Drugs

14 House Dems Want ADHD Drug Shortage Info

Rep. Abigail Spanberger (D-VA) and 14 other House Democrats are asking FDA and the Drug Enforcement Administration (DEA) for more information on their efforts to end the shortage of attention deficit hyperactivity disorder (ADHD) medications. In a statement (includes the text of the letter to the agencies), Spanberger and her colleagues say they asked FDA and DEA to provide more information to Congress and the American people on steps being taken to address the shortages. They also ask the agencies to work with manufacturers to mitigate future shortages.

The letters ask for answers to these questions:

is DEA considering increasing the aggregate production quota for amphetamine mixed salts as it did with methylphenidate (Janssen’s Concerta);
how the two agencies have worked with manufacturers of ADHD medications to address issues fulfilling quotas;
how DEA will implement lessons from the Covid-19 public health emergency into updated telemedicine prescribing rules;
the additional steps FDA and DEA are taking to address continuing shortages around ADHD medications and to provide necessary relief for patients across the county;
the steps FDA and DEA are taking to mitigate future shortages of ADHD medications; and
the actions Congress should take to support FDA and DEA in addressing and preventing these challenges.

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