A Perfect Storm: Oncology Drug Shortages and More on Capitol Hill

by Matt Farber, Director of Provider Economics and Public Policy, ACCC

On February 9, 2012, the House Energy and Commerce Heath Subcommittee held a hearing on Capitol Hill to discuss the issues of the generic drug user fee and the backlog of generic drug applications, the biosimilar user fee, and drug shortages. Drug shortages garnered the most attention from members of the subcommittee. Representatives wanted to know why it was happening, why it has gotten so bad, and what the FDA is doing to alleviate the situation.

Dr. Janet Woodcock, from the Food and Drug Administration (FDA) testified before the panel. According to Dr. Woodcock, a “perfect storm” of variables came together simultaneously to cause the massive amount of drug shortages. Some of these factors include the increased utilization of older generic sterile injectables at the same time that newer sterile injectables were coming onto the market. On top of that, a number of manufacturers experienced manufacturing problems that led to delays in production.

“What is the FDA doing to combat shortages and to prevent gray market distributors from raising the price on products?” members asked. Dr. Woodcock responded that the FDA is working with manufacturers to solve manufacturing problems, it has moved generic applications forward in the queue, and it has temporarily allowed importation of some products. According to the FDA, 175 shortages were alleviated in 2011. In addition, the FDA would support legislation that would require manufacturers to report impending shortages. (Bills currently exist in Congress that address this issue; click here to write to your Member of Congress to show your support.)

Dr. Woodcock mentioned that the FDA is accepting cases of gray market abuse that it would refer to the Department of Justice. NOTE: If you are experiencing issues with gray market suppliers, contact the FDA Drug Shortage Office.

Rep. Cassidy (R-LA) asked Dr. Woodcock if the FDA tracks ordering volumes of hospitals and suppliers, as a way to track hoarders and possible abusers on the gray market. Dr. Woodcock responded that the FDA does not currently track this information.

Other Representatives discussed the problems that have arisen due to drug shortages in their districts. Rep. Engel (D-NY) said that the largest hospital in his district is spending 110 hours a week on shortage-related issues. Rep. Burgess (R-TX), who is also a physician, discussed the difficulties surrounding the Doxil shortage. Not only are patients suffering from delayed treatments, but clinical trials are also being put on hold, as many trials rely on the drug for numerous reasons.

On the related topic of generic drug approvals, there were some staggering numbers discussed. Dr. Woodcock mentioned that there are currently hundreds of generic drug applications backlogged at the FDA. She said that the preferred approval time frame is 10 months, but, according to Rep. Burgess, approval time is closer to 32 months. There is a plan to address the backlog: the new generic drug user fee program will suggest a one-time $50 million backlog fee, to allow FDA more resources to clear the applications. Congress has yet to approve the legislation, but it was introduced in the House by a bipartisan group of representatives, including Republican Reps. Murphy and Pitts and Democratic Reps. Pallone and Waxman.

The final topic at the hearing was the issue of biosimilars and their approval process. Congress has looked into the prescription drug and generic drug user fee programs for guidance on the biosimilar user fee program. In addition, the FDA released long-awaited guidance on biosimilar applications after the hearing concluded.

ACCC is continuing to hold meetings with members of Congress this month, and will continue to discuss these and other important issues.