BIO Testifies at FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Mar 2 2011
Given the significant morbidity and mortality often associated with rare and orphan diseases, the unmet medical need, the societal costs, and the challenges of conducting trials in these patient populations, BIO believes that the current regulatory environment and FDA's review processes need to be re-evaluated and modified for orphan products. The regulatory approval pathway needs to be predictable, faster, and one that more clearly balances benefit/risk for these orphan disease patients and their families. The testimony urges publication of additional guidance on orphan drug development, consideration of alternative approaches to demonstrating efficacy, the greater use of surrogate endpoints, enhancement of the FDA-Sponsor communication processes, and the understanding and acceptance of appropriate risk tolerance.

Value-based Insurance Design in Connection with Preventive Care Benefits

Mar 1 2011
On February 29, 2011 BIO commented on the design aspects of preventive care benefits in value-based insurance plans.

Biofuels and the Environment: EPA Report to Congress

Feb 28 2011
BIO says potential impacts from biofuels should inform, but not impede, realization of potential benefits from biofuels in comments on EPA Draft report, Biofuels and the Environment.

Australian Gene Patent Bill: BIO Comments to the Australian Senate Committee on Proposed Patent Amendment

Feb 25 2011
BIO believes that the proposed amendment would, if adopted, have significant unintended and adverse consequences in all sectors of biotechnology and for patients and consumers in Australia. This amendment also would fail to affect its intended purpose, which is to advance medical and scientific research and the diagnosis and cure of human illness and disease.

BIO Defending Existing Funding for Bioenergy Programs

Feb 25 2011
BIO submitted a joint letter to Senate leadership urging full funding be maintained for existing bioenergy programs at DOE and USDA in CR legislation to fund the federal government through the remainder of FY11.

BIO Comments to CMS on Draft Update of Chapter 4 of the Medicare Managed Care Manual, "Benefits and Beneficiary Protections"

Feb 24 2011
BIO submitted comments on the draft update which would potentially allow Medicare Advantage plans to restrict access to certain covered Part B drug or durable medical equipment items. BIO urged CMS not to implement the proposed change as it would deny beneficiaries access to medically necessary drugs and biologicals.

BIO Submits Comments on FDA’s Good Laboratory Practice for Nonclinical Laboratory Studies

Feb 22 2011
BIO supports FDA's initiative to revise the Good Laboratory Practice (GLP) regulations to more completely address how nonclinical studies are currently conducted, particularly in light of the fact that the regulations have not been substantially revised since the late 1970's. BIO also supports a quality systems approach to GLP to ensure continual improvement and high quality lab studies, which is embodied in the current GLP regulation. Wherever possible, we also encourage alignment with international standards and principles governing the conduct of nonclinical studies.

2011 Special 301: BIO Comments to USTR

Feb 15 2011
In comments to the U.S. Trade Representative (USTR), BIO stresses the critical importance of protecting intellectual property abroad and made recommendations about which countries to include on the Priority Watch and Watch List, which to elevate as a Priority Foreigh Country, and which countries to monitor.

BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

Feb 14 2011
BIO requests clarification on the need for "greater than additive activity"; deletion or revision of the criteria for a "compelling reason for why the agents cannot be developed individually"; discussion of co-development of existing compounds for use in combination in unapproved indications; and the inclusion of oncology drugs. BIO also recommends a case-by-case approach for early combination studies and suggests opportunities for ongoing collaboration with FDA.

Statement of Support for Montana SB218

Feb 1 2011
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of claims involving protected plants; providing an exception; providing rulemaking authority; and providing an immediate effective date."