A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").

Before I get to the "loophole," here's a summary of the guidance.

Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.

Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA

Regarding the 45-Day Review Period, FDA says:

"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."

That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.

What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.

"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review."

After writing this, I had short Twitter conversation with Alexander Gaffney (@AlecGaffney), health wonk and writer of news for @RAPSorg & Regulatory Focus. Regarding FDA's requirement to review videos and not just storyboards, Alec said the guidance would likely cuts down on "poor marketing" spending, which I interpreted to mean "pushing the envelope" spending. In the past, pharma marketers could submit a storyboard (cheap) and run the ad without waiting for comments from the FDA. The ad could push the regulatory envelope and run its course on TV before the FDA could issue a warning letter. I commented on this previously. Read "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"

The "Loophole"
FDA does not define what exactly it means by "dissemination." Perhaps it has defined this term elsewhere in it regulatory archives, but I assume in this case it means airing the ad on mass market TV. Does that include uploading the video to YouTube? A drug company could upload a video of a pre-approved ad to YouTube at the same time that it submits the video to FDA for "pre-dissemination" review. The video can then be embedded in the drug.com website or promoted via Twitter.

The bright line between TV and online video is getting more blurry every day. I currently am able to watch Youtube videos on my TV via Apple TV. Of course, it is not the same as regular TV ads that I can skip over thanks to my new cable box that allows me to record programs and play them back later. And I may be the only person that would actively search out drug TV ads published on YouTube!

Would a pharma company want to do this? Maybe, if it does not violate the "letter" of the law; ie, is not classified as "dissemination." That would let the company off the hook for violating the law, but FDA could still cite the YouTube version as violative (ie, as it does right now). A violative YouTube version of the video could result in an FDA warning letter, which probably would be issued months after the ad was first uploaded.

Just my thoughts and a comment that I think the FDA should consider when developing its FINAL guidance.