Drugs

PA Docs Want FDA Marijuana Research

The Pennsylvania Medical Society (PMS) is asking FDA to support research leading to development of treatment options with medical marijuana. In a letter to FDA acting commissioner Stephen Ostroff, the society also urges the agency to reschedule marijuana from a Schedule 1 to a Schedule 2 substance to facilitate research across the country. The request follows a Drug Enforcement Administration announcement that requirements on FDA-approved clinical trials on cannabis-derived research will be relaxed.

“Pennsylvania physicians overwhelmingly want thorough and complete FDA-approved research on marijuana for medical use because there are so many unanswered questions about its use,” says PMS president Scott Shapiro. “In sending this letter to FDA, we’re going to do everything possible on behalf of patients and physicians to push for such research.”

Shapiro says that additional research is needed due to the large number of compounds found in marijuana, inconsistency among plants, and unknown factors. He says that pushing for research instead of outright legalization would help build a body of evidence that potentially could help more patients.

“Physicians are held to a standard for all medical conditions to prescribe treatments, medications, or therapies where peer-reviewed studies clearly demonstrate safety and efficacy, whether it’s treatment for heart disease, cancer, diabetes, or conditions commonly associated with using cannabis, to make sure we don’t inadvertently cause harm to our patients,” he says. “Physicians aren’t running out in large numbers and prescribing marijuana for medical use … likely because they have too many questions and want to see FDA-approved clinical research first.”

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