Comments on Periodic Review of Existing Regulations; Retrospective Review under Executive Order 13563

Jun 27 2011


Address by H.R.H. Prince Philippe of Belgium to the 2011 BIO International Convention

Jun 27 2011

BIO Testimony to the House Agriculture Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture

Jun 23 2011


BIO’s Comments on the Internal Revenue Service's (IRS) Proposed Guidance Regarding the Branded Prescription Drug Fee

Jun 15 2011
BIO’s comments reiterated concerns with widespread data issues that were expressed in BIO’s April 2011 comment letter. BIO provided suggestions to improve the transparency of the assessment process.

American Invents Act Manager's Amendment: BIO Strongly Supports

Jun 14 2011
The legislation would end the diversion of fees collected by the U.S. Patent and Trademark Office, increase the objectivity of our patent system, and increase patent quality. It is precisely these types of reforms that should receive bipartisan support, as they are good for inventors and investors, hence good for business and jobs in America.

Fee Diversion: BIO Joins Broad Coalition to Support End of Fee Diversion at PTO

Jun 13 2011
Absent a statutory mechanism to prevent future fee diversion, the existing and new responsibilities vested in the U.S. Patent and Trademark Office (PTO) will suffer, the ability of the PTO to plan long-term and build the agency our innovation economy demands will be frustrated, and the job-stifling patent application backlog will continue.

BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Jun 9 2011
BIO generally supports and agrees with FDA's statements that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the 351(k) pathway also presents unique challenges compared to existing programs.

BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA); Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017"

Jun 9 2011

BIO's Comments on the CMS Accountable Care Organizations Proposed Rule

Jun 6 2011
BIO appreciates the steps CMS has taken to minimize adverse incentives under risk-based arrangements, but believes that more must be done to ensure that beneficiaries that are treated by ACO participants have timely access to novel, innovative therapies. In the comments, BIO addresses matters such as the ACO quality measures, beneficiary protections, access to innovative new technologies and maintaining the integrity of the shared savings program.

BIO Submits "Guideline on similar biological medicinal products containing monoclonal antibodies" Comments to the European Medicines Agency (EMA)

May 31 2011
In the comments, BIO acknowledges that the guideline is useful and contributes guidance to those planning to develop biosimilar versions of existing originator monocolonal antibodies. However, since the Guideline attempts to cover a very wide and diverse group of products it has to allow for a range of circumstance and be potentially very flexible.