FDA On Solving Drug Shortages
Dr. Marta Wosinska, Director of Economics Staff at the FDA’s Center for Drug Evaluation and Research
Over the past few years, a number of critically needed medicines have gone into short supply, adversely affecting patient care and disrupting clinical trials. A production disruption preceded virtually every such shortage. These disruptions are more likely to turn into actual shortages in markets where production is highly concentrated among few manufacturing facilities, production cannot be easily shifted to other manufacturing lines, or tight production schedules limit firms’ ability to quickly ramp up production. All these are critical reasons why sterile injectable products have featured so prominently among products affected by drug shortages.