WASHINGTON—The recent nationwide shortages of critical drugs, including oncology agents, are largely the FDA's fault, according to a congressional committee report.
Since Margaret Hamburg, MD, became FDA commissioner in 2010, "the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs," reads the report issued by the House Committee on Oversight and Government Reform.
The committee said that "although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, [an investigation found that] the crisis was largely sparked by actions of the Food and Drug Administration."
When the FDA responds to a manufacturing problem involving producers of generic injectable drugs, the result is that "companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line. These simultaneous shutdowns diminish the ability of competitors to alleviate the shortages with increased production," the report noted.
The FDA's regulatory interference in the production process has "effectively" forced the shutdown of 30 percent of the total manufacturing capacity of four of the largest manufacturers of injectable drugs: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals, according to the committee, which is chaired by Rep. Darrell Issa (R-Calif.).
Of the 219 drugs listed on the American Society of Health System Pharmacists shortage list as of February 21, at least 128 (58%) were produced by at least one facility undergoing FDA remediation, according to the report. A committee review of those manufacturer shutdowns over the last two years "did not find any instances where the shutdown was associated with reports of drugs harming customers."
