FDA’s just-issued report on drug shortages covers root causes and possible solutions in great detail but breezes by diversion and gray market factors as if they don’t exist. Most people who read this 124-page report will be totally unaware that shortage drug diversion is even a problem at all. References to it are scant, buried deep on pages 44 and 82. Blink, and you’ve missed them.
Under the Stakeholder Perspectives section on Page 44, it was reported that “Hospitals, pharmacists, and GPOs raised concerns about the gray market, which takes advantage of drug shortages by charging exorbitant prices for hard to find drugs. They believe more investigation and insight into these practices is warranted.” How long have we heard this complaint! When is this investigation going to happen?
Then, on page 82, FDA reported, “Industry recommended that FDA require national wholesalers to implement checks and balance systems for shortage drugs, similar to suspicious order monitoring requirements for controlled substances, to identify potential diversions of shortage drugs to the gray market. However, FDA’s governing statutes do not set up such systems specifically to address potential diversions of shortage drugs.” This is a great suggestion, but “governing statutes” are not a prerequisite for FDA to act on this issue. I’m not sure FDA needs legal authority to encourage industry to police its sales of shortage drugs to potential gray market parties or to provide training and increase awareness for industry about such schemes.
In July 2012 Congress reported extensively on the role of the gray market in drug shortages. This was the ultimate belt-high fastball for FDA. A home-run pitch right down the middle of the plate! But more than seven years later, the agency has yet to take the bat of its shoulders. FDA can crush the shortage drug diversion fastball out of the park like a Juan Soto blast, but that will never happen as long as the agency refuses to swing the bat.