As valsartan recall persists, FDA touts facility inspection transparency
- The Food and Drug Administration released Wednesday an internal document showing how the regulator prioritizes manufacturing facilities for which it will conduct inspections.
- The agency also updated its inspections classifications database to provide more recent agency reports. It will now also add inspection reports from certain foreign regulatory authorities in the database, in addition to its own.
- "We'll continue to take new steps to address the challenges posed by a globalized drug supply chain," FDA Commissioner Scott Gottlieb said in a Sept. 5 statement. "These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products sold in the U.S. regardless of where a drug is manufactured."
The lengthy statement from Gottlieb, surpassing 1,600 words in total, came as the agency is conducting an extensive investigation into the blood pressure medication valsartan. More than half of all valsartan products are now under recall, the agency announced a week ago, and more may see the same fate.
The Sept. 5 release appears to be an attempt to show transparency in how the agency handles inspections.
Since the early 2000s, drug manufacturing has become increasingly globalized. The FDA shifted to a risk-based approach in the 2005 fiscal year, and in 2012 a law (FDASIA) required the agency to inspect both domestic and foreign drug establishments, taking into consideration "known safety risks."
For the 2017 fiscal year, the FDA inspected 5,063 pharmaceutical sites with about 60% of those being foreign-based.
The newly released seven-page document outlines the risk factors FDA uses in prioritizing plant inspections, including the establishment's compliance and recall history, the inherent risk of the manufactured drug and the frequency and history of previous inspections.
"We need to make sure that our inspections are prioritized based on potential risks to patients, and that we're using our resources efficiently," Gottlieb said.
The FDA also changed its field organization last year to shift from a geographically-based approach to basing resources around areas of specialization.
Finally, the announcement trumpeted the inspections classifications database, which was recently updated. Nearly 10,000 records have been posted in 2018. Gottlieb said it now incorporates some foreign regulatory agency inspection reports.
"FDA carried out these updates well ahead of our scheduled commitment under the reauthorized Generic Drug User Fee Amendments (GDUFA II) to perform the updates by 2019," Gottlieb said. "The agency went beyond the commitment to provide timely updates regarding generic drug manufacturing facilities – as the database is updated every 30 days with classifications for inspections for all FDA regulated products, not just generic drugs."