OPDP Enforcement Update on Letters Issued November 2012-March 2013

By Julie Tibbets posted 16-May-2013 18:01


In case you missed today’s Office of Prescription Drug Promotion (OPDP) webinar, OPDP did not give an opening presentation today and, instead, jumped right into the Questions & Answers segment of the webinar.  Overall, OPDP did not offer any insight into its reduction in letters it is issuing nor did it provide any information on timing of future guidance releases.  FDA mentioned that preapproval promotion seems to be an issue arising more and more.  This was interesting to note, particularly since a recent late April untitled letter to CBA Research, Inc. for promotion of an investigational new drug was posted on FDA's website by OPDP only to be removed from the website shortly thereafter without explanation.  Perhaps FDA will address this at its next webinar which will cover the April 2013 time frame. 

Following is an overview of OPDP’s responses to public and industry questions on its enforcement letters issued from November 2012 – March 2013:

  1. Pataday – the piece made on unsubstantiated efficacy claims on treating allergy eye symptoms; can you clarify how OPDP concluded that claims were unsubstantiated efficacy claims. FDA said that although there were no direct claims in the piece saying that the product is effective in treating allergy eye symptoms, there were numerous statements about allergy symptoms in the piece that implied a claim of effectiveness.


  2. Patanase – the untitled letter stated it was misleading to imply it was effective for nasal congestion because the approval was based on a composite score/measure. Can companies discuss components of a composite score? FDA said yes but that companies should not suggest that the product is effective for those individual symptoms.


  3. How does OPDP decide to make a letter an untitled vs. warning letter. OPDP said it is based on the nature of the violations, impact on public health, need for corrective action, etc.


  4. Cysview – This piece included the risk of anaphylaxis as a postmarketing event and the PI includes it that way as well. Can you provide more information on how the anaphylaxis should have been presented? OPDP said that it’s in the warning/precaution section of the PI but that the severity of the risk was not conveyed appropriately in the material and was minimized by the presentation and qualifying statements.


  5. Looking forward, does OPDP have particular areas of concern with trends in drug promotion – e.g., are you seeing more violations in terms of overstating efficacy and understating risk? FDA said it does not see any particular trends at this time but they do see overstatement of efficacy, minimization/omission of risk, and unsubstantiated claims pretty regularly.


  6. Crofelemer – Why can’t the company discuss the investigational uses for its drug? FDA said it has had a number of letters recently for preapproval promotion. FDA said that companies can do this but it has to be in an appropriate matter; companies cannot imply safety/efficacy for unapproved uses. Here, FDA was also particularly concerned about the public health impact of claims being made relative to use in children.


  7. Pataday – The promotional material made claims about itch based on a post hoc, unpublished study. FDA said that the study cited for the zero itch claim was a post hoc study and that post hoc studies are not considered substantial evidence (you need two adequate and well-controlled trials). FDA also said that the study does not necessarily need to be published to support efficacy claims; however, OPDP said that the study needs to be readily available if FDA requests to see it.


  8. Are there any tips FDA can provide regarding how companies can avoid getting an untitled/warning letter. FDA said companies should review materials internally and review enforcement letters posted on FDA’s website. FDA also said that companies should utilize the advisory comment process.


  9. Patanase - The untitled letter cited promotion of a “30 minute” claim although the origin of the “30 minute” claim is in PI. FDA said that the underlying data to support 30 minutes was in artificial environmental exposure units; the piece should have disclosed additional context regarding the artificial environmental nature of the studies; also FDA said that in real-world, randomized studies, the onset of relief was seen in 1 day of dosing (i.e., much longer than 30 minutes).


  10. Natroba – The letter said it should have noted the indicated use of Natroba in the context of an overall lice management program, etc. from the product label. Why was this objection included in letter? OPDP said that when approving the product FDA thought it was important to include this additional context/information in the indication section of product labeling – as such, it is a material fact that should be disclosed in promotion.


  11. Cysview - Imagery in piece illustrated and statements communicated in consumer friendly terms that pinkish urine can follow the procedure and alerted patients to watch for this. Why was this not an effective consumer friendly way to communicate the risk of hematuria? OPDP said that patients may interpret pinkish urine as a byproduct of the cystoscopy procedure. H ere, the concern was not whether “pinkish” was consumer friendly; in this case, blood in the urine would be a more accurate consumer friendly description.


  12. How does OPDP determine whether or not an enforcement letter is warranted? OPDP takes a risk-based enforcement approach centered on public health.


  13. What tips/techniques should be used for incorporating risk information in news media? OPDP said that its risk presentation guidance should be a starting point.


  14. Will OPDP be issuing specific guidance on how companies can properly promote on FaceBook and Twitter? OPDP said it will be issuing additional guidances; however, they will not be specific to mediums like FaceBook/Twitter but will be more general since FDA does not want its documents to become outdated when these social media mediums change or new ones are introduced.


  15. What is the reason for slow issuance of guidance? OPDP said guidance development can take a long time and that Good Guidance Practices are laid out in the regulations. Once FDA starts writing guidances, they go through extensive review. FDA also has to weigh the burden of any guidance they issue. OPDP said it hopes to get more out in the future.


  16. How do enforcement letters originate? OPDP said from its review of 2253s as well as conference surveillance and complaints both through competitors and the Bad Ad Program.


  17. In light of the Caronia decision, will OPDP significantly change its enforcement of the provisions of the FDCA? OPDP said that no significant changes will be made in light of the Caronia decision. This is because of the Court’s acknowledgment that the First Amendment does not restrict the enforcement of promoting a use that is false/misleading under its FDA’s misbranding authorities.


  18. Why does it take so long for OPDP to issue letters? OPDP said that its letters go through several layers of review prior to being issued.

Without further questions, the webinar adjourned.  

Julie Tibbets is a partner in the Food, Drug & Device/FDA Practice of Alston & Bird LLP where she focuses her practice on advising manufacturers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related matters and interactions. This publication is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.  Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.