1. The FDAAA DTC Television Ad
Pre-Dissemination Review Program
The 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 . . .

2. 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/SignificantAmendmentstotheFDC
Act/FoodandDrugAdministrationAmendmentsActof2007/default.htm

3. The FDA has just acted on this
AUTHORITY
and is now implementing a
“45-day clock”

4. Sponsors are required to submit TV ads for pre-dissemination
review in 6 categories
Category Definition
The initial TV ad for any prescription drug or the initial TV ad for a new or expanded
Category 1
approved indication for any prescription drug
All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy
Category 2
(REMS) with elements to assure safe use
Category 3 All TV ads for Schedule II controlled substances
The first TV ad for a prescription drug following a safety labeling update that affects
Category 4 the Boxed Warning, Contraindications, or Warnings and Precautions section of its
labeling
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
Category 5
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
Any TV ad that is otherwise identified by the FDA as subject to the pre-dissemination
Category 6
review provision
Source:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDC
Act/FoodandDrugAdministrationAmendmentsActof2007/default.htm

5. 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/FederalFoodDrugandCosm
eticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm

6. 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/FederalFoodDrugandCosm
eticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm

7. 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
?

8. 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

9. 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