Report blames FDA for drug shortage crisis; FDA defends its enforcement actions

June 18, 2012

Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.

Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.

The House Committee on Oversight and Government Reform, chaired by Rep. Darrell Issa (R-CA), states in the

report

, FDA’s Contribution to the Drug Shortage Crisis, released Friday, “The drug shortage crisis that took off in 2010 began shortly after Margaret Hamburg became FDA commissioner. Since this time, 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.”

The report argues that warning letters from the agency have essentially caused manufacturers to shut down a number of manufacturing lines. “While many of the facilities were older and the upgrade to certain facilities was desirable, the simultaneous, large-scale shutdown of manufacturing lines at most major domestic producers of generic injectable drugs has plunged America into a public health crisis,” the report states.

Although over-aggressive FDA enforcement is the primary issue, the committee report says, other factors in the shortages include group-purchasing organizations contributing to “both inflexible prices in the market for generic injectable drugs and growing market concentration.” Further, it contends the Medicare Modernization’s Act changes in pricing have cut the reimbursement for older, generic medications administered in non-hospital settings.

An e-mail response provided by FDA spokesperson Karen Riley says the increase in drug shortages, “is a complex problem that is largely the result of inelasticity of manufacturing capability, market forces causing reduced prices, and firms’ inadequate investment in manufacturing quality.”

The FDA statement argues that although the agency did send warning letters, all the companies that stopped producing drugs did so voluntarily after determining that continued production would endanger patients.

Asserting that the agency considers the risks of a shortage versus the risk of poor quality or unsafe product in any enforcement action, the FDA statement says, “Manufacturing problems that prompted potential shortage situations have included particulate matter (glass shards, metal, fiber, other materials) in the vials, which can cause severe consequences if injected intravenously; and bacterial or endotoxin contamination, which can cause infection or a shock like syndrome, and other serious defects.”

In response to the committee’s accusation about a sudden increase in warning letters, the FDA statement says that of the 1,720 warning letters the committee cited for fiscal year 2011, 1,040 were tobacco warning letters, resulting from its new authority from Congress over tobacco at the retail level.