How will FDA enforce new DTC rules?

Newly proposed standards for DTC advertising were designed to give drug marketers flexibility in complying, the FDA says. But as some industry observers point out, the new rules would give FDA some enforcement flexibility, too.

Current DTC regulations require side effects and other risks to be presented in a "clear, conspicuous and neutral manner," and in a way that's comparable to the presentation of efficacy info. The new guidance sets standards for just what clear, conspicuous, and neutral entail. Voice-overs will have to be easy to understand, and printed info will need to be designed for readability. No distracting images or sounds can draw attention from the risk info. And overall, the ad has to be "accurate and non-misleading," the agency proposes.

Sound flexible to you? The FDA Law Blog thinks the standards are a bit too flexible. "[T]he proposed regulations fail to clearly articulate what type of language will be clear, conspicuous, and neutral to consumers," the blog states. Who are these "consumers?" How educated are they? How can technical side-effect language be translated for them?

But even if those basic questions are answered, the real question remains: Will FDA use the new standards to be severe? "The real issue is whether DDMAC will be stricter," points out DTC Perspectives, which goes on to say, "[Y]ou can drive a truck through the possible interpretations."

Going by the Obama FDA's record so far, the agency won't use those truck-size holes to be lax on drugmakers. The number of enforcement letters has increased substantially under the new regime. Does anyone doubt that these new rules would change that? Let us know.

- get the story from Medical Marketing & Media
- check out the coverage at Pharmalot
- see the post at FDA Law Blog
- read the DTC Perspectives piece