Are FDA Inspections of Overseas Production Facilities a Thing or Not?

With the outbreak of potentially deadly transmittable infections from the bacterium P. aeruginosa apparently sparked by contaminated eye drops manufactured in India, we once again confront how dependent we are on health items (including ones that can kill or blind you) produced overseas in largely unregulated manufacturing facilities. And what did the FDA find when they found their way there? They found a facility grossly in violation of cleanliness standards.

We are talking about a treatment-resistant bacteria that can be spread person to person, rendering those in congregate living situations (think, nursing homes) particularly vulnerable to transmission. You can learn about the FDA’s foreign drug inspection program here. Mind you, this report predates the COVID pandemic, but the author is still crowing that roughly half of all previously never inspected facilities have now been inspected.

Fixing the Family Glitch

The final regulation is out from HHS attempting to fix what is know as “the family glitch” and giving a further 200,000 Americans opportunity access subsidized health insurance coverage through the exchanges. If you think about, it is amazing it took so long from the Affordable Care Act’s inception and implementation to address the fallout from allowing household family members to be within the definition of those eligible for exchange purchase because of unaffordability of employer offered family plan health insurance. In short, those opposing the fix maintain that the drafters meant those offered employer sponsored insurance that exceeds roughly 9.4 percent of their income for a family plan should seek publicly funded insurance, charity, or go without.

The Significance of the End of the COVID Emergency

The political maneuvering around declaring COVID over and done is absolutely fascinating. But, today, I am interested in the official end of the declaration of public health emergency by the federal government. So much hinges on the termination date: HIPAA requirement waivers; nursing home staffing standards waivers, are two that loom large. Today, I learned the official termination of the federal pronouncement of the public health emergency has been extended until January 1, 2023.