The House of Representatives Energy and Commerce committee’s Subcommitee on Health spent Friday, Sept. 23, 2011 in the hearing, Examining the Increase in Drug Shortages. As of the date of publication, the colorectal cancer chemotherapy agents on the official Food & Drug Administration (FDA) drug shortages list include 5FU, Leuocovorin and Irinotecan, the main components of the Folfox and Folfiri chemotherapy regimens.
Expert witnesses who testified at the hearing included these eight representatives from cancer treatment centers, the pharmaceutical industry and health and human services experts:
- Howard K. Koh, Assistant Secretary for Health, U.S. Department of Health and Human Services
- Jonathan M. Kafer, Vice President Sales and Marketing, Teva Health Systems
- John Gray, President and CEO, Healthcare Distribution Management Association
- Kevin J. Colgan, MA, FASHP, Corporate Director of Pharmacy, Rush University Medical Center (on behalf of the American Society of Health-System Pharmacists)
- Mike Alkire, Chief Operating Officer, Premier Inc.
- W. Charles Penley, MD, Tennessee Oncology (on behalf of the American Society of Clinical Oncology)
- Richard Paoletti, Vice President, Operations-Pharmacy, Laboratory, and Radiology, Lancaster General Health
- Robert S. DiPaola, MD, Director, Cancer Institute of New Jersey
See the video accompanying this article to hear all of the testimony presented during this hearing. To read full text of the witness testimony, visit the House Energy and Commerce Committee.
Kate Murphy, Research Communication Director of Fight Colorectal Cancer (FightCRC), analyzed the hearing testimony and blogged a informative summary on Sept. 26. According to Murphy, some of little-understood facts about the shortages of critical drugs include complexity of the manufacturing process, the small number of companies that make some of the drugs in shortage, and aging pharmaceutical manufacturing infrastructure that makes it hard to maintain production.
Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and complicated to manufacture, made by a only a few companies, and manufactured in aging plants where quality is hard to maintain. – Kate Murphy, FightCRC
Dr. Koh provided several critical facts and figures to the subcommittee about the increase in drug shortages from 2010 to 2011. Cancer and chemotherapy drugs accounted for 28% of all shortages, and antibiotics were the next most common drug affected.
Koh also revealed that only 11% of the drug shortages were directly caused by a manufacture who ceased drug production for business reasons. 54% of all drug shortages resulted after quality control issues were discovered in drugs manufactured in older plants. 21% of the shortages were due to production delays. Another 10% of shortages were the result of problems getting raw materials, lack of components, and loss of a manufacturing site.
According to Koh, another issue resulting in drug shortages was that increases in demand for the drug at other plants after one manufacturer had to delay or cease production overloaded the capacity of the manufacturers that could still prepare the drugs. Allowing market need to control prices wouldn’t work in the present system, according to Koh, most drug prices are set by contracts. Contracted pricing cannot respond to short-term shortages.
Koh also cited the pressure that pharmacy benefit managers and other drug purchasers who buy in large quantities that they put pressure on prices to keep their wholesale costs low. He also noted that manufacturers may not have necessary capital to expand production when shortages hit the market.
Rep. Diana L. DeGette (D-Colo.) told the subcommittee about the Preserving Access to Life-Saving Medications Act (H.R. 2245) which would require manufacturers to notify the FDA at least six months in advance if they are planning to discontinue a drug, and notify the FDA as soon as they are aware of a problem for any other potential disruptions in manufacturing. The Act, which is awaiting approval, also provides penalties for non-compliance.
FightCRC has created a way for readers to urge their congresspeople and senators to support the Preserving Access to Life-Saving Medications Act (H.R.-2245) and its Senate companion bill S-296. FightCRC also plans a webinar on Nov. 16, 8 – 9:30 p.m. EST: What to do when your doctor is out of 5-FU (or Leucovorin, or Irinotecan.) Register in advance for the webinare at the FightCRC website.
Congress Probes Drug Shortages, Fight Colorectal Cancer Research & Treatment News by Kate Murphy
Examining the Increases in Drug Shortages, Committee on Energy and Commerce, Health Subcommittee hearing, Sept. 23, 2011 (video and online witness testimony)
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