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ICH: BIO Submits Comments on S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines

Apr 11 2019
One area where the guideline is of particular relevance to BIO, and is thus appreciated, is in establishing both clarity and flexibility around the need and value of studies conducted in nonhuman primates. The language in Section 3.3 that acknowledges the limited value of dedicated studies in postweaning juvenile NHP is supported, as is the final paragraph in Section 4 which specifically addresses the situation of “pediatric first” clinical development in neonates.

REMS: BIO Submits Comments on REMS Assessment: Planning and Reporting

Apr 11 2019
April 2, 2019 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2018-D-4628-0001: REMS Assessment: Planning and Reporting 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on REMS Assessment: Planning and Reporting.

BIO's 2019 Special 301 Submission

Mar 27 2019

Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual...

BIO Comments on Earnings Releases and Quarterly Reports

Mar 25 2019
The Biotechnology Innovation Organization (BIO) responded to the SEC’s request for comments on the nature and timing of disclosures that reporting companies are required to provide in their quarterly reports. BIO believes that the current quarterly reporting framework places an unhealthy emphasis on meeting or exceeding short-term forecasts, which engenders an inefficient outlook on short-term results. Due to the lengthy timeline for potentially life-saving drug discovery, which averages 10-15 years, biotech companies and their investors would be better served by a less frequent (e.g. semiannual) reporting regime that prioritizes long-term value creation. Biotech companies have unique business models and would benefit from scaled disclosure whereby smaller reporting companies (SRCs) and emerging growth companies (EGCs) report on a less frequent (e.g. semiannual) basis while preserving the flexibility to adopt more frequent (e.g. quarterly) reporting as they advance toward commercial stage.

PFDD: BIO Comments on FDA Draft Guidance Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

Mar 22 2019

March 21, 2019

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BIO Submits Comments Re: Medicare CY 2020 Part D Draft Call Letter

Mar 20 2019
BIO supports CMS’ 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 is an outdated approach that presents risks for vulnerable beneficiaries and should be re-evaluated; Coinsurance 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; 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; CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy; CMS should mitigate the impact of the increase in the out-of-pocket (OOP) threshold for CY 2020; MA plans should have the flexibility to determine what constitutes a chronic condition for purposes of providing special supplemental benefits for the chronically ill; Additional flexibility in design of maximum OOP costs should be considered to assist beneficiaries; Drug tier labels should accurately reflect the tier’s composition; Inclusion of additional measures in the Star Ratings are critical to accurate assessment of patient care and quality; Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA and Part D plans.

BIO Submits Comments re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule

Mar 20 2019
On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy changes that erode the value of the Medicare benefit for seniors, placing patient access at risk. This Proposed Rule is yet another in a series of proposals that prioritize cost containment policies over patient healthcare needs. BIO respectfully requests that the Agency and Administration instead focus on holistic solutions that balance the financial sustainability of the Medicare program, while addressing patient out-of-pocket cost and access to appropriate treatment. Our concerns, detailed further in the balance of this letter, focus on the following: I. CMS should not allow plans to restrict access in the Medicare Part D six protected classes, as plans already have flexibility to manage these drugs in a clinically appropriate manner. II. CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy for their Part B drugs. III. CMS should not move forward with the inclusion of drug pricing information in the explanation of benefits, and instead focus on the updates to e-Prescribing standard to appropriately share cost information. IV. CMS must continue to work to ensure that patients see the benefit of negotiated prices reflected in their out-of-pocket (OOP) costs. V. CMS should move forward with the proposed requirements prohibiting gag clauses.

Biomarkers: BIO Submits Comments on FDA Draft Guidance Biomarker Qualification: Evidentiary Framework

Feb 14 2019

February 11, 2019

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RWE: BIO Submits Comments on FDA Framework for a Real-World Evidence Program

Feb 8 2019

February 5, 2019

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BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies

Jan 17 2019

BIO urges the Administration to fully assess the potential impact of export controls on biotechnologies on “the impact on the economy of the United States” and on the sustainability of the U.S....