John Serio featured in The New York Times
3 April 2023 | Applicable law: US | 3 minute read
John Serio was recently featured in The New York Times article "Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person."
Numerous infections, some deadly, have been linked to eyedrops imported from India to the United States. The drops do not require a prescription and are believed to potentially expose consumers to a highly drug-resistant strain of bacteria that had not been previously detected in the United States. The bacteria has spread from person to person in a Connecticut long-term care facility, raising fears that it could continue to gain traction in the US population. The Food and Drug Administration (FDA), which is responsible for the regulation of over-the-counter products such as the eyedrops, had not inspected the factory prior to cases of the bacterial infection. The FDA does not require a pre-approval inspection of plants that manufacture over-the-counter medicine and has since visited the plant and ceased imports of the product.
John Serio, a partner in Withers' intellectual property team, provided his insight on the FDA's approach to over-the-counter products: "the F.D.A. uses a system that essentially lists a medication recipe. Companies can make the products without express agency approval but are expected to follow agency rules for manufacturing quality products." The FDA noted several issues with the manufacturing plant's sterile practices within their inspection report. John, whose experience with biotech and pharmaceutical matters has made him well acquainted with the FDA's policies and procedures, commented “if you’re not out there inspecting facilities, these sorts of problems will crop up because there’s no threat that if you’re out of compliance that the inspector will come knocking at your door."
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