Last week, the Food and Drug Administration (FDA) imposed a Risk Evaluation and Mitigation Strategy (REMS) on AR Scientific regarding the malaria drug Qualaquin (quinine sulfate), which is used to treat or prevent night-time leg cramps.
Specifically, the REMS seeks to curb off-label use of the drug by requiring the company to send a “Dear Health Care Provider letter and provide a Medication Guide to patients explaining what Qualaquin is and is not approved for, as well as the potential side effects – notably thrombocytopenia, a potentially life-threatening syndrome involving a low level of platelets in the blood.”
Consequently, the FDA is using the letter as a "Communication Plan" part of the REMS, which will be sent to the executive directors or professional relations departments of the Infectious Diseases Society of America, the American Academy of Family Physicians, the American Academy of Sleep Medicine, the American College of Physicians, and seven other professional organizations.
The REMS will also require physicians, when prescribing Qualaquin, to explain to patients about the signs of thrombocytopenia, including easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin.
In connection to this specific REMS, FDA Principal Deputy Commissioner Joshua Sharfstein noted during a recent conference, that REMS “is a useful tool in stopping off-label drug and device promotion in continuing medical education classes because it "allows the FDA to make companies fund educational programs [about a drug's risks] that companies otherwise wouldn't do."
With this recent development, it will be interesting to see what role educational grants provided by industry will play in educating physicians about off-label uses of drugs through CME. Clearly, by the FDA beginning to require companies to fund such programs about a drug’s risks, the agency has recognized that commercial support of education can and does provide significant and important information to doctors.
In fact, if more commercially funded CME were used, such programs could educate physicians about off-label issues and risks as a way to prevent issuing a REMS in response to a negative consequence or concern. As a result, if FDA is willing to allow commercial support of CME in response to REMS, there should be no different standard within other federal agencies regarding the use of industry supported CME.