Imagine your child or spouse is suffering from an illness with few effective treatment options, such as a rare pediatric cancer or autoimmune disease. Meanwhile, a team of doctors and researchers has been steadily working to unlock the mysteries of this disease for years, in an ongoing effort to identify better solutions for patients. The team has just published promising results from a recent study in a respected medical journal. The study involved so-called “off-label use” of a prescription drug for these patients, i.e. administering a drug already approved by FDA, on the market, and prescribed by doctors for a related but different medical condition.
In an ideal world, your physician would be familiar with this newly-published study and might initiate a conversation about the potential of this alternative course of treatment for your loved one’s condition. However, the medical world is vast, and new developments occur continuously. There is no guarantee that your physician will be aware of or have ready access to information about this particular journal article or line of research amid his or her busy practice. While pharmaceutical companies are well-positioned to facilitate the dissemination of such scientific data to the appropriate clinicians, restrictions on their activity concerning “off-label promotion” have made this possibility astoundingly complicated.
If your business operates in a FDA-regulated space, you are no doubt acutely aware of the “boundary disputes” and aggressive enforcement activity relating to off-label promotion of FDA-approved products. As you know, overstepping the boundaries – even with the best of intentions to help patients – quickly brings forward the specter of “whistleblower” lawsuits, multi-million dollar fines, and onerous settlement agreements with the government. Understandably, many companies have thus invested significant resources to avoid enforcement action of any kind, effectively placing a gag order on their personnel and managing compliance through strict guidelines, employee trainings and comprehensive insurance policies.
Unfortunately, as illustrated above, FDA-regulated businesses are not the only ones impacted. Caught in the fray are thousands of patients in dire need of more effective treatment options. For them, off-label promotion is simply a matter of potentially life-changing research and information being freely shared with their physicians, who can then evaluate it on scientific grounds in the context of their specific patients.
The good news is that the regulatory pendulum may be shifting a bit more toward center. Successful challenges to the FDA brought by pharmaceutical companies on First Amendment grounds (the Caronia and Amarin decisions) have loosened the regulatory grip, upholding the right to “truthful and non-misleading speech” in the context of promoting off-label use of an FDA-approved drug. One commentator noted that as a result of the developing case law, “[T]he ability of FDA to effectively ban off-label promotion has been seriously called into question.” Indeed, FDA has signaled something of a retreat. It recently withdrew an off-label Warning Letter previously issued to Pacira Pharmaceuticals, granting the company a number of concessions in a settlement agreement widely viewed as a victory for the industry.
Given the extreme measures taken in the past by both FDA in its aggressive enforcement, and by pharmaceutical and medical device companies in response, many companies are re-evaluating. Using recent developments as a guide, and with the help of an experienced attorney, a review of current SOPs may reveal opportunities for calibrated adjustments and useful changes to your off-label compliance program. To discuss further, please contact Emmy Hessler at email@example.com or (508) 808-4001.