Drugs

DTC Guidance May Signal Enforcement Shift: Attorneys

Three Hogan Lovells attorneys say the FDA finalization of a 2018 draft guidance with recommendations on how companies can best present quantitative efficacy and risk information in direct-to-consumer (DTC) promotional materials may signal that the CDER Office of Prescription Drug Promotion (OPDP) “may be preparing to return to enforcement against promotional materials that it deems false or misleading.” In an online post, the attorneys list several recommendations from the original draft along with several that were added as the draft was finalized.

The post notes that the final guidance was issued within weeks of a proposed rule on Medication Guides that would significantly change the prescription drug labeling regulation to require that Rx drug and biological product applicants create a new Patient Medical Information form that is not false or misleading.

“It is fair to ask whether FDA’s prescription drug promotion office will become more active,” the attorneys write. “OPDP may be completing its research into which claims may mislead consumers and into how health care providers interpret those claims, and now moving into a new phase where it will use that research to inform its regulatory positions.”

The attorneys say that in the past drug and biotechnology manufacturers struggled to translate approved instructions for healthcare providers into patient-friendly language for patient brochures, DTC advertising, and direct-to-patient communication. They say companies will want to closely assess guidance and OPDP statements as new rules are crafted that sponsors must follow.

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