HOST: Mary Kremzner
PHARMACIST #1: Beth Carr
PHARMACIST #2: Jaewon Hong
MARY: The Food and Drug Administration reviews advertising and promotional labels for prescription drugs to make sure the content isn’t false or misleading. What materials are regulated? How can advertising violate the law? And what are the consequences?
Welcome, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in FDA’s Division of Drug Information.
I spoke with two FDA pharmacists, Lieutenant Commander Beth Carr and Commander Jae Hong for today’s discussion.
There are many elements surrounding the marketing and advertising of a drug product. Let’s start by talking about which promotional materials the FDA regulates.
BETH: Sure. Let’s begin by making a clear distinction. The Federal Trade Commission regulates advertising for over-the-counter drug products. FDA regulates advertising for prescription drugs, which is our focus today.
For prescription drugs, there’s a range of materials subject to regulation, like TV, radio and journal ads…brochures… emails… websites
JAE: FDA often receives inquiries about whether or not prescription drug companies have to submit their promotional materials to the FDA before they appear in public. And, in most cases federal law doesn’t allow the FDA to require an advanced review. But manufacturers do have to submit all their promotional material at the time they go public.
Many drug companies voluntarily seek out FDA’s advice before their promotional materials are disseminated. They want to be proactive in assuring their promotional materials meet FDA standards.
MARY: What are some of the different ways that drug companies violate the FDA’s regulations?
JAE: Frequently cited violations include overstating a drug’s efficacy…and omitting or minimizing information about risks.
Here’s a book published by a company called Taro Pharmaceuticals. It’s about Ovide, their lotion for treatment of head lice. The book makes the representation that Ovide is indicated and is prescribed for the treatment of head lice, however, nowhere does it mention the risks associated with the drug. This is a violation that misleadingly suggests that Ovide is safer than has been demonstrated.
BETH: Other common and frequently cited violations include unsubstantiated superiority claims, and unsubstantiated claims of efficacy or safety.
Also, it is important to note that ads have to present risk and efficacy information in a similar way, with font size, bullets, white space and headlines that all meet a “fair balance” requirement.
Here’s one ad that received an untitled letter from the FDA. As you can see, the ad prominently presents efficacy claims in large, bold, and colorful font and graphics, while the risk information is relegated to the bottom of the piece and is written in an extremely small font size and in single-spaced paragraph format.
Enforcement letters sent to the drug companies are the most frequent and common type of enforcement action. These letters are posted on the FDA website.
The FDA requests that the companies stop running the ad immediately.
JAE: And if an ad poses a serious threat to public health, the FDA will ask the drug company to stop running the erroneous ad and run a new, corrective one in its place, similar to a retraction you may see for a newspaper article.
MARY: FDA has also established the Bad Ad outreach program to educate healthcare professionals about their role in stopping deceptive or misleading drug promotions. If you want to learn more about what you can do if you suspect a violation in drug advertising, please visit our website.