Drugs

Spanberger Wants More ADHD Drug Info

Rep. Abigail Spanberger (D-VA) is asking FDA and the Drug Enforcement Administration (DEA) to provide additional information on their work to end shortages of attention deficit hyperactivity disorder (ADHD) medications, including Adderall. A media statement says that while DEA has adjusted production quotas for certain ADHD medications and encouraged additional transparency from manufacturers, Spanberger continues to hear from Virginians who face difficulties in filling prescriptions more than two years since the drugs were first declared to be in shortage by FDA.

“While I appreciate the efforts from your agencies,” the representative wrote, “the shortage persists and more must be done to ensure patients can access the medications they need to function.”

She asked the agencies to provide answers to these questions:

an update on the implementation and effectiveness of DEA strategies to mitigate continuing drug shortages;
whether DEA will consider aggregate production quota adjustments for amphetamine mixed salts;
how FDA and DEA work with manufacturers of ADHD medications to address issues in fulfilling quotas; and
actions the agencies believe that Congress should take to support FDA and DEA in addressing and preventing the shortages.

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