According to a recent report, “Allergan has filed a federal lawsuit seeking a court ruling that would allow it to share relevant information with the medical community on the safe use of botulinum toxin A for certain off-label therapeutic uses, the company announced in a press release.”
The suit itself argues that the position of the government to criminalize pharmaceutical companies from proactively communicating truthful information to physicians about off-label uses of its products “violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.”
What makes the suit unique is that the U.S. Food and Drug Administration (FDA) already acknowledges “the legitimacy and importance of the off-label uses of many products, and many federal and private health plans cover off-label uses for therapeutic Botox.”
Regardless, the FDA and U.S. Department of Justice (DOJ) still assert that “federal law prohibits pharmaceutical sponsors from proactively providing information to the medical community on off-label uses even when such information is accurate and complete.”
Allergan sees this interpretation as a serious problem because the FDA requires “safety updates to the prescribing labels and a Risk Evaluation and Mitigation Strategies program for all botulinum toxin products approved in the United States, including Botox.” But Allergan contends that the company cannot update such labels with “truthful and relevant information to exchange with the medical community” because they fear being prosecuted as a result of DOJ and FDA’s interpretation of federal law.
The issues addressed in this case do not question the government’s ability to prohibit pharmaceutical companies from distributing false or misleading information about products. That issue is irrelevant to the protection Allegan seeks because the information they wish to communicate is proven scientifically.
Essentially what the lawsuit boils down to is whether Allergan can place on its label, “truthful, important information about common off-label uses of Botox.”
From filing this suit, Allergan hopes the outcome will lead to “clear regulatory guidance on how it can lawfully provide accurate and relevant information on the full range of issues physicians should consider in determining the best therapies for their patients.”
Depending on the outcome of this case, if the courts rule in favor of Allergan the decision could potentially reduce or even eliminate future legal cases and settlements based on off label marketing in cases where science clearly shows a benefit to patients. This is a gutsy move by Allergan, taking the FDA head on.
Off label promotion is a huge issue, and companies can’t directly promote off label information, this would open up a huge sales opportunity for companies. In oncology most meds are prescribed off label, and both physicians and patients want medicines fully discussed. The current FDA system ties the hands behind the backs of those who create breakthrough medications and also prevents over promising.
The case could cause a ripple effect on the medical community and is significant in the realm of continuing medical education (CME). If Allergen’s case is upheld, companies may be less inclined to support CME the only current option for supporting off label discussions. They will also be able to bypass the traditional educational program to discuss off-label therapeutic uses of medicine, and directly market such uses through salesmen and promotional meetings.
While the science may be accurate and truthful, doctors will still need the necessary exposure to clinical research and studies through CME programs that bring fair balance to make the right decision for patients.
Whatever the outcome of Allergan’s case may be, companies will still seek to support CME programs that offer fair balance, and strong scientific content this provides additional transparency and avoid potential bias.