When Congress passed the Federal Food, Drug, and Cosmetic Act in 1938, granting the US Food and Drug Administration (FDA) oversight authority over prescription drugs, today's complex communications environment-with 24/7 news, social media, online and traditional advertising, and any number of messages competing for consumers' limited attention-was scarcely imaginable. Yet FDA is still charged with essentially the same job in overseeing drug promotion as it was then.
The mission of FDA's Office of Prescription Drug Promotion (OPDP, formerly the Division of Drug Marketing, Advertising and Communications or DDMAC) is "To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers."
If you are responsible the for marketing, communication and promotion of prescription drug products marketed in the US, you have to know everything you can about how FDA officials are likely to evaluate your company's or client's promotional activities. The complexity of both the communications and the products makes this no easy task.
RAPS has published FDA Requirements for Prescription Drug Promotion by John Driscoll, a consultant specializing in compliance with FDA regulation of drug promotion. Regulatory Focus recently had an opportunity to ask Driscoll about the book and its subject matter, including common compliance issues, best practices, gray areas and the challenge of drug promotion online and on social media.
Regulatory Focus: What are some of the most common pitfalls for companies advertising and promoting prescription drugs?
John Driscoll: If you look at warning and untitled letters issued by FDA's OPDP, the most commonly cited violation, year after year, is the omission or minimization of risk information (i.e., violation of the "fair balance" requirement). OPDP's focus on ensuring the safe use of prescription drugs is expected, given FDA's broad mandate to protect the public health. Since the issuance of FDA's draft guidance on the presentation of risk information in 2009, many companies have enhanced their approaches to meeting the fair balance requirement (a fact noted by OPDP itself in public meetings). Nevertheless, because of FDA's ongoing focus on safety, ensuring promotional materials meet OPDP's expectations in this area is still one of the most important ways for a company to mitigate the potential for enforcement action.
However, this does not mean that a robust approach to the presentation of risk information will fully mitigate the potential of enforcement action. OPDP still regularly cites materials for many other kinds of violations. For example, in recent years, several untitled letters have been issued solely for violations of the "substantial evidence" requirement for product claims.
RF: In what areas of promotion are FDA's rules most clearly defined, and least clearly defined?
JD: I structured the book to progress in a stepwise fashion from the basic, most "black-and-white" FDA requirements to the "gray" topics for which there is not specific guidance. The black-and-white requirements are those which are pretty clearly defined by FDA in the form of regulation or guidance. Although many in the industry would consider the grayest area at the moment to be promotion on the Internet, I do believe interpreting FDA's requirements for product claims can also be an area of much debate, especially given the different approaches taken by FDA's medical review divisions across different therapeutic areas.
Even in the gray areas, a close look of OPDP's enforcement letters reveals patterns that can help companies navigate these issues. I have included numerous enforcement letter examples in the book, which I believe differentiate it from other available resources in this field.
RF: There has been a lot written about FDA's lack of guidance on social media promotion. Are there general rules of thumb that drug companies should follow when it comes to social media?
JD: There are a host of regulatory issues associated with social media promotion, primarily due to the real-time nature of the interactions. However, I do think the lack of clarity on a few specific social media issues has obscured the fact that there are several areas relating to social media for which some direction from FDA does exist, either in the form of guidance documents or enforcement letters that indicate a fairly clear approach being taken by the agency. The last chapter of the book covers these in detail.
RF: Are there any examples of Internet or social media promotions that you would point to as particularly good practice?
JD: In the absence of specific guidance from FDA, it's difficult to definitively state what is or is not a best practice for the Internet and social media. Nevertheless, there are many similar approaches being taken by multiple pharmaceutical companies. As a regulatory professional assessing any Internet or social media promotional activity containing novel regulatory issues, I would always recommend benchmarking, either by asking the vendor for examples of other pharmaceutical companies using their service or by searching on your own.
That said, there is almost always more than one way to resolve a particular regulatory concern. The sponsored link letters issued by OPDP to 14 companies in March 2009 are a good reminder of the importance of sticking to basic regulatory principles and not necessarily always following what others are doing.
RF: Do you expect more explicit social media guidelines from FDA anytime soon? What about over the long term?
JD: With the passage of the Food and Drug Administration Safety and Innovation Act in July 2012, Congress mandated FDA to issue guidance on Internet promotion of medical products (including social media) by July 2014. At this point, OPDP has stated publicly that it intends to meet this deadline and I'm not aware of any information to contradict those statements. Nevertheless, the agency is committed to following its established practices for the development of sound guidance documents and that process does take time. FDA is especially concerned with developing guidance that will remain relevant in the ever-changing landscape of social media technology.
RF: What do you expect readers of the book to learn?
JD: The book is really intended both for those who are new to the field as well as experienced regulatory professionals.
For those with only limited experience or those who are involved in other related areas of the industry (e.g., marketing, medical affairs), I think the book can serve as a comprehensive curriculum for learning FDA's requirements for prescription drug promotion. The book's detailed referencing to all the relevant FDA communications on a topic, including numerous related OPDP enforcement letters, provides lots of additional reading for those seeking even greater depth on specific topics.
For established regulatory affairs professionals, the book is primarily intended to serve as a go-to reference for all the publicly available information on these topics. This is an enormously complex area and there are always nuances that even the most experienced professionals will need to look up from time to time. I hope the organization of this book will help my colleagues quickly get their hands on the information they need to best advise their organizations.
RF: What other important points would you stress to pharmaceutical marketers?
JD: Without a doubt, a better understanding of FDA's expectations for the promotion of prescription drugs will facilitate and expedite the internal cross-functional review and approval of promotional materials within a company. Importantly, though, greater understanding of FDA's requirements can also have profound implications for the strategic development of a brand. For example, as I discuss in the book, knowledge of the FDA expectations for different kinds of new claims is critical to the successful planning of a product's commercial lifecycle.
While the primary role of a regulatory affairs professional in this field is to ensure marketers keep within the bounds, I believe strongly that we have to be doing so in a creative, collaborative way, so that the company as a whole is always working smarter within those bounds. Better understanding of the other sides of the business should lead to better promotion and therefore better outcomes for the users of our products.
FDA Requirements for Prescription Drug Promotion is available from the RAPS Store both in print and as an e-book for $44.95 for RAPS members or $54.95, plus shipping, for nonmembers.