Regulatory Focus™ > News Articles > FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages

FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages

Posted 25 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products.

The original report, FDA's Contribution to the Drug Shortage Crisis, claimed FDA had "largely sparked" shortages through its increased reliance on facility inspections and monitoring of regulatory compliance activities.

"Information obtained by the Committee shows that the FDA has not had a sufficient focus in ensuring access to and a continued supply of needed medicines over the last several years," wrote the committee in the report. "Although manufacturers are reluctant to speak publicly about problems with their governing agency, the Committee found that the new political regime at FDA is largely to blame for the sudden spike of shortages that began in 2010."

In particular, the report highlighted both the increase in Warning Letters sent by the agency between 2010 (474) and 2011 (673) and the agency's allegedly callous approach toward single-source manufacturing facilities.

Regulators Hit Back at Assertions

FDA's Assistant Commissioner for Legislation, Jeanne Ireland, fired back in a letter sent 23 July to Rep. Elijiah Cummings (D-MD), the House Oversight and Government Reform Committee's ranking Democrat.

While the agency maintained that it "takes very seriously" the issue of drug shortages, it was adamant the causes of the shortages "live largely outside of FDA's purview."

"Contrary to the conclusion reached in the Report, FDA is not the root cause of this serious public health problem," FDA wrote. "In recent years, more than half of all drug shortages were related to manufacturing production problems, including quality-related issues and delays. The remained of the shortages was caused by business decisions to discontinue certain products, difficulty obtaining raw materials, loss of manufacturing sites, increased demand, and component problems."

Ireland, was also quick to pin responsibility for manufacturing failures on industry. "It is the manufacturer's responsibility to ensure that its products are safe, effective and of high quality," wrote Ireland. "When products manufacture under problematic manufacturing conditions pose a safety threat to patients-such as glass shards or metal shavings in vials of injectable drug products or fungal contamination of the product-manufacturers generally must stop production to resolve the problem before resuming manufacturing and distribution."

FDA: We're 'Not the Root Cause' of Shortages

"FDA alone cannot solve the drug shortage crisis," Ireland added.

Which isn't to say the agency isn't trying. Ireland cited FDA's actions in trying to resolve drug shortages, stating regulators averted 195 drug shortages in 2011 and have already been successful in averting more than 90 shortages in 2012.

Ireland also hit back directly at legislators' assertions, saying "it was the manufacturers who made the determination to stop producing drugs."

"FDA did not require the firms to shut down and even worked with each of them to try to avoid a shutdown, offering assistance to help assess and address manufacturing and quality concerns," wrote Ireland. Still, the deficiencies found at four manufacturing facilities-owned by Teva, Ben Venue Labs/Bedford Labs, Hospira and Sandoz, respectively-were not trifling. Among the alleged violations found by FDA were the presence of endotoxins, glass and metal particulate contamination, aseptic manufacturing and the formation of crystals in injectable solutions.

Ireland also brushed off legislative concerns that FDA was over-reaching its historical inspection trends. "[There] have been no recent changes in current good manufacturing practice standards, and no evidence of excessive enforcement actions related to manufacturing issues that could cause drug shortages," wrote Ireland. Even if they had increased, she said, industry problems separate and apart of quality deficiencies constituted "nearly 70% "of all issues contributing to drug shortages.

The real culprit in the rise of FDA warning letters, said Ireland, was the launch of the new Center for Tobacco products (CTP), which was responsible for 1,040 Warning Letters in 2011-"60% of all Warning letters that year."

"To summarize, the data clearly indicate that the number of Warning letters relevant to drug products has not increased radically, as the report suggests," concluded Ireland. "They are not the root cause of the recent increase in drug shortages."


Read more:

CNN - Is the FDA to blame for drug shortages?


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