Drugs

FDA Should Facilitate Info-Sharing: Pitts

Former FDA associate commissioner Peter Pitts says the agency should facilitate the exchange of truthful and non-misleading information between doctors and drug companies so that doctors would be better able to prescribe medications off-label to help their patients. Writing online for The Hill, Pitts says doctors currently make off-label prescribing decisions based on anecdotal evidence, since they have no access to drug companies’ clinical trial data. “If FDA were to permit greater information sharing,” he writes, “it would enable doctors to treat patients more effectively.”

While companies could seek agency approval for additional indications, Pitts says, the process is time intensive and costly, and often the cost of reapproving a drug is greater than the profits the approval would generate.

“FDA should, of course, impose requirements on this information sharing,” the article concludes. “For instance, if the information comes from a clinical trial, drug companies should detail the trial’s sample size, limitations, and methodology. If it comes from physicians, they should describe patients’ conditions and detail how the drug affected them. These requirements would ensure that the information is clear and accurate. But it also would ensure that doctors have the most up-to-date information on a drug and the illnesses it can treat. Off-label prescribing has already saved thousands of lives. FDA ought to make it easier for doctors and patients to make the most informed treatment decisions possible.”

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