Approximately 30% of all prescriptions in the United States are for off-label use according to several studies. This is a drastic increase from just a few years ago, when approximately 20% of all prescriptions were for off-label use. Medications that are used in their “unintended” capacity and outside of their FDA-approved indicated usage may not have readily available scientific evidence supporting exactly how the medication was prescribed. Even the FDA has stated that “[g]ood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgment.”
However, physicians are allowed to use their clinical discretion and professional judgment as part of their regular course of practice. In doing so, they are permitted to use and prescribe medications “off-label” to establish proper patient care, provided it is consistent with the appropriate standard of medical care. Recently, the FDA drafted guidance emphasizing how pharmaceutical companies and similar firms should communicate with doctors about research into the off-label use of medical devices and drugs.
In its Guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products,” the FDA expressed how pharmaceutical companies and similar firms should communicate with doctors about research into the off-label use of medical devices and drugs. The guidance specifically calls for studies shared with physicians to provide information important and beneficial to their patients, rather than just general case studies that are not necessarily applicable.
First, the FDA guidance emphasized that randomized, double-blind, concurrently controlled superiority trials are usually regarded as the most rigorous design and informative to clinical practice, and therefore the most likely to provide scientifically sound and clinically relevant information. Certain studies without an adequate comparison or control group, reports about medical products, and other reports lacking sufficient enough detail to permit scientific evaluation would generally not be clinically relevant. Thus, it is important that the studies be peer-reviewed by unbiased experts so providers can interpret the strengths, weaknesses, validity and utility of the information about the unapproved uses of drugs.
Next, the FDA highlights that the manufacturers are allowed to only relay wholly truthful and non-misleading information to physicians. Making false or misleading claims about off label medical products can lead to legal consequences. The FDA has long taken the position that a medical device or drug manufacturer who promotes any unapproved uses of FDA-approved devices/drugs is in violation of the FDCA. The FDA has previously asserted that off-label promotion may lead to misbranding of the product and circumvention of the regulatory approval process that is taken to ensure product safety and efficacy.
Additionally, the FDA guidance discourages persuasive marketing techniques which influence use of the products based on elements other than the scientific content of the communication. Some examples of persuasive marketing techniques include the use of celebrity endorsements, premium offers, and gifts. An attempt to use persuasive marketing techniques is seen by the FDA as an attempt to mislead healthcare providers into prescribing or using a product for an unapproved use when they otherwise would not choose to do so.
Off-label promotion regulations and policies are actively changing, and marketing off-label use of medical products carries significant legal risks. It should be emphasized that the manufacturers are allowed to relay wholly truthful and non-misleading information to physicians. Thus, in accordance with the FDA’s new guidance, pharmaceutical companies can continue to contribute to healthcare, invest in research and development of drugs, and ultimately improve patients’ quality of life.
How Frier Levitt Can Help
In all, it is important to ensure that marketing efforts comply with applicable laws and regulations to mitigate legal risks. Frier Levitt attorneys have spent hours reviewing the new laws and guidance, as well as communicating with the FDA. Frier Levitt has worked closely with pharmaceutical manufacturers and biotech firms in understanding off-label promotion and current FDA policy and regulations. We have a team of attorneys who understand the bounds of the industry standards surrounding these issues. If you have questions, contact us to speak to an attorney.
