The issue and debate around communications with health care professionals is at its very essence, a conversation about ensuring physicians have the best possible data to effectively treat patients. In an op-ed published in Morning Consult, Dr. R. Doyle Stulting, co-founder of the Stulting Research Center and the Director of Corneal Disease & Research at Woolfson Eye Institute noted FDA’s outdated regulations in this space and how sharing the latest information, which can improve patient outcomes, has become an increasingly burdensome venture [for manufacturers]. This is despite recent court rulings in the Caronia and Amarin cases explicitly allowing biopharmaceutical companies to provide truthful and non-misleading communications to health care professionals. Unfortunately, the FDA continues to muddy the waters with unclear guidance and inconsistent actions.
Dr. Stulting further explained how in his field of ophthalmology, medically accepted alternative uses of approved medicines are common, such as antibiotics for corneal ulcers, mitomycin for various surgical procedures, and excimer lasers for enhancements of corneal refractive procedures. He wrote, “Many patients simply cannot afford to have treatment options taken off the table for lack of information; this is especially true for those with rare diseases and those with conditions that may exclude them from FDA clinical trials—like children and pregnant women.”
Dr. Stulting remarks on what is probably already inherently clear to most, that physicians are skilled in analyzing scientific data, writing, “We are capable of evaluating the reliability of scientific publications, and we can appropriately apply this information to our clinical practice. In fact, this is an important element of our responsibility to patients and the public.”
Sharing data and new findings are critical to the practice of medicine. Limitations on the exchange of certain forms of scientific data place unnecessary burdens on patients and physicians which could ultimately restrict access to care. PhRMA continues to encourage the FDA to work with industry, health care providers, patients and other stakeholders to create a modernized regulatory framework that supports the development and dissemination of accurate, data-driven information to improve patient care.