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Regulatory Focus™ > News Articles > 2019 > 6 > House Committee Questions FDA on Foreign Drug Manufacturing Inspections

House Committee Questions FDA on Foreign Drug Manufacturing Inspections

Posted 28 June 2019 | By Zachary Brennan 

House Committee Questions FDA on Foreign Drug Manufacturing Inspections

As the US Food and Drug Administration (FDA) continues to recall contaminated blood pressure drugs made in foreign facilities, the House Energy & Commerce (E&C) Committee on Friday sent a letter to acting FDA Commissioner Ned Sharpless questioning the agency’s work overseas.

“We remain concerned about whether FDA has the resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” Chairman Frank Pallone (D-NJ), Ranking Member Greg Walden (R-OR) and other congressmen wrote.

They sought the most recent FDA data on inspections and unredacted Form 483s and other inspection reports from facilities linked to the sartan recalls.

The congressmen also sent a letter to the US Government and Accountability Office (GAO) on Friday, asking for a review of FDA’s drug inspection program.

The call to GAO included a request to look into FDA’s high-risk inspection selection process, the quality of data FDA relies on to select establishments for inspection, as well as the number of foreign sites subject to inspection and the frequency with which FDA inspects such sites, as well as other information.

The E&C committee leaders also point to two recent Bloomberg articles (one on China and the tainted blood pressure medicines and another on generic drug manufacturing) that found a decline in FDA’s foreign drug manufacturing inspections in 2017 and 2018. The articles also highlighted how FDA employees and field staff may disagree on violations found during the foreign inspections.

A recent report from FDA’s Office of Pharmaceutical Quality showed that 70% of drug manufacturers registered with FDA in FY2018 were based in the US, India, China, South Korea and Germany.

“Recall rates have generally held steady over the past five years and appear specific to incidents,” FDA said, citing the high rate of recalls for angiotensin II receptor blockers (ARBs) linked to nitrosamine impurities in FY2018 and FY2019. FDA pointed out that while the average inspection score for ARB manufacturing sites was 7.4 in FY2018, that figure does not include more recent inspections prompted by the discovery of the impurities.

The report also noted that FDA de-registered a large number of manufacturing sites in Asia in FY2018 as those sites did not manufacture any products intended for the US market, including 110 sites in South Korea.

And although FDA does not have more than 20 in-country employees in India or China, an FDA spokesperson previously told Focus: “Inspections of manufacturing facilities in other countries may be conducted by staff in foreign offices, those on temporary duty assignments, or staff that travel internationally to conduct the inspection. Currently there are a total of 255 investigators aligned to the drug program with 12 of those investigators currently on the foreign cadre.”

House E&C Letters

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