Drugs

Concerns About Opioid Mail-Back Envelope Proposal

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA proposal to require manufacturers to provide mail-back envelopes and education on the safe disposal of opioid analgesics dispensed in an outpatient setting is well-intentioned but could inadvertently lead to increased opioid theft and diversion. PhRMA’s letter says the association believes current drug disposal options are sufficient. PhRMA also makes these points:

a wide range of options in addition to in-home disposal already exist, providing a range of options for consumers;
in-home disposal has the least harmful impact on the environment compared to other disposal approaches;
the potential increased risk for diversion created by a potential mail-back program far outweighs the potential benefit to consumers;
there is limited evidence to suggest that takeback programs meaningfully affect non-medical use or diversion in the home or that a mail-back program would yield different results;
PhRMA is concerned over the proliferation of various drug deactivation packets or pouches despite inadequate scientific or technical evidence of their effectiveness and insufficient research on ease of use from end-users compared to other approaches; and
the association supports efforts to increase education around the appropriate use of medicines as well as around the appropriate disposal of unused medicines.

In its letter, the National Association of Chain Drug Stores calls on FDA to “leverage its opioid analgesic risk evaluation and mitigation strategy to require opioid manufacturers to fund and provide for a variety of disposal solutions that healthcare providers (including but not limited to pharmacies) and other stakeholders could voluntarily make available to patients.” The association also provides additional ideas for modifying the REMS.

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