Drugs

Stakeholders Question Healthcare Professional Survey

Three stakeholders are raising questions about proposed FDA research surveying healthcare professionals on prescription drug promotion. Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency has not followed Paperwork Reduction Act (PRA) procedures that require it to provide adequate means to request and obtain a copy of the survey. “Before FDA can go forward with its survey,” PhRMA says, “the PRA requires FDA to issue a new 60-day notice that complies with the PRA and applicable regulations. The new notice should provide an adequate mechanism for the public to obtain without charge the actual survey and its related instructions, and not just the general summary of its research goals in the Federal Register.”

PhRMA also complains that the proposed survey duplicates information otherwise reasonably accessible to the agency. If FDA goes forward with its proposal, the trade group says, it should modify the survey’s questions on opioid issues. Rather than only inquiring about abuse-deterrent formulations, it says, FDA should also ask about alternatives to opioids and other tools to address the opioid crisis. PhRMA also offers specific comments on the proposed survey questions to provide clarity and better align the questions with the research’s stated purpose.

UnitedHealth Group asks FDA to consider including survey questions on how promotional materials and procedures address abuse-deterrence formulations for opioid products. It also suggests the inclusion of questions related to marketing of abuse-deterrent formulations of opioid products to ensure that providers understand that: abuse-deterrent formulated products have not proven any less addictive that standard formulations, the potential for patient harm from dose-dependent misuse of abuse-deterrent formulated products remains, potential methods for defeating the “tamper-proof” formulation still exist, and there are effective ways to protect against accidental ingestion of the drug or theft by others.

Lilly provides comments on the study methodology and objectives and also on the study questionnaire.

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

Read more

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