On October 31st, the FDA released the agency's Congressionally-mandated report titled, “Drug Shortages: Root Causes and Potential Solutions.” The 124-pg report found drug shortages are increasing, persistent, i.e., the duration longer, with both the intensity and public health impact high. These shortages can, the FDA found, “have a devastating effect,” by prolonging patient suffering, contributing to disease progression & increased morbidity. Concerning root causes, the FDA found market consolidation has caused current contracting practices to constitute in sum a “race to the bottom.” The FDA also found the market also fails to recognize or reward manufacturers for mature quality management systems and found a market that is unable to quickly recover after a disruption in either manufacturing or supply chain distribution. Despite the worsening drug shortage problem, and the Congress’ considerable focus on drug pricing legislation this year, not a single drug shortage committee hearing was held this Congressional session or this year. (Listeners may recall I posted in August a related essay I wrote on this topic for STAT).
During this 28 minute conversation Captain Jensen begins by providing an overview of her day to day efforts managing the FDA's drug shortage efforts. She moreover discusses the details of the FDA's report to the Congress, principally the report's recommendations, potential other related solutions including improving risk management planning, stockpiling and lengthen expiration dates, efforts by Civica Rx and Provide GX, forthcoming FDA drug shortage guidances and potential for Congressional action.
Captain Valerie Jensen is the Associate Director of the Drug Shortage Staff at the Food and Drug Administration. She previously worked as a clinical pharmacist for Indian Health
Service hospitals in Arizona and New Mexico for nine years before joining FDA. She has been with the FDA for the past 19 years leading FDA efforts to work with manufacturers to mitigate and resolve shortages of medications for the patients who depend on them. Captain Jensen received a B.S. degree in Pharmacy from the University of Iowa in 1990 and upon graduation was commissioned as an officer in the U.S. Public Health Service. She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991.
A related and recent Civica Rx report is at: https://civicarx.org/wp-content/uploads/2019/10/Civica-Rx-White-Paper-FINAL-10.01.19-1.pdf
Again, my related August STAT essay is at: https://www.statnews.com/2019/08/09/drug-shortages-presidential-candidates-policy/
(In my opening statement, I misspoke. The drug shortage problem adds at least approximately over half a billion (not half a million), dollars annually to healthcare spending.)