Regulatory Focus™ > News Articles > FDA Should Improve Science Integrity Policy and Visitor Logs Policy, Group Argues

FDA Should Improve Science Integrity Policy and Visitor Logs Policy, Group Argues

Posted 11 March 2013 | By Alexander Gaffney, RAC

A prominent science advocacy group is calling on the US Food and Drug Administration (FDA) to do a better job at explaining provisions put into place to protect the integrity of scientific data, saying agency employees likely have a difficult time understanding them in plain terms.

Background

The group, Union of Concerned Scientists (UCS), regularly comments on FDA matters; everything from scientific integrity at the agency (under pressure from industry, they say) to how FDA scientists feel about working for the agency (under-resourced and over-worked, they found) and endemic advisory committee vacancies (they know of some qualified people if FDA's interested).

Central to the themes of nearly all of UCS's reports is one question: Can employees working for an agency trust that decisions are being made with the best possible data?

FDA has come a long way in that regard, the group said in its report, but still has a long way to go.

'Specifics Missing'

"[The] principles are there but specific provisions and guidance are missing," wrote Francesca Grifo, senior scientist and science policy fellow at USC in her report, "Federal Agency Scientific Integrity Policies: A Comparative Analysis."

Grifo specifically looked at FDA's Staff Manual on Scientific Integrity (SMG 9001.1), which lays out the framework for FDA's "principles, policies and practices that relate to the preservation and promotion of scientific integrity."

UCS's annotated version of the same manual takes issue with some portions of the text, while praising others.

One positive development noted by the group was that FDA seems to be "taking strong steps toward limiting conflicts of interest on scientific advisory panels," UCS wrote, which has allowed the agency to largely escape concerns regarding the impartiality of the advice is receives from the advisory committees.

Recommendations Include Visitor Log Changes

But the same report notes various issues with the guidance, though some appear to be mostly cosmetic.

For example, page three of the annotated version notes that FDA fails to mention the FDA Amendments Act of 2007, which requires that dissenting opinions be made public in an "action package" within 30 days. In other areas, it is unclear as to whom the policy is addressing.

UCS also called on FDA to release its visitor logs "so that the public may better understand who is influencing science-based policy decisions."

"The visitor log policy should apply to political appointees, Senior Executive Service and GS-14 and GS-15 level employees," UCS added. A similar policy is already in place at the White House, and is meant to allow the public to see when lobbyists or other groups meet with agency officials.

Other Points Made

Other points made by UCS include:

  • Not explicit that policy applies to political appointees, supervisors, and contractors in addition to career employees.
  • Promises FDA written media relations policy, but this could not be found on the FDA website.
  • Requires permission from public affairs to speak to the media in an official capacity.
  • No provision allowing scientists the right to review, approve and comment publicly on the final version of any scientific document that relies on their research or identifies them as a contributor.
  • No procedure detailing how allegations of scientific misconduct will be investigated, managed and reported.
  • No data sharing and dissemination specifics. Unnecessary hurdles prevent data and research from being made public.
  • Especially important at the FDA - scientific integrity principles should pertain to scientific information submitted to the agency from interested parties.
  • Lacks specifics as to how stated principles will be enforced and upheld.
  • Less well-intentioned administrations could use Department of Health and Human Services policies to restrict scientific integrity

FDA's ranked around the middle of all US agencies in UCS's final analysis, and is seen by the group as promoting and supporting scientific integrity, but needing additional changes. Just six groups-the CDC, Interior Department, NASA, EPA, NOAA and the NSF-were seen as "actively" promoting a culture of scientific integrity.


Tags: Science

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