1 / 8

Speech that FDA Generates

Speech that FDA Generates. William McConagha Office of Accountability Food and Drug Administration Risk Communication Advisory Committee February 28, 2008. Scope of FDA’s Communication. FDA communicates with stakeholders in a variety of ways through a variety of mediums.

karan
Download Presentation

Speech that FDA Generates

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Speech that FDA Generates William McConagha Office of Accountability Food and Drug Administration Risk Communication Advisory Committee February 28, 2008

  2. Scope of FDA’s Communication • FDA communicates with stakeholders in a variety of ways through a variety of mediums. • FDA’s communications cover a wide range of topics, including risk information.

  3. Scope (cont’d) • FDA uses several methods to communicate risk information to the public. • Certain forms of communication are targeted to specific audiences, such as health care professionals and the public

  4. Methods for communicating risk to the general public: • Public Health Advisories • Press releases • Partnerships/Information Networks • Patient Information Sheets • Public Service Announcements (PSAs)

  5. Methods for communicating risk to healthcare professionals • Healthcare Professional Sheets • Partnerships/Information Networks • Professional labeling for prescription products

  6. Other means of communication Sometimes FDA is also involved in the communication of risk by sponsors: • “Dear Doctor” letters • Voluntary product recalls

  7. Factors that impact FDA’s message: • Reliability of the data at issue • Plausibility of a causal relationship between product and the evidence on which the risk is based • Magnitude of the risk • Medical necessity of the product(s) at issue • Extent of exposure

  8. Factors (cont’d) • Effect on clinical practice • Disproportionate impact on particular populations • Facts versus advice (i.e., should FDA educate practitioners about an emerging risk or actually advise them not to prescribe a drug while the risk is further evaluated) • Trade secrets and confidential commercial information (CCI) • Personal privacy

More Related