Drugs

Hard for States to Meet Import Rules: Califf

In a wide-ranging interview with the NTD global television network, FDA commissioner Robert Califf said that it is very difficult for states to meet the criteria established by Congress to permit bulk drug importation from Canada. Asked whether he expected importation to gain traction now that the agency has approved Florida’s plan, Califf noted that the approval criteria are very strict and difficult to meet. He said states have trouble ensuring supply chain security and also establishing an adverse event reporting system that can meet FDA requirements. He also noted that once FDA approves a proposal, it is up to Canada to respond, and FDA has no control over what Canada will or will not permit.

On other topics, Califf:

said the agency’s top priorities for 2024 at the level of the Office of the Commissioner are misinformation, evidence-generation, the market failure that can accompany low prices for generic drugs, and rare diseases;
discussed issues with the Internet availability of compounded obesity drugs that may not meet the standards of branded drugs, creating an enforcement issue;
suggested FDA could use more authority to regulate compounded drugs that are sold online;
indicated that more drug shortages are caused by low prices rather than high prices;
said the problem of counterfeit drugs is much greater worldwide than anyone knows because it’s very difficult to obtain statistics on counterfeit drugs;
highlighted the need for more research into treatments for mental health and chronic lung disease; and
said that as FDA increases its inspections, more drug manufacturing issues are found that can lead to supply chain issues.

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