(WASHINGTON)–A new report from the House Committee on Oversight and Government Reform documents a critical shortage of generic injectable medications that has occurred following enforcement activity by the Food and Drug Administration (FDA) at companies and facilities where the drugs are made. Click here for a copy of the full report – FDA’s Contribution to the Drug Shortage Crisis.
Chairman Darrell Issa (R-CA) said the Committee has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of the country’s largest producers of generic injectable medications. In response to FDA action, companies that produce generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors doing the same. Of the 219 drugs listed on the American Society of Health System Pharmacists (ASHSP) shortage list as of February 21, 2012, at least 128 – 58% of the drugs on the shortage list – were produced by at least one facility undergoing FDA remediation.
The report is the result of an ongoing examination conducted by The Committee. It found that since 2010 when the shortage crisis began, Commissioner Margaret Hamburg and the agency have failed to ensure that ongoing enforcement is conducted in a manner that does not create unnecessary shortages or have unintended consequences.
“Among shuttered manufacturing lines that occurred over the two previous years, the Committee’s review did not find any instances where the shutdown was associated with reports of drugs harming consumers,” Chairman Issa said.
“It is also important to note that the overall damage inflicted by the FDA’s decisions to shutter manufacturing lines may extend well beyond the current drug shortage crisis. This shortage of injectable generic drugs is only the most visible result thus far of FDA enhanced enforcement action,” Chairman Issa added.
“This shortage appears to be a direct result of over aggressive and excessive regulatory action. Addressing this shortage requires a common sense regulatory approach that considers market conditions and the overall impact,” Chairman Issa said. “These drugs can save lives and keep people who need them living healthy lives. The FDA is failing to ensure the availability of quality products.”
|Staff Report: FDA's Contribution to the Drug Shortage Crisis||Document|