Drugs

FDA Signs MOU on Stopping Products at Mail Facilities

FDA commissioner Stephen Hahn says that the agency, the U.S. Customs and Border Protection (CBP)and the U.S. Immigration and Customs Enforcement have signed a memorandum of understanding (MOU) to stop harmful products that pose a threat to public health and attempt to enter the U.S. through international mail facilities (IMFs). “The MOU will maximize inspection and detection capabilities in order to prevent this illegal activity,” an agency notice says.

The three agencies have agreed to partner in joint operations to target illicit opioids and other unapproved or unlawful drugs, medical devices and dietary supplements regulated under the Federal Food, Drug, and Cosmetic Act. They will also look to intercept fraudulent, counterfeit or illegitimate Covid-19 products that may pose risks to public health. “Additionally, the agencies will work to coordinate ongoing activities through collaborative information sharing, shared facilities, and future coordinated operations,” the notice says.

FDA and CBP signed a letter of intent 4/2019, to maximize inspection and detection capabilities at the IMFs. Now, under the MOU, the agencies will expand the types of information and how that information is shared among them to quickly and effectively identify trends in incoming violative packages. “This collaboration involves sharing of both general and specific data points, which can be used to target impending product entries and to inform future enforcement strategies,” FDA says. “An additional focus of this effort will be coordinating shared space as well as increased scientific presence at high-volume IMF locations, helping to facilitate and support real-time entry decisions and increased data sharing.”

Since 4/2016, FDA has destroyed more than 12.9 million capsules/tablets/pieces – weighing over 41.2 tons. “The destruction of almost 13 million violative drug units by the FDA represents a key component of the agency’s public health mission, as these potentially dangerous drugs were destined for over 31,000 U.S. consumers,” the agency says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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