The FDAAA DTC Television Ad Pre-Dissemination Review ProgramThe 45-Day Clock

Krystina Smith, Research Analyst

Of course we aren’t your lawyers and our lawyers are making us say to you that you should check all this out with your own lawyers.  Full employment for lawyers . . .

The FDAAA was signed into law in September 2007

• The Food and Drug Administration Amendments Act of 2007 (FDAAA) gives the 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 FDA may make recommendations with respect to information included in the label of the drug on:– Changes that are necessary to protect the consumer good and well-being, or that are

consistent with prescribing information for the product under review– Statements for inclusion in the advertisement to address the specific efficacy of the

drug as it relates to specific population groups, including elderly populations, children, and racial and ethnic minorities, if appropriate and if such information exists

Source: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm

The FDA has just acted on this

AUTHORITY and is now implementing a

“45-day clock”

Sponsors are required to submit TV ads for pre-dissemination review in 6 categories

Category Definition

Category 1The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug

Category 2All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use

Category 3 All TV ads for Schedule II controlled substances

Category 4The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings and 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 (ie, 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 6Any TV ad that is otherwise identified by the FDA as subject to the pre-dissemination review provision

Source: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm

Noncompliance with the FDAAA has significant consequences

• It is prohibited to disseminate a TV ad that falls within 1 of the 6 categories:– That has not been submitted for review– Before the 45-day comment period ends, without waiting for comments from the FDA– That has not incorporated the agency’s comments

• Noncompliance can result in criminal penalties, a civil monetary penalty amount, the issuance of an untitled letter, a notice of violation, warning letter, or other government enforcement action to/against the sponsor of the TV ad

Source: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm

What if the FDA does not respond within the “45 day clock”?

• If the FDA is not able to provide comments within the 45 calendar day time frame, the FDA will notify the sponsor– The FDA notification WILL include an estimation of the date on which FDA expects to

provide its comments

• The sponsor is given 2 options– Wait for FDA’s comments before disseminating the TV ad– Disseminate the TV ad without waiting for FDA’s comments

• Whichever decision the sponsor makes, the FDA should be notified• Once the 45-day review time has elapsed, there is no specific legal

consequence resulting from disseminating the TV ad– However, the sponsor is still at risk of enforcement action if the ad violates the FD&C

Act and implementing FDA regulations

Source: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm

The FDAAA pre-dissemination review program is specifically for television ads

• The FDA issued the guidance to communicate the categories of TV ads for a particular drug or group of drugs

• There is no guidance for videos uploaded to the Internet

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There may be consequences for DTC ads being placed on the Internet that are not presubmitted to FDA

• Once online, it is possible to embed the video on other websites or promote it via social media platforms, such as Twitter, which both could exacerbate any potential FDA concerns

• Although not a direct violation of the evolved guidance, the FDA can still cite the uploaded video as violative

Smart social media engagement does not need to rely on FDA “loopholes”

• The line between TV and online videos will continue to blur

• The potential of online videos is powerful and should be respected as so

• A smart and engaging social media strategy is possible for pharma companies and can be managed within FDA guidelines

• Following the spirit of the new guidelines is recommended – even when considering DTC ads for the Internet