American Association for Cancer Research

AACR Cancer Policy Monitor

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CPM
September 2011

 

LAWMAKERS EXAMINE GROWING PROBLEM OF DRUG SHORTAGES

AACR member testifies about detrimental impact of shortages on cancer research and care

Shortages of certain pharmaceuticals have concerned clinicians and researchers for several years, and the problem has continued to worsen. The issue has now reached the point that it has captured the attention of Congress, leading a key House panel to hold a hearing entitled “Examining Increases in of Drug Shortages” on September 23.

During the first witness panel, Health and Human Services Assistant Secretary for Health Howard Koh and Dr. Sandra Kweder, deputy director for new drugs at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), detailed the extent of the problem and the steps that FDA is taking to address the shortages.

Of the 193 shortages reported so far this year by the American Society of Health-System Pharmacists, 22 are cancer drugs. Dr. Robert DiPaola, director of the Cancer Institute of New Jersey and member of the AACR Science Policy and Legislative Affairs Committee, was one of the witnesses on the second panel to testify about the effects of these specific oncology drug shortages on cancer treatment and research. He testified that the shortages are slowing or halting clinical trials, thereby hampering the pipeline of promising new cancer therapies. He also noted that during a clinical trial, a shortage of an existing drug for even just a few weeks might mean delays lasting years for the development of a new drug. Dr. W. Charles Penley testified on behalf of the American Society of Clinical Oncologists and also reiterated the dire effect of drug shortages on the care of oncology patients.

The FDA outlined a number of factors contributing to the shortages, including consolidation of the industry, just-in-time manufacturing, and quality control and manufacturing difficulties due to aging production facilities where many of the most affected drugs are made. Economic issues were also cited, as many of the drugs in question are low-profit margin generic drugs. Several lawmakers sought to better understand the relative roles of government programs, insurance companies, pharmacy benefit managers and group purchasing organizations, in addition to the developing “gray market” where drugs in short supply are sometimes hoarded and sold back at an average markup of 650 percent.

Under current authority, the FDA is able to address drug shortages in several ways, including coordinating with alternate manufacturers, fast-tracking the approval of new production facilities and allowing temporary importation of drugs in shortage. FDA can also allow exceptions for drugs or ingredients that do not meet specifications as long as they are still deemed safe and effective. An example raised at the hearing was the chemotherapeutic, cytarabine, which was in short supply due to crystal formation. Working with the manufacturers, the FDA approved a protocol that allowed the use of the product after it had been warmed to dissolve the crystals.

At this stage, most federal action is directed at understanding the problem and improving the notification manufacturers provide to the FDA when there is a discontinuation, interruption or adjustment to the production of a specific drug. Two similar bills are being considered, one in the House (H.R.2245) and one in the Senate (S.296). Both proposals would require mandatory notification of pending shortages by manufacturers, a process that is currently voluntary.

There is consensus that while these proposals may improve notification, they do not address the underlying causes of the shortages, which are still poorly understood. The Government Accountability Office is expected to release a report on this topic by the end of the year. The FDA is working on its own report, due out shortly, and is also holding a series of public meetings and webinars, with the next webinar scheduled for Friday, Sept. 30.

 

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