National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
September 20, 2011 • Volume 8 / Number 18

FDA Update

Health Officials Issue Statement on Drug Shortages

Following a September 9 meeting of stakeholders to discuss solutions to the national drug shortages, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg and Assistant Secretary for Health Dr. Howard Koh issued a statement expressing their commitment to minimize drug shortages, protect patients, and identify solutions to “this serious problem.”

The FDA is analyzing the problem and will release a report with recommendations. One suggestion is a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which could help to curb drug shortages and improve the continuity of the drug supply.

The FDA is working with drug manufacturers to counteract the shortages. For example, the agency is expediting requests to qualify new manufacturing sites, new production lines, and new raw material suppliers to avert shortages.

“There is no quick solution that solves this critical public health issue; addressing it will require a multifaceted approach,” wrote Drs. Hamburg and Koh. “All parties involved in the supply of drugs to Americans have a responsibility to make sure patients have access to the drugs they need.”

Discussion of the drug shortages will continue at the FDA’s public meeting on September 26. 

Additional information on this topic can be found on the FDA drug shortage website.

Further reading: “Continued Shortage of Chemotherapy Drugs Causing Concern

Cancer Therapies Office Reorganized

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the reorganization of its Office of Oncology Drug Products last week. The reorganized and renamed Office of Hematology and Oncology Products (OHOP) now consists of four divisions organized primarily by disease site.

The Division of Oncology Products 1 is responsible for reviewing therapies for breast, gynecologic, and genitourinary cancers, as well as supportive care for nonhematologic cancers.

The Division of Oncology Products 2 is responsible for reviewing therapies related to gastrointestinal, lung, head and neck, neurologic, and rare cancers, as well as pediatric solid tumors, melanoma, and sarcoma.

The Division of Hematology Products is responsible for adult and pediatric blood cancers, and the Division of Hematology Oncology Toxicology will review nonclinical pharmacology and toxicology issues related to cancer therapies.

OHOP will be directed by Dr. Richard Pazdur, who headed the Office of Oncology Drug Products. The reorganization “aligns FDA with the organizational structure of leading cancer treatment centers, academic programs, and the National Cancer Institute,” Dr. Pazdur said in a news release. The reorganization is expected to lead to “greater efficiencies” in the review process of cancer therapies, added CDER Director Dr. Janet Woodcock.