DRUG INFORMATION IN MEETING PROGRAM BOOKS IS SUBJECT TO FDA REGULATION
DRUG INFORMATION IN MEETING PROGRAM BOOKS IS SUBJECT TO FDA REGULATION as advertising, Division of Drug Marketing, Advertising and Communications Acting Director Janet Rose said in a May 20 letter to all drug companies. "We remind the pharmaceutical industry that all entries in any commercial listings of exhibitors that mention prescription drug products are subject to regulation as advertising," Rose stated. The letter is one in a series from DDMAC to industry providing updates on policies and procedures for prescription drug advertising and promotion. Program books for scientific meetings often contain a section on commercia exhibitors that includes descriptive statements or paragraphs that mention prescription drugs, Rose noted. The FDAer emphasized that "any presentation of product names that is accompanied by information about indications or usage will be viewed as a full product advertisement [and] such presentations are not subject to the reminder advertising exemptions, and therefore must comply with the full disclosure requirements of 21 CFR S 202.1(e)(1)." Several examples of descriptive statements that would or would not require full product disclosure are included in the letter. Under the reminder exemption, it is "permissible" to say: "XYZ Pharmaceuticals Inc. invites you to visit our booth, where our representatives will be happy to discuss Drug Tradename A, Drug Tradename B, and Drug Tradename C." However, full disclosure would be required for the following statement: "XYZ Pharmaceutical Inc. invites you to visit our booth, where our representatives will be happy to discuss Drug Tradename D, our new drug for Disease Q, as well as our entire line of products for Disease R, including Drug Tradename E." Firms also are reminded in the letter that "announcements of products that are 'coming soon' will also be regulated according to current DDMAC policy regarding 'pre-approval' promotion." At the May 19 session of the Food and Drug Law Institute's Pharmaceutical Update conference, Rose made her inaugural speech as acting head of DDMAC, discussing the division's philosophy of drug advertising surveillance and enforcement. First, she said, "it is important that everyone clearly understand that DDMAC is committed to aggressively enforcing [the] law at all times." However, she noted, "I also want you to know... that we do not see our job as playing 'gotcha,' despite some belief...otherwise." Asserting that FDA has "taken steps through the years to ensure that DDMAC [regulates] fairly and as consistently as possible," the FDAer added that she is "going to make that one of the mos important things that I do while I'm there, to try to increase the consistency with which we operate." Rose, who before joining FDA was a district sales manager for Mead Johnson, was appointed in early March as the division's acting director for a 120-day detail ("The Pink Sheet" March 15, T&G-5). DDMAC's current philosophy is "to educate the industry, when possible, as to the division's interpretation of the regulations as they apply to current [drug] promotion," Rose said. "In this manner, industry can prepare materials in keeping with those regulations and know that when they do prepare those materials, they'll be acceptable and not violative." Rose added that she would like the division to send out more advisory letters to industry, such as those covering specific therapeutic classes of drugs, "as an educational service to you all, to help level the playing field." This approach "translates into safer promotional messages and less monetar waste as a result of violative materials," Rose told FDLI. "In addition, the public wins by having better informed physicians and DDMAC wins by better utilization of resources." Rose said she hopes that a "net result" of this "proactive philosophy" will be "to lower the cost of healthcare".
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth