FDA Efforts on Drug Shortages Told at Policy Conference
FDA commissioner Scott Gottlieb says failures in policy and economics over many years are responsible for the current increase in drug shortages. Speaking 11/27 at a Duke University Margolis Center for Health Policy conference on “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” Gottlieb described agency efforts through his new Drug Shortage Task Force. He said the group has held listening sessions with various stakeholders and has heard of a need to increase awareness of shortages as a way to promote accountability, the need to eliminate some barriers to manufacturers entering the market, and the need for contract language to help prevent shortages.
In a panel following Gottlieb’s remarks, FDA associate commissioner for strategic initiatives Keagan Lenihan said members of the task force have conducted several listening sessions as part of their charge to take a new, broader look at the issue. She said they were surprised to learn the rate of shortages. Those attending the sessions attributed the causes to market factors, a lack of transparency, and difficulties in navigating the various authorities of federal agencies involved in drug shortages, she said.
CDER deputy director Douglas Throckmorton said the goal of FDA’s response to drug shortages is to maintain availability while minimizing risk to patients. He asked the audience to be aware that there are some things FDA cannot do, including requiring a drug company to disclose why there is a shortage, requiring a company to make a drug, requiring a company to make more of a drug, and dictating to a company how much of a drug to make and to whom it is distributed.
“Recovering from a drug shortage takes time,” Throckmorton said. “Prevention is always better than waiting until a shortage occurs.”
CDER senior operations research analyst Matthew Rosenberg reported on an economic data analysis showing that ongoing drug shortages have become more prevalent in the last year or so. The shortages are lasting longer, he said, have a high intensity, and have a high public health impact.
Finally, CDER Office of Program and Strategic Analysis deputy director Adam Kroetsch said shortages primarily affect older generic injectable drugs used in hospitals. The root cause of many shortages, he said, appears to be the failure of the marketplace to reward quality and reliability. Issues he cited included tightening profit margins, aging facilities, company inventory practices, and industry consolidation.