Drugs

Senate Amendment Seeks to Block Illicit Drug Imports

U.S. senators Ted Budd (R-NC) and Martin Heinrich (D-NM) have introduced a bipartisan amendment to FDA’s spending bill to strengthen the agency’s ability to prevent illicit pharmaceuticals and active pharmaceutical ingredients from entering the U.S., particularly from unregistered manufacturing facilities in China. “These illicit products, which include unregulated versions of ingredients used in name-brand GLP-1 medicines, are often produced in facilities in China that are not always registered with the FDA and pose serious risks to American consumers, with sometimes fatal consequences,” Budd says in a press release.

The amendment builds on a bipartisan letter, orchestrated by Rep. Richard Hudson (R-NC), which called on FDA commissioner Marty Makary to take immediate action against the growing threat of counterfeit anti-obesity medications (see earlier story).

Under the amendment, FDA would be empowered to use its full enforcement and regulatory authority to block the importation of illicit drugs. Potential actions include rejecting entry at U.S. borders, sending Warning Letters to foreign suppliers, and pursuing civil enforcement actions.

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

Read more

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