FDA "SUBPOENA" PROMO LETTERS

The inquiry letters being sent by the US Food and Drug Administration to pharmaceutical firms relating to possible advertising and promotion violations look like subpoenas, attorney James Johnstone, of the law firm Wiley, Rein & Fielding, has told a meeting of the US Food and Drug Law Institute.

The inquiry letter is based on the subpoena letters sent out by the Federal Trade Commission, reports the Pink Sheet but, goes on to note that the FDA does not have power of subpoena.

In the letter, the FDA asks companies to cooperate with the inquiry into concerns that they may be promoting a product "for use beyond its labeled indication in both printed promotional materials and in details or sales presentations to physicians." It requests that they voluntarily submit "all responsive documents in the possession, custody or control of the company," and adds that if any employee, agent, director or representative of the company is unwilling to have his or her files searched, or is unwilling to produce responsive documents, then the company should inform the agency of that person's name, address, telephone number and relationship to the company.