Drugs

Reopen FDA San Juan Lab: Representatives

Reps. Alexandria Ocasio-Cortez (D-NY) and Nydia Velázquez (D-NY) are calling on HHS secretary Robert F. Kennedy, Jr., to reverse the reduction in force that forced the FDA San Juan, Puerto Rico, medical products laboratory to close. In a statement (contains a link to their letter to Kennedy), the representatives say the lab “is one of the few FDA owned and operated facilities specializing in pharmaceutical drug analysis. It has evaluated and led to removal of thousands of adulterated products from the market that otherwise would have exposed American consumers to unsafe products.”

The statement says the lab’s 20 employees all received a reduction in force notice and the facility has ceased operations. “Shutting down this laboratory is against your commitment to protect ‘essential services’ and ‘frontline jobs’ as doing so jeopardizes the safety of millions of Americans by weakening FDA’s ability to detect contaminated pharmaceuticals, respond to health emergencies, and safeguard national security,” the letter to Kennedy says.

Ocasio-Cortez and Velázquez ask Kennedy to tell them:

what criteria HHS used to select the lab for a reduction in force and shut-down;
whether FDA has assessed how the lab closure might affect public health emergency preparedness and national security;
the contingency plans FDA has in place to address potential delays in drug product testing and approvals and how FDA intends to ensure the timely analysis of drug samples previously completed at this facility;
how FDA will ensure that the quality and regulatory oversight standards for drug products are maintained or improved despite closing the lab; and
what data or financial analysis supports the claimed cost savings from closing the lab and how that was weighed against the public health impact.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome