March 13, 2012 – Draft guidance released today by the FDA – “Guidance for Industry Direct-to-Consumer Television Advertisements” – calls for drug sponsors to submit nearly all direct-to-consumer (DTC) television ads for review 45 days prior to dissemination and specifies the documentations needed for all new advertising claims.

The draft guidance describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007. It also explains how the FDA will notify drug sponsors that an ad is subject to the program and sets out procedures sponsors need to follow in order to be in compliance with the provision.

“Maybe it’s a good thing that the longtime ‘voluntary’ pre-review system is now official, but there is no good news here for patients who want speedy access to information about new medicines,” explained John Kamp, Executive Director of the Coalition for Healthcare Communication. “This law and draft guidance in effect create a ‘45-day shot clock’ that blocks information to doctors and patients about new drugs. Moreover, there is no ‘overtime’ added to the patent period to make up for these delays,” he said.

In fact, Kamp points out that these draft procedures appear to impose a new set of mandates on drug sponsors, including the submission of background information and documentation that substantiate the claims in submitted TV ads, including annotated references that are cross-referenced to the ad’s storyboard.

Agencies and clients are urged to review this guidance carefully and submit comments directly or through the Coalition by the May 14 deadline.

Long List of Ads Subject to Requirements

According to the draft guidance, sponsors must submit TV ads for pre-dissemination review if they fit in the following categories: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; or
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre­-dissemination review provision.

Without specifically saying so, this list includes nearly all types of TV ads that drug companies would run, except for ads that are just remixes of the same basic information, with no new claims or changes.

Further, Category 5 forces sponsors that receive an enforcement letter for a TV ad to continuously submit TV ads – whether or not they include new information – for pre-dissemination review.

The draft guidance states that the FDA will notify drug sponsors of the requirement to submit their ads for review in the following ways: in letters approving future applications or supplements, in a labeling update, in an enforcement letter or “in other correspondence.” Already approved product sponsors falling into Categories 1, 2 or 3 will be informed of the requirement through Federal Register notices, the draft guidance states.

However, the agency also states that the onus is on sponsors to determine whether their ads fall into any of the six categories slated for pre-dissemination review, adding that “dissemination of a television ad without complying with [the provision] is a prohibited act” which can be enjoined and is subject to criminal penalties and potential civil monetary penalties.

Pre-dissemination Package Requirements

The pre-dissemination “review package,” to be submitted 45 days prior to

dissemination, must include:

• A cover letter that:
  • Provides the following subject line: Pre-Dissemination Review Package for a Proposed TV Ad for [Proprietary Name/Established Name (dosage form) (for drugs), or Trade name/Proper name (for biologics)] Subject to 503B of the FD&C Act Includes the NDA or STN number
  • Provides the name of the proposed TV ad
  • Lists the contents of the pre-dissemination review package and the number of copies provided of each item contained in the pre-dissemination review package
  • Provides a sponsor contact’s name, title, address, phone, fax, and email
• Annotated storyboard of the proposed TV ad to show which references support which claims
• The most current FDA-approved prescribing information (PI) and, if applicable, the FDA-approved patient labeling or Medication Guide with annotations cross-referenced to the storyboard

The guidance also states that a sponsor should include other appropriate documentation, if any of the following apply:

• Annotated references to support product claims not contained in the PI, cross-referenced to the storyboard
• Verification that a person identified in a TV ad as an actual patient or health care practitioner is an actual patient or health care practitioner and not a model or actor; and/or verification that a spokesperson who is represented as a real patient is indeed an actual patient; and/or verification that an official translation of a foreign language TV ad is accurate
• Annotated references to support disease or epidemiology information, cross-referenced to the storyboard
• A video of the TV ad in an acceptable format, if available. 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.

“Industry must speak up,” Kamp said. “The FDA must be made aware of the practical impact of these proposals, and we must give them alternatives that are consistent with the statute but that also provide doctors and patients with speedy access to information.”  Agencies and publishers interested in participating in the development of the Coalition’s comments are urged to contact Jack Angel; jeangel44@yahoo.com.