Pharmaceutical Executive
At the Division of Drug Marketing, Advertising, and Communications (DDMAC), our goal is to assure that prescription drug promotion is not false or misleading, and that it presents a balanced picture of a drug's risks, as well as its benefits.
At the Division of Drug Marketing, Advertising, and Communications (DDMAC), our goal is to assure that prescription drug promotion is not false or misleading, and that it presents a balanced picture of a drug's risks, as well as its benefits.
How prescription drugs are used is a critical part of obtaining their benefits safely, so the law requires thorough disclosure of any consequences of using the drug. Promotional materials should accurately communicate the drug's indications and benefits, and communicate the most important risks in a manner reasonably comparable to the presentation of benefits.
For most prescription drugs, promotional materials do not need to be submitted to FDA before use. Rather, they are submitted at the time of their initial use. FDA's review of promotional materials therefore generally occurs after the materials have already appeared in public, and any action FDA takes will also occur after the materials have been seen publicly.
When we at FDA encounter violative promotion, we have a number of enforcement tools, including untitled letters and warning letters. Most of FDA's enforcement actions ask sponsors to stop using the violative materials, but in some cases—and in most warning letters—FDA also asks sponsors to run corrective promotional materials to remedy misimpressions created by the false or misleading materials.
Untitled letters are used for less severe violations of the Federal Food, Drug, and Cosmetic Act and regulations. Violations that might receive an untitled letter include overstating the effectiveness of the advertised product, suggesting a broader range of conditions than those for which the drug was approved, or misleading through inadequate context or lack of balancing information.
Warning letters address more severe violations, including those creating serious safety or health risks, and those involving egregious or repetitive conduct, which, if not promptly and adequately corrected, could lead to further enforcement action. Complete omission of any safety information from the body of a promotional piece is a common basis for a warning letter.
The most common violation we see is omitting or minimizing risk information, an obvious concern since communicating risks to the public is so important. Healthcare providers must weigh the risks and the benefits of drugs in deciding whether to prescribe them. And consumers need to understand the benefits and risks of drugs so they can have informed discussions with their healthcare providers. The American public, whether healthcare provider or consumer, is entitled to a balanced picture of the drug when it is promoted.
Other violative promotion includes claims that a drug is better or more effective than is stated in the approved product labeling (especially for products with relatively low efficacy), safer than demonstrated (fewer side effects, lower severity or incidence), or better or safer than other products, without substantial supporting evidence. Generally, FDA requires two adequate and well-controlled head-to-head studies.
We also see violative promotional materials that contain incomplete communication of the indication, misleading presentation of data or risk-benefit information (e.g., selective presentation of only favorable data, suggesting clinical significance where there is none, or cramming all the risk information onto the bottom of the page in very small type). Another common violation in promotional material: broadening an indication or suggesting unapproved uses. Television broadcast ads present distractions in the audio or visual portions of the ad that divert attention from the risk information.
DDMAC posts untitled letters and warning letters on the FDA/CDER Web site. This provides information to all regulated parties regarding our enforcement activities and rationale. And, we hope, it helps teach regulated parties to avoid violations cited in the letters. Reviewing our untitled letters and warning letters reveals the types of violations that we see on a regular basis.
Companies must submit the promotional material to FDA (along with form FDA-2253) at time of first use as required by the regulations. Promotional materials include sales aids, Web sites, brochures, exhibit booth panels, reprint carriers, posters, booklets, mailing pieces, bulletins, catalogs, letters, videos, and slides, as well as advertisements in published journals, magazines, periodicals, or newspapers, and advertisements broadcast on radio, television, or telephone. Failure to submit is another common violation, and it can often exacerbate other violations in the promotional material by allowing them to continue for a longer period of time.
We also provide guidance that is posted on the FDA/CDER Web site, and additional information is available on the DDMAC Web site.
Lesley R. Frank, PhD, is senior advisor regulatory counsel within the Division of Drug Marketing, Advertising, and Communications (DDMAC) in the Center for Drug Evaluation and Research (CDER) at FDA. She can be reached at frankl@cderfda.gov
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.