Drugs

NJ Proposes Limits on Payments, Gifts to Prescribers

The New Jersey attorney general and Division of Consumer Affairs is taking comments on a proposed rule to limit payments and gifts from drug manufacturers to licensed providers who are authorized to prescribe medications. Attorney Serra Schlanger (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the proposal lists things that New Jersey prescribers could not accept and those gifts and payments they could accept.

“The rule would impose a limit of $10,000 per calendar year on the amount of compensation that a single prescriber may receive in the aggregate from all pharmaceutical manufacturers for speaking at promotional activities, participation on advisory boards, and consulting,” Schlanger writes. “Payment for speaking at continuing education events would not be subject to the $10,000 cap.”

She says the proposal is modeled on the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals, but includes certain limitations that are more stringent than that code.

Schlanger notes that the proposed rule would not specifically exempt compensation for serving as an investigator in a clinical trial or otherwise conducting bond fide research. Even if such research payments were considered “consulting arrangements,” she says, they would be subject to the $10,000 aggregate annual cap applicable to each prescriber.

State licensing boards would be empowered to take enforcement action against prescribers who accept prohibited gifts or payments from pharmaceutical manufacturers. “Although the proposed rule would not impose penalties on, or otherwise increase the state’s authority over, pharmaceutical manufacturers,” Schlanger concludes, “the limitations in the proposed rule could dramatically impact how manufacturers interact with prescribers in New Jersey.”

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