Press Release

PhRMA Statement Regarding Drug Shortages

PhRMA April 26, 2013

Washington, D.C. (August 21, 2011) — Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President Karl Uhlendorf issued the following statement today regarding drug shortages:

“America’s biopharmaceutical research companies are deeply concerned with patients’ well-being and their ability to get needed prescription medications. Their commitment to patients is evidenced by their tremendous investment in the discovery and development of new medicines.

“As recognized by the Food and Drug Administration (FDA) and other experts, the majority of drug shortages have involved generic drugs, with the FDA specifically referring to an increase in shortages among ‘older sterile injectable drugs.’ In the less frequent instances when shortages occur with brand-name medicines, brand manufacturers take aggressive actions to remedy the situation, communicating with and working closely with the FDA to resolve the problems that are identified.

“We cannot speculate about the causes of, or responses to, those generic drug shortages. However, shortages associated with brand-name medicines can be related to myriad factors, including shifts in clinical practices; wholesaler and pharmacy inventory practices; raw material shortages; changes in hospital and pharmacy contractual relationships with suppliers and wholesalers; adherence to distribution protocols mandated by the FDA; individual company decisions to discontinue specific medicines; natural disasters; and manufacturing challenges.

“Drug shortages of any kind are a complex problem that requires broad-based solutions from all stakeholders – including innovative biopharmaceutical research companies and generic manufacturers, whose products accounted for nearly 80 percent of prescriptions filled last year.

“Regardless of the cause, in order to provide patients with uninterrupted access to medicines it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines.

“PhRMA member companies accomplish that by our commitment to maintaining good manufacturing practices and working closely and collaboratively with the FDA, supply chain partners and providers when unexpected – and rare – shortages occur.

“We look forward to studies of this important issue to provide further insight.”