Regulatory Brief

 Food and Drug Administration Transparency Task Force


Formal title: Docket Number [FDA-2009-N-0247] Food and Drug Administration Transparency Task Force; Public Meeting; Request for Comments

Notice of public meeting; request for comments

Brief Description:

On January 21, 2009, President Obama issued a memorandum to the heads of executive and agencies on transparency and openness. The memorandum expressed the Administration's commitment to "an unprecedented level of openness in Government". In response to the Administration's commitment to promote transparency, the Food and Drug Administration (FDA) formed an internal Task Force to consider how to make the FDA and its processes more transparent to the public. Based on comments received to date, the FDA has announced a second public meeting to discuss issues related to transparency within the agency. The second meeting will address three specific issues related to transparency in the agency: (1) Emerging safety issues concerning the FDA products, (2) Product applications that are abandoned or withdrawn by the applicant before approval, and (3) Agency decisions about pending product applications. The task force will discuss how this information should be conveyed to the public to allow for transparency so that it is useful and does not cause unfounded or unnecessary concern about an FDA product. The Task Force will also discuss what mechanisms (e.g., Internet, mass media, cell phones, direct outreach to health professional and patient organizations) the FDA should use to effectively communicate with target audiences in a timely manner.

AVMA Response:

The AVMA applauds the FDA for its goal of establishing improved transparency, which will undoubtedly facilitate greater communication and collaboration between it and its stakeholders. The AVMA offers the following comments about considerations and principles the FDA should assess in regarding its communication to the public. In accordance with the request of the FDA for its second task force meeting, the AVMA addressed the three specific "issues of discussion" the agency established as above.

1)  Emerging safety issues concerning FDA-regulated products

  • AVMA encourages continued development and strengthening of adverse event reporting
  • AVMA respectfully requests at least a brief discretionary warning about developing issues relevant to animal health and veterinary medicine.
  • AVMA has concerns about the FDA's lack of transparency when it comes to follow-up investigations
  • FDA should inform stakeholders of noticed trends and any thresholds for regulatory action early so that those involved may address the issue.

2)  Product applications that are abandoned or withdrawn by the applicant before approval

  • AVMA is not seeking proprietary information, rather it is interested in information sharing about applications withdrawn or abandoned for reasons that could potentially reduce pain and suffering by animal subjects.

3)  Agency Decisions about pending product application

  • AVMA encourages the FDA to focus its efforts on sharing information relative to regulatory issues such as drug approval, Center for Veterinary Medicine functions, and implementation of safety oversight for FDA products.

Full AVMA Response:

View AVMA's response to FDA (PDF)

View Federal Register document (PDF)

Status:

The AVMA responded on November 4, 2009.