This summer, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.” The FDA-sponsored educational outreach effort is being administered by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research.
Last month, Arnie Friede, former Food and Drug Administration (FDA) Associate Chief Counsel, and former Senior Corporate Counsel for Pfizer, Inc., gave a presentation regarding the Bad Ad Program, and how companies need to be ready for enforcement.
During his presentation, he explained that DDMAC began exhibiting at major medical conferences last May to educate prescribers. He noted that DDMAC essentially was enlisting prescribers to recognize and report possible advertising violations. In his opinion, this amounted to FDA deputizing doctors to serve as FDA advertising investigators in the field at the point of interaction between detailer and doctor (i.e. in the office, at medical meetings, at speaker presentations). In other words, FDA was turning to doctors as unpaid informants.
Friede explained that the Bad Ad Program objective was designed by the FDA to educate healthcare providers about their role in helping FDA insure that prescription drug advertising and promotion is truthful and not misleading (i.e. doctors to help FDA police the advertising marketplace). The program also is aimed at providing healthcare providers (HCPs) with an easy way to report to FDA what they think are violations, especially because complaints can be reported anonymously. To report such violations, FDA is using this program to seek documentation from doctors to help with enforcement. The more “evidence” doctors provide, the easier it will make FDA’s job.
With respect to regulations, Friede explained that the Bad Ad Program augments FDA’s traditional 2253 “Monitoring” activities and enforcement actions based on competitor and other complaints. Specifically, he noted that the program has the effect of scaring all pharmaceutical company field activities, such as representative visits, promotion events, medical education, and so on. He also acknowledged that because “off-label” claims made orally by sales representatives are the most difficult part of cases, FDA is using this program to go right to the source to help bolster its enforcement capabilities to prove what actually was said.
In other words, the program seems primarily intended to “get at” these otherwise undocumented one-on-one encounters because detailers will not know if doctor is or is not “friendly” and will or will not report any violations. The problem this creates is that FDA is trying to exploit the skepticism that many in medical profession already have about pharmaceutical sales representatives. This could lead to a risk of over-reporting.
So then, what happens to trust? How do company/sales personnel protect themselves against risk of inaccurate reporting?
The former FDA Associate Chief Counsel explained that what happens is that communications become even more “scripted and the spontaneity of encounters and healthy give and take with doctors is significantly impacted. It also leads to further erosion of professionalism of sales personnel. It also leaves a number of questions unanswered, such as the chilling effect the Bad Ad Program will have on an otherwise already chilled relationships between detailer and doctor. He also noted the concern about how this program will impact FDA’s recognition, particularly under REMS program, that the sales force serves an important, safety-related informational function.
Consequently, he then discussed how companies will have to adopt new practices to comply with the program and to protect themselves and their sales personnel given the potential that each doctor may consider him/her self to be an FDA field investigator. One possibility is that sales personnel will have to prepare detailed “minutes” of what took place and what was said in each detailer/doctor encounter. What’s next, tape recording such interactions? These new practices will mean companies will have to bolster already robust compliance training programs, particularly for companies that have existing CIAs, State AG settlement agreements, and other compliance obligations.
He also focused on specific trends in DDMAC enforcement, and the areas they are targeting:
– Comparisons of unbranded versus branded;
– Pre-approval promotion;
– Medical-to-medical communications;
– Critical examination of claims for existence or not of “substantial evidence” by focusing on the rigor of studies/integrity of statistical analysis.
– Omission/minimization of risk information; and
– Broadening the indication/off-label promotion.
Eventually, what this program amounts to is little to no FDA resource expenditure in identifying potential violations under the Bad Ad Program. Conceptually, this fits within DDMAC’s agenda because it sends a powerful message to industry that advertising and promotion compliance is a key FDA priority. Accordingly, Friede explained that the risks associated with this program include:
– Getting a warning letter;
– Violation of an existing CIA or State AG settlement;
– Consumer fraud/product liability class action litigation;
– FDA judicial enforcement action, particularly for repeat offenders; and
– The possibility of paying fines to the FDA and other restrictions.
In closing, he explained that although FDA has not yet initiated any such actions, they may be coming, and that industry should begin making changes to address this program.