Strategic and Operational Risk Factors Involved in the Review and Approval of Promotional Materials

By: Joe Calarco, CIS Senior Manager
joecalarco@cis-partners.com

Anyone who spends most of their time in R&D lives for the euphoria a company experiences upon receiving FDA approval of a product; everyone in the company feels a sense of accomplishment. However, what many in R&D do not witness is the effort it takes to coordinate an effective and compliant promotional campaign for the product.

From the time the product became a viable candidate for FDA submission, the company’s Marketing representatives have been developing a strategy to effectively market the product. This strategy likely includes discussions on how to comply with the federal regulations involving promotions overseen by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). The following is the mission of DDMAC:

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. [1]

Based on the number of DDMAC related warning letters issued over the last 12 months, [2] it would seem compliance regarding promotional materials is taken very seriously.

There are two high-level risk factors your organization needs to consider prior to implementing any marketing campaign. The first involves evaluating strategic risk. What factors are shaping the current regulatory environment? What is your corporate culture’s tolerance for risk? Some companies are more risk averse regarding industry regulations. On a more micro-level, how strong does your medical staff feel your empirical data is? Is your product best in class? Does it treat an underserved population? Does the product have potential to be addictive or to have extensive off-label use? (This question is critical, because companies can be cited for the promotion of off-label uses.) These are all good questions to address, because the answers will go a long way to framing your promotional campaign.

The second type of risk to consider when designing your promotional campaign is operational risk. There are many people involved in executing a promotional campaign, who must coordinate multiple activities. Are roles and responsibilities clearly defined, especially among your Medical, Legal, and Regulatory (MLR) reviewers? Are your MLR reviewers aligned with your risk strategy? From a pure operations perspective, who is shepherding promotional items through the development process from development to DDMAC 2253 form submission.[3] Finally, does your organization have the vendor relationship-management skill to effectively work with the host of vendors your organization will utilize to produce promotional materials?

What is at stake often cannot be quantified because it is hard to put a price on potential regulatory actions. However, at the very least, regulatory actions in the form of a warning letter will likely force your company to remove some of the promotional material in question from the market place. Lost time marketing your product may also have a negative impact on sales and market share.

Given the limited time that a product may enjoy patent protection, any delay in marketing can cost a significant amount. If your strategy is well devised and properly implemented, you can minimize the risk you take in promoting your product. Most leaders are willing to accept agreed-upon strategic risks. On the other hand, operational excellence in any process is a baseline expectation. Regulatory action due to poor operational compliance is likely not going to sit well with company leadership.

In closing, promoting an approved product, one that your company believes brings value to society and profitability to the company, should be one of the more enjoyable times in a product’s life cycle. If compliance with regulations regarding promotional materials is a significant concern, talk to a CIS representative about ways to improve your promotional strategy, or enhance your development process.

Sources:
[1] FDA (2008, April 9). Citing electronic sources retrieved March 8, 2009 from http://www.fda.gov/cder/ddmac/
[2] FDA (2009, February 27). Citing electronic sources retrieved March 8, 2009 from http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=D
[3] FDA (2007, October). Citing electronic sources retrieved March 8, 2009 from
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2253.pdf