Is the FDA Going to Increase On-Site Inspections of Foreign GMP Manufacturers?
(Thursday, February 8, 2024) This week the US House of Representatives held a hearing on the lack of foreign on-site GMP inspections by the FDA where representatives from the GAO and other stakeholders including a “star witness” from India, presented their concerns about the quality of drugs imported into the US. The speakers and the committee members seemed to pressure the FDA to increase foreign inspections, but would the FDA do that? Almost all the generic drugs and more than half of the new drugs are imported into the US from manufacturing sites located in foreign countries, most prominently India and China. Compared to the manufacturing sites located in the US, the foreign sites are harder for the FDA to audit for logistical, legal, financial, and other practical reasons. FDA has one office each in India and China that coordinates inspections within the respective country. These offices are grossly understaffed and are unable to conduct robust on-site inspections in their host countries. Over the last 2 decades, these offices have relied on the quality checks at the ports of entry in the US to target inspectional resources to the most egregious violators, reports of safety issues related to imported drugs, and targeted on-site inspections by the FDA inspectors. According to the FDA, despite the limited resources, it can adequately protect the US supply chain. Before the pandemic, FDA executives presented a robust rebuttal of concerns raised by non-FDA parties about the quality of drugs imported from India. During the pandemic, when the FDA was unable to conduct on-site inspections in foreign countries, it used that as an opportunity to enhance its remote inspection practices. There have been FDA 483s and several Warning Letters to the manufacturers in India and China over the years but overall, there have not been any FDA-reported trends for these countries that would show the higher-than-average non-compliance issues at sites in India. If you ask the FDA, there is no cause for concern. However, that evidently does not satisfy the GAO, the US Congress, and a few other stakeholders. The challenge for the public is who to trust: the FDA? The politicians? Or the other witnesses at the hearing? From a legal perspective, all parties other than the FDA have only presented anecdotal evidence to support their concern. The one witness from India has not worked at any manufacturing facility in India or other places for more than 15 years and cannot be reasonably considered an expert on the current status of GMP compliance anywhere. It is easy to make generic claims such as “the companies in India have gotten smarter to evade inspections” when you don’t have to back it up with facts. Anecdotally, there have been no reports of US consumers being an additional risk from their generic drugs manufactured in India from the FDA or other independent sources. Doesn’t mean we should be complacent but that we don’t have a clear target for improvement. Other witnesses at the hearing presented concerns that appear too generic for the FDA to take any action. FDA has already responded to the GAO concerns. FDA did not attend the hearing citing a lack of formal request to attend from Congress but even if it had attended, there is no reason to think that FDA would have agreed with the concerns wholeheartedly and promised to do any different. Ironically, the FDA released a new Guidance around the same time as the Congressional hearing on remote inspections. It is safe to assume that the Congressional hearing this week would not be more than another note to file for the FDA. There were no specific directions issued to the FDA at the hearing. The overall conclusion was that it would be nice for the FDA to be able to conduct more foreign on-site unannounced inspections, but it does not have the resources to do that. For now, we will stay where we are about the foreign on-site inspections by the FDA: more remote, and targeted on-site inspections. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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