Abstract

The FDA has an abiding interest in making sure that prescription drug advertising complies with regulations and does not compromise patient safety. In recent years, FDA surveillance of advertising and promotional materials has heightened. From a risk management perspective, this climate makes it imperative that companies develop and follow an effective process for producing materials that comply with FDA regulations while maintaining a competitive position in the marketplace.

Making sure that prescription drug advertising complies with regulations and does not compromise patient safety is a key focus of FDA activity. For professionals charged with managing the regulatory issues surrounding the promotion of ethical and biological pharmaceuticals, this means being sure that the advertising material produced by our companies conveys a fair and balanced message, while still maintaining an effective competitive position in the marketplace.

Over the last few years, I have been involved in the regulatory review of promotional materials for both over-the-counter and prescription drugs. My experience has led me to conclude that an effective internal review process is an important part of producing promotional materials that are in compliance with FDA regulations. An excellent way to facilitate this process is to establish a standing multidisciplinary committee that meets on a regular basis, has a formal structure and is mandated by upper management to review all promotional materials. There are a number of factors to keep in mind in order for such a committee to function properly.

First, the committee must have the right interdisciplinary mix to do the job. Members on the committee should include representatives from regulatory, medical, legal and marketing, since each of these team members brings a different agenda and perspective to the review. The medical reviewer interprets the medical statements being made to be sure they are substantiated by the clinical studies and the approved labeling for the drug. The legal reviewer addresses such issues as how language should be written to minimize liability, how to deal with patent questions and whether or not the promotional material conforms to existing law. The marketing representative provides information on how a piece will be used so it can be reviewed in the proper context. Marketing may also choose to have a representative present form the advertising agency that created the particular campaign, to help explain the message the pieces are trying to convey. The regulatory affairs representative reviews the materials from yet a different perspective to make sure they are balanced, truthful and not misleading.

Second, the committee must have enough authority to do an effective review. Upper management has to support the committee as its representative on advertising issues and must stand behind the committee's decisions. The reviewers on the committee must come from the appropriate level of management, since the decisions they make about what is acceptable promotion can have far-reaching consequences for the company.

The next important factor is that the committee should develop an authorization sheet to be attached to each promotional piece. There should be a place on the sheet for each of the technical reviewers to sign and make necessary comments. All pieces should be approved on the record. It is important to maintain a written record of any changes and to keep it in the official file for the product.

Another important component of this process is to have the regulatory affairs professional provide information on advertising regulations to help keep other committee members informed of any changes that could impact on promotion of the company's products.

Draft promotional materials with references should be provided to the technical reviewers three to five business days before a meeting. Promotional materials can be very time consuming to review, particularly lengthy pieces such as product monographs, slide kits or reprints. It is absolutely essential to have enough lead time to do a proper job of reviewing these materials, especially if there are problems with some of the language and changes need to be made.

If one of the regular committee members cannot be present for a meeting, avoid sending a substitute. A person must have an opportunity to study the FDA correspondence on the product for which materials are being reviewed or something could be approved that is not consistent with prior communications from the FDA.

Review all proposed promotional materials for a given product. Several different media such as television, the telephone and the Internet are being used to promote products today. Materials transmitted through alternative media are subject to the same regulations that govern the more traditional forms of print advertising. Be sure your review is inclusive.

Go back and re-review materials that have been in use for some time. Old materials could contain outdated safety information or they could be out of compliance with FDA guidance documents or regulatory letters your company might have recently received.

Keep a record of your meetings and decisions that is consistent with the record-retention policy at your company. If, for example, your company keeps meeting minutes for two years, you should probably keep the drafts of materials you have discussed at promotional review meetings for that same period of time. If you don't have a policy or you don't know what your company's policy is, work with your legal department to make sure that your internal practices are consistent.

Don't allow people to disregard comments and changes made to materials at the meetings or to make additional changes later on. There is a real danger in this practice, as the changes could affect the slant of the message being portrayed and be enough to make a piece that was acceptable, misleading and violative. If any changes are made to a piece after a meeting, the piece should go back to the technical reviewers for re-review.

If the committee cannot agree on an issue that seems to carry some risk, have a mechanism in place to bump the decision-making to a higher level. Generally, the members of the committee should have the authority to make binding decisions regarding the content of the advertising materials that the company will send out. They should only need to bump decisions to the next level if there is a great risk involved and a particular campaign is very controversial.

While having a system in place to review promotional materials is a positive thing, there can be some disadvantages. Larger companies tend to have more formal processes and this can slow things down. This could be perceived by marketing as a real overstepping of authority on the part of personnel not directly involved in selling the product. There are companies that have formalized the review process to the extent that checklists have been developed with lists of allowed claims for each product. This type of practice tends to be restrictive and to stifle creativity.

Not all of the points discussed above would be workable in one type of organizational structure versus another; they represent an ideal that would have to be adjusted to fit within a company's unique corporate culture. Regardless, having such a process in place is important for the development of creative materials that still conform to federal regulations.

Copyright 1999 by the Regulatory Affairs Professional Society (RAPS). Posted with permission on CNA HealthPro's Advanced Medical Technology web site. Reprinted from the June 1997 issue of Regulatory Affairs Focus. This article may not be published, reposted or redistributed without express permission from RAPS and payment of appropriate fees when applicable. To obtain such permission, send a message to jbass@raps.org. The RAPS web site may be accessed at http://www.raps.org.