April 7, 2017
FDA PRA Staff, Office of Operations
Food and Drug Administration
Three White Flint North 10A63
11601 Landsdown St.
North Bethesda, MD 20852
Re: Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates to Serve on FDA's Advisory Committees (Docket No. FDA-2017-N-0366)
Dear Sir or Madam,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) related to its open docket regarding "Agency Information Collection Activities: Proposed Collection; Comment Request; Collection of Nominations for Candidates to Serve on FDA's Advisory Committees" published in the Federal Register on February 6, 2017. Representing over 100,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation's health through food and nutrition and to advancing the public health through sensible measures to ensure proper scientific integrity in all federal decision-making entities.
The Academy strongly supports the proposed changes to the FDA committee member selection process to ensure transparency. Our members look forward to engaging with and serving on relevant committees and given their expertise in matters important to the Academy.
A. Academy of Nutrition and Dietetics' Commitment to Scientific Integrity
The Academy recognizes that maintaining objectivity of scientific endeavors is the cornerstone of the evidentiary quality upon which recommendations and guidelines should be based. The trust of the public and other stakeholders is dependent on the confidence in the integrity of processes of scientific discovery, review, data aggregation and publication. To that end, the Academy published its principles of scientific integrity "to ensure that scientific activities are funded, conducted, and disseminated in an ethical, credible, and transparent way."2
B. Ensuring Transparency in the Committee Member Selection Process
The Academy supports "the FDA's goal of ensuring transparency regarding the qualifications of individuals selected to serve on FDA advisory committees." In particular, publishing the entire CV of new members without redaction will increase public confidence that the review and selection process has been conducted thoroughly and objectively, without regard to politics or relationships with third parties. Extending such policies across all FDA advisory committees further supports maintaining science as the primary determinant in policy making.
In fact, existing and prior relationships do not necessarily preclude high-quality evidence or compromise the objectivity of the decision-makers as long as such relationships are disclosed and made fully transparent through a standardized reporting method from the earliest stages of the process. Relationships requiring disclosure include not only personal or financial relationships, but also familial and intellectual conflicts. Additionally, we must be assured committee members' relationships do not determine or control content, direction, or outcomes of reviews, publications, deliberations, reports, positions, or online media content.
The Academy appreciates the opportunity to comment on the draft report related to the Collection of Nominations for Candidates to Serve on FDA's Advisory Committees, and we look forward to collaborations at the intersection of public health and nutrition, both by encouraging research according to principles of scientific integrity and by ensuring our members are engaged on these issues. Please contact either Jeanne Blankenship at 312/899-1730 or by email at email@example.com or Pepin Tuma at 202/775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Tappenden, KA. A unifying vision for scientific decision making: The Academy of Nutrition and Dietetics' scientific integrity principles. J Acad Nutr Diet. 2015;115:1486-1490.