For nearly a year, Given Imaging’s Diagnostic Imaging System (which features a swallowable video capsule) had been covered extensively by the worldwide media. But when the Food and Drug Administration approved the device, the company was in the midst of its pre-IPO “quiet period.” Given was well aware of the value of publicity – and, in fact, wanted it – but feared jeopardizing its IPO by saying too much.
The company hired Ruder Finn for counsel about the need to exploit FDA approval of the device in the face of lawyers’ demands to remain silent during the “quiet period.” Striking a compromise with the lawyers, RF devised a launch strategy that resulted in major print, wire and broadcast coverage without provoking the ire of the SEC.
Objectives: In pitching the Given story to the financial and trade media, Ruder Finn stressed:
· The name of the capsule
· Its indication (what it was to be used for)
· Its effectiveness compared to other small-intestine imaging technologies
· Its availability for use with patients
Strategy: Create an FDA approval plan that met Given’s needs, but also satisfied legal obligations
Overcoming Legal Counsel’s Objections: Ruder Finn prepared a full-fledged media-relations plan, including embargoed notification of the Associated Press of pending FDA approval and the creation of VNR and b-roll packages for distribution to broadcast organizations
However, the lawyers shot down the initial proposal. During the ensuing discussion, RF modified its proposal to include only a bare-bones press release announcing the FDA approval and limited distribution of the release (to FDA beat reporters in Washington, DC). The lawyers agreed that this approach was within their interpretation of SEC regulations regarding communications during a quiet period.
Preparing for FDA Approval: Ruder Finn wrote the approval press release and identified reporters who traditionally cover FDA approvals. Ruder Finn also researched the timing of past FDA approvals of medical devices, as Given executives were operating under the mistaken notion that approvals, as an FDA policy, were announced late in the day on Friday to avoid roiling the financial markets.
Approval: Given received its approval letter at 4:30 p.m. on Wednesday, August 1. As soon as Ruder Finn was notified, agency executives began calling the AP, Reuters, Dow Jones, Bloomberg and network correspondents at ABC, CBS, NBC and Fox.
Ruder Finn reached the AP’s Lauran Neergaard, who was scrambling, pre-deadline, to find a Given official and physician to speak to about the approval. Ruder Finn put her in touch with Dr. Blair Lewis, the only U.S. physician with extensive experience with the technology, who answered her questions about the cost of the system and its availability.
The FDA approval of the Given Diagnostic Imaging System received extensive publicity through the nation’s newspapers and broadcast news organizations, including The New York Times, The Wall Street Journal, USA Today and The Washington Post
The following week, stories were broadcast on NBC Nightly News, ABC’s World News Tonight and CBS Evening News.
Given’s vice president of marketing acknowledged that Ruder Finn’s plan “worked perfectly.” One month later, after a review of ten investor-relations firms, Given Imaging awarded Ruder Finn the assignment of handling media relations surrounding Given’s IPO, which became the first post-9/11 IPO.