by: Assistant Account Executive Samantha Stenbeck
As a communications firm in the health sciences industry, LaVoie Group knows it is vital to be informed of compliance regulations. This is an integral part of the responsibility in being a company’s communications firm. In this mindset, participating in the seminars provided by the Center for Communication Compliance is an invaluable tool. After earning the certifications appropriate for our field, I have decided to reflect on the vast amount of information that we learned in the past several weeks. Naturally, as a public relations professional, press releases are the first topic that comes to mind when I think of the most valuable information that I learned. With a variety of clients who have investigational, approved and unapproved drugs, or approved drugs with unapproved uses, there are regulations that are extremely important to consider in the dissemination of press releases involving details about these products.
The first aspect to keep in mind is that the FDA regulates all product-specific promotional materials issued by or on behalf of a drug, biotechnology, or medical device company. Press releases are a part of this promotional category and have to follow a detailed criterion. To discuss all that it involves, one must first identify the type of product being discussed. The FDA uses Form 2253 to monitor and review all promotional press releases, which must be submitted upon initial use of the press release for an approved product by the FDA. According the FDA’s language, “all advertisements and promotional labeling for a particular drug product must be submitted at the time of initial publication or dissemination.” (FDA.gov)
Is the drug investigational or is the press release regarding an un-approved use of an approved drug? The FDA regulates the information that your company may be disseminating but does not require submission for approval. It is incumbent upon the company to follow FDA regulation on press releases on unapproved uses for drugs or investigational drugs. Most of the time, information is being discussed in a peer-to-peer medical setting and is disseminated for investor relations purposes. Is the drug approved by the FDA? Then the form needs to be filled out along with the press release and submitted for review by the FDA upon sending the release.
We then delve into the contents of each of these types of press releases. All promotional releases of approved drugs must include all material facts regarding the product. Included is a fair balance of its benefits and risks, which is defined by the same amount of information and format of text to signify the equality of information. The product’s indications, generic name included in the initial mention of its trade name, and full prescribing information must also be included. You may include any in-label information or information supported by evidence. Supportive evidence is defined by any adequate and well-controlled studies, generally double-blind and placebo-controlled for the approved use of the drug. There are many details that you may not include, such as statements about unapproved uses, false or misleading information, or quotes from investigators and doctors that are not consistent with labeling or supported by evidence. A final point that stuck out to me while completing the training was that the FDA labeling should be regarded as “the Bible,” when referring to rules for each press release.
For non-promotional releases, investigational product information can include its investigational status, a statement that more research is needed if appropriate, and indications for the drug along with a fair balance of risks and benefits. There cannot be any conclusion regarding its safety and efficacy. This rule, along with the rule regarding fair balance, were stressed several times among all of the seminars that we listened to, which signifies to me that this is not something to forget when composing a press release for a client’s product. There also cannot be any promise of approval date expectations, but regulatory milestones that have been achieved, new data from study results, the names of investigators and locations of the trials can be included in the release. Quotes from a 3rd party doctor, even if he is or she is not involved in the study are allowed including information about all key clinical trials with information regarding the disease/condition the drug is used for, and statements about the drug’s mode of action.
An unapproved use of an approved product can also be put into a press release with rules similar to an investigational product’s press release, but it must be made clear that this use is an unapproved use and can never be put into a promotional press release. The key difference between investigational and unapproved use press releases is that quotes from doctors and their experiences cannot be included.
As a component of public relations professionals’ daily routines, this is a lot of information that might be seen as general knowledge at first-glance, however, when there is a hard and fast-approaching deadline in the back of your mind, these rules may become convoluted and harder to decipher. The compliance training that our firm has completed helped with this confusion immensely by spelling out the details clearly. The Center for Communication Compliance has given us information that will be included in the most convenient pocket of our tool-belt of everyday public relations knowledge.