A year ago, the Food and Drug Administration created a Draft Guidance regarding the advertising of prescription products in the broadcast media directly to consumers. The driving force behind this was to facilitate the awareness of new pharmaceutical treatments and encourage a more educated dialogue between patients and their physicians.
The final guidelines, which will be out soon, will be the cumulative result of many conversations with physicians, managed-care companies, pharmacists, consumer advocates and pharmaceutical manufacturers.
The guidance allows the disclosure of “claims,” which are indications for the products advertised, in both television and radio. Before then, drug makers only had two options for the broadcast advertising of their products. The first was to feature a nonbranded message about a disease directing patients to see their doctors to find out more about specific medications and the company that made the drug. The other option was to use a branded message, but the ad couldn't disclose the specific diseases or conditions that the advertised products were designed to treat. The latter approach created a great deal of confusion and was very unproductive.
The FDA guidance also specifies that the broadcast ads must include two more pieces of information. Along with the “indication,” what the product is approved for, there has to be a “major statement,” a disclosure of warnings. In addition, each ad must provide consumers with “adequate provision,” which is product information, that can be mailed, faxed or read over the telephone (and received) within four to six days of a patient's request. In some cases, manufacturers have been directing consumers via their broadcast ads to the information found in specific print ads as another way to obtain information.
The pharmaceutical industry has taken full advantage of this opportunity. Drug makers have been featuring spots for products that treat both chronic and acute conditions, including advertising for “lifestyle drugs” such as those for impotence and smoking cessation. The impetus behind the major broadcast rush has been that these messages can reach huge amounts of consumers, a number of which will ask their doctors for specific products.
In taking advantage of this Draft Guidance, some companies are using a classic mass-marketing approach. In this approach, ad agencies develop scientific media plans and advertise the product in both print and broadcast media. They are throwing a wide net and hoping to snare the patients who will go see their doctors. These companies will display a phone number only because they have to adhere to the “adequate provision” stipulation. On the other side, some companies think consumers aren't easily affected by 30-60 second spots alone and they are aggressively populating databases of patients via direct response to displayed 800 vanity numbers.
Certain companies are opting not to use the media approach and move directly to methods such as business reply cards in product starter packs (distributed to doctors by sales reps) and “take ones” in physicians' offices and pharmacies. Their ultimate goal is to establish and nurture long-term conversations and relationships with patients. This is referred to as direct-to-patient marketing. In most cases, patients are asked if they would like to receive ongoing communications and other value-added vehicles at no cost (opt-in option).
This direct-to-patient approach has a “patient acquisition” focus combined with a “retention” emphasis (the ideal combination), which provides an invaluable service to patients, physicians, pharmacists and the healthcare system at large. The power of retention strategies and tactics is starting to be appreciated and more advertising and promotion dollars are being allocated to these key activities. The ultimate goal is to improve drug compliance and build long-term loyalty.
The good news is that in the grand scheme there seems to be a consensus among all stakeholders that fair, balanced direct-to-consumer/direct-to-patient communications are a good thing.
Chris Campbell contributed to this article. Julian M. Parreño is vice president of pharmaceuticals and Chris Campbell is vice president of sales at Harte-Hanks Direct Marketing, Lenexa, KS.