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Robert G. Bell

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC.

The United States has been plagued recently by significant drug shortages that critically affect the healthcare of the hospitalized and most vulnerable patients. It is my feeling that the drug shortage situation will make drug rationing a reality. In late 2010, Duke University Medical Center came within two days of running out of cytarabine, a chemotherapy drug that is integral in curative therapy for adult and childhood acute myelogenous leukemia and childhood acute lymphoblastic leukemia. What would the treating physicians do if they had enough for only one patient and several were in need of treatment? How does the physician choose—first-come first-served, lottery, young versus old? This is the reality of drug shortages. These shortages aren’t only limited to cancer drugs but also include antibiotics, anesthetics, vaccines, and medications to treat attention deficit hyperactivity disorder, among others. Over the past five years, drug shortages have significantly risen, increasing from 70 to over 230 in 2011. Why, in such an advanced country such as the United States, is this happening?

The causes of drug shortages are many and complex and include product quality manufacturing issues, product lifecycle management, active pharmaceutical ingredient supply, and profit incentives. In February 2012, the U.S. government and Food and Drug Administration (FDA) intervened to resolve the critical cancer-drug shortages, allowing shipments of drugs from India and Australia to fill the gap. The White House issued an Executive Order directing FDA to expand its authority to police drug shortages, including requiring all manufacturers to notify the agency of impending shortages and requiring FDA to report any violations of the government’s price controls on generics. FDA’s Early Notification Program of potential disruptions in drug supply has made a big difference. Since FDA reached out to the industry, there has been a six-fold increase in early notifications from manufacturers. Also in that six month time frame, FDA has been able to prevent 128 drug shortages and are seeing fewer numbers of shortages occur—42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year, as reported by FDAVoice. Timely industry communications to FDA regarding drug shortages is critical. The industry and government should have contingency and response plans for critical drugs and provide incentives and opportunities to manufacture older, critical generic drugs. This might be accomplished by investors using available facilities or collaborations between academia and industry, which could provide the drugs in need for the regional hospitals as well as provide graduate training in chemistry, manufacturing, and controls and regulatory sciences associated with producing these critical drugs.

There will be a drug shortage hot topic session at the 2012 AAPS Annual Meeting and Exposition in Chicago on October 17, 2012, which will include industry, academic, and government perspectives for alleviating the drug shortage crisis in the United States. Participants will have the opportunity to discuss solutions that should lead to prevention of the compromised or delayed care, or deaths in some cases. I look forward to seeing you there.