Drugs

Califf: FDA’s Duty to OK Generic Opioids is a ‘Difficult Problem’

Is FDA looking for some wiggle room to skirt its obligation under current law to approve generic opioids in the face of unprecedented public alarm about the current abuse epidemic? Addressing the recent Rx Opioid and Drug Abuse Summit in Atlanta, FDA commissioner Robert Califf acknowledged calls for the agency to limit the number of opioids it approves. “But there are limits to what we can do under the current law,” he said. “Under the current law, FDA is obligated to approve an application for a generic drug unless the product fails to demonstrate bioequivalence to the innovator or it does not meet other standards. This is a difficult problem that we’ll be talking about more in the near future.”

In contrast, Califf said ensuring appropriate access to generic abuse-deterrent opioids is an important element in the agency’s broader strategy to help combat abuse. “We’ve noticed in prescribing patterns that abuse-deterrent formulations have not taken a large share of the market, perhaps in part due to the much higher cost without generic formulations on the market,” he said. “So the availability of less costly generic products has the potential to increase the use of abuse-deterrent formulations.”

Califf said that an “essential piece of developing new abuse deterrent products is having the necessary data on the impact of existing [abuse-deterrent formulation] ADF products. That’s why FDA has made the decision that all sponsors of brand name products with approved abuse-deterrent labeling must conduct long-term studies to assess their effectiveness in reducing abuse in practice. To generate further discussion and ideas on this topic that could lead to more effective ADFs, we have scheduled three advisory committee meetings on ADF opioids in May and June. You can see there will be plenty of opportunity for discussions, and we do seek your input and guidance on these 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