMS: BIO Comments on Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document

Dec 12 2017
December 11th, 2017 ...

BIO Submits Comments Re: ICER Proposed Revisions to its Value Framework for Treatments for Ultra-Rare Diseases

Dec 11 2017
BIO appreciates the opportunity to comment on these proposed revisions. Patients living with rare diseases often experience significant unmet medical need due to the lack of knowledge about how these diseases are caused or inherited and their progression. That those suffering from rare diseases are predominately children raises issues around how society prioritizes and develops treatments for these conditions. We believe there are significant challenges in reconciling existing population-level value assessment methodologies with the varied healthcare contexts and deeply personal patient-level treatment decisions faced by patients afflicted with rare diseases, their families, and their clinicians. For a number of reasons, applying a patient-centric lens when considering the value of treatment is especially important when considering rare diseases.

BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

Dec 8 2017
December 7, 2017 ...

BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"

Dec 5 2017
The Biotechnology Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on January 18, 2017 ("Draft Guidance").