The FDA’s Transparency Task Force has proposed that the agency publicly release refuse-to-file and complete response letters at the time they are sent to drug sponsors. This proposal, as well as others intended to improve transparency, was described in a New England Journal of Medicine Perspective article published on 5/19. This coincides with the interesting trend we’ve noted recently, of the FDA disclosing drug approvals before companies made their own announcements. In the last few months, we’ve spotted at least three times when this occurred.

FDA is very selective about which products it announces via press release as cleared or approved. Generally, this includes products that address significant public health issues, the first drugs developed for diseases with unmet needs, and first-in-class products for diseases that impact large populations. Certainly any company would welcome FDA as their public relations partner to increase visibility of their news. It is likely the agency and company have different objectives; therefore their communications strategies will differ. As part of its initiative, the Transparency Task Force said it will draft a policy that outlines FDA’s media process, which would hopefully take some of the guesswork out of the disclosure process.

For these announcements to be successful, and to meet full disclosure for the public companies, advance planning and open communications about PR with the agency are critical. The company communications director should proactively reach-out to the FDA’s office of public affairs (they won’t reach-out to you) to align communications strategies. Scenario planning is essential for the company to be prepared to pull the trigger on a timely announcement.

If FDA adopts the proposal to simultaneously disclose to the public and drug sponsor issuance of complete response letters, advance preparation and rapid response become critical. As a company’s PDUFA deadline approaches, creating message platforms for the most likely outcomes lays the groundwork for successful internal and external communications. If FDA runs with the news first, the company can quickly spring into action.

FDA is asking for comments on the transparency proposals for 60 days. Check-out FDA’s blog and access links to comment on agency proposals at regulations.gov.

Pam Lord is a senior vice president at Canale Communications and can be reached at pam@canalecomm.com.