The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing what it considered to be a false and misleading professional detail ad. The promotion for a prescription pain medication, an opioid agonist, omitted risk association and failed to include the full FDA-approved indication. The devil was in the details and, well, those details were absent.

AGG Observations 

  1. OPDP issued a Warning Letter. There is no indication that the agency previously raised concerns about the product promotion. OPDP is not required to first issue a Notice of Violation or Untitled Letter. 
  2. OPDP sent the Warning Letter because of, among other reasons, the lack of any information for the Boxed Warning product, and the truncating of the fully-approved indication, including the limitations of use. The product’s opioid’s status, in addition to the omission of material facts, presented a public health concern. 
  3. We have many pharmaceutical clients that market products with limitations of use in the indication. Limitations of use are part of the indication, and shortening the indication is a failure to provide complete information. Furthermore, the limitations of use, by definition, narrow the product’s use, frequently to note which patients should or should not use the drug (e.g., where alternative treatments are inadequate). So, failing to provide the full indication, which might include limitations of use, not only misleads a consumer to believe the use is broader than it is, but may also present safety risks by not disclosing the limitations and the product’s potentially dangerous use for certain patients. Therefore, it is essential that limitations of use be provided in the indication section of any marketing material. 
  4. While this should be evident, if a company provides statements about a product’s safety or efficacy, it must provide fair balance, such as risk information. In the Warning Letter at issue, OPDP said the company offered no risk information (which included serious and potentially fatal risks). This alone is unlawful. Add that the product contained a Boxed Warning (and was an opioid product), and the detail aid was a high-risk enforcement target for agency action. 
  5. In this case, OPDP issued the Warning Letter to the new drug application holder and copied the licensing partner. While the licensing partner might have been truly at fault for the messaging, the applicant was the addressee. The NDA holder is ultimately responsible for compliance. While parties may agree, through contract, to enter into a co-promotion or licensing arrangement, the agency looks to the NDA holder and, thus, that party must ensure that materials disseminated about its product are compliant. 
  6. As we see with many Warning Letters, OPDP required the company, as part of its response to provide:
    a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated
    (Emphasis added.)

  7. We have noted in past Bulletins and webinars that FDA has been hesitant to issue enforcement letters concerning off-label promotion, in light of past lawsuits and ever-evolving discussion. However, as we also caution, the agency will continue to take action when it sees violative promotion and, in particular, if the unlawful messaging presents public health risks. 
  8. Remember, providing FDA-required information is not optional; it is the law. Safety information is not merely nice-to-have messaging, and the details of promotional materials matter to FDA.