Recently, Arizona became the first of what may be a growing number of states to allow pharmaceutical companies to promote off-label use of their drugs. While it’s not illegal in most cases for doctors to prescribe drugs for alternate indications when they deem it appropriate, pharma companies have been prohibited in promoting their pharmaceuticals for off-label use.
The Goldwater Institute, which was behind this legislation in Arizona, plans to take the law to other states.
An Important Role for Medical Affairs Professionals
While the Free Speech in Medicine Act is currently only in place in Arizona, and pharma companies must still comply with existing federal laws, this potential trend presents some opportunities for Medical Affairs professionals to think about ways to best connect with physicians to initiate conversations. As the bridge between R&D and marketing, they hold a trusted place in the minds of many physicians and healthcare administrators. They already have relationships developed with the prescribing physicians, and shifts like this can further facilitate communication.
Christina Sandefur, the author of the model language the bill was based on, said in a Goldwater Institute article, “Curbing the exchange of information about off-label treatments by those with the most knowledge about the drug’s uses, risks, and side effects not only prevents patients from receiving the best possible care; it violates the constitutional right to free speech.”
Pharma now has an opportunity to learn from Arizona physicians and discuss issues about the Free Speech in Medicine Act — and should be preparing to take those learnings to a broader market as other states follow suit. Here are three things to keep in mind:
- Arizona is the first of what may be many states that adopt similar legislation.
- The focus is on off-label use that is based on “truthful research and information about FDA-approved medicines.”
- Physicians and other providers can ask trusted Medical Affairs professionals for reliable answers on off label use in most cases.
Listen to Learn
Effective communication requires conversation, not just a one-way delivery of a message. While pharma is in a good position to serve as a trusted source of information about the implications of the Free Speech in Medicine Act, taking a step back to first understand the issues and implications that matter most to the physician audience can yield important insights. This legislation provides a ready-made opportunity to gather information from medical experts:
- Do physicians support the bill? Why/why not?
- In what ways do physicians believe the bill will positively impact their practices and their patients?
- Are there obstacles or negative implications perceived by physicians?
- What channels of communication do they find most useful for attaining information about appropriate off-label use?
Your organization may already know the answers to some of these questions. If not, it’s important to take some steps to find these answers before starting a communications effort. Studies are indicating a shift in physicians’ preferred methods of receiving information with a decline in preference for sales reps (down 26 percent), pharmacists (down 18 percent) and colleagues (down 10 percent), and an increase in preference for information gleaned from academic journals (up 7 percent), manufacturer websites (up 9 percent), key opinion leaders (up 16 percent) and continuing medical education/conferences (up 23 percent). This knowledge of where physicians prefer to get their information should impact whatever outreach strategy you develop.
Other Issues to Consider
As you explore other ways to understand and process this new law, here are some questions you should be asking yourself:
- Do you have information on your website about the bill, along with your position?
- Have you contacted physicians who are already part of your networks to invite them to seek additional information from you?
- Do you need to redesign and/or develop collateral materials (including reports, white papers, and fact sheets)?
- How does this impact the commercial side of our organization?
Finally, don’t overlook the power of communicating with your own, internal staff and understanding their points of view as well.