Testimony and Public Comments

PhRMA Testimony and Public Comments

Read public addresses and testimony from PhRMA regarding key issues in the biopharmaceutical industry. Click on the links below to read. 

Characterizing and Communicating Uncertainty in the Assessments of Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop (April 16, 2014)

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Food and Drug Administration’s request for comments on day 2 of the workshop, “Characterizing and Communicating Uncertainty in the Assessments of Benefits and Risks in Drug Regulatory Decision-Making,” that was convened by the Institute of Medicine (IOM) on May 12, 2014 in fulfillment of one of FDA’s PDUFA V commitments. Read more.


PhRMA Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Pathway (May 27, 2014)

The Pharmaceutical Research and Manufacturers of America (PhRMA) submits these comments in response to the Federal Register notice entitled “Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Pathway” (the draft guidance) issued by the U.S. Food and Drug Administration (FDA). Read more. 


PhRMA Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format (May 7, 2014)

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act. Read more. 


PhRMA Comments for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses (May 1, 2014)

The Draft Guidance revises FDA‘s 2009 final guidance titled Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (2009 Guidance). Read more. 


PhRMA Draft FDA Guidance Comments (April 11, 2014)

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Food and Drug Administration‘s (FDA) Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. Read more. 


PhRMA Innovation Act Letter (November 13, 21013) 

The Pharmaceutical Research and Manufacturers (PhRMA) commends the House Judiciary Committee for considering legislation to curb abusive patient litigation. We appreicate the opportunity to work with you toward this goal. Read more. 


Statement of Jeffrey Francer Before the Committee on Strategies for Responsible Sharing of Clinical Trial Data (October 23, 2013) 

The Pharmaceutical Research and Manufacturers (PhRMA) and its members are committed to enhancing responsible sharing of clinical trial data produced by biopharmaceutical companies and other research sponsors, and we appreciate the opportunity to provide testimony to the Committee on Stragies for Responsible Sharing of Clinical Trial Data (the Committee). Read more. 


Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability; 78 Fed. Reg. 38349 (June 26, 2013)

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the issuance by the Food and Drug Administration (FDA) of a request for comments in its Federal Register Notice entitled “Draft Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics; Availability” (hereinafter, “Draft Guidance on Expedited Programs”) Read more. 


New Approaches to Antibacterial Drug Development; Request for Comments, 78 Fed. Reg. 105, 32669 (May 31, 2013)

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Food and Drug Administration’s (FDA) request for comments on priorities for the development and implementation of solutions to the challenges of antibacterial drug development. PhRMA is a voluntary, nonprofit association that represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Read more. 


Testimony of Richard I. Smith, Executive Vice President, Policy and Research, Before the U.S. Special Committee on Aging

Chairman Nelson, Ranking Member Collins, and Members of the Committee, thank you for inviting me to testify on the Medicare prescription drug program, also known as Part D. Read more. 


PhRMA Comments on Draft PDUFA V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making

The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to submit these comments in response to the Food and Drug Administration’s (FDA) request for comments on its Draft PDUFA V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making dated February 2013. Read more.

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