Tag: marketing

Two Federal Transparency Bills Introduced in Congress

Two new federal bills have been introduced in Congress related to manufacturer transparency. Senate Bill 2891 (S. 2891), the Fighting the Opioid Epidemic with Sunshine Act of 2018, was recently introduced by Senators Grassley, Brown and Blumenthal. S. 2891 would amend the current Open Payments law to require annual reporting […]

Two Enacted State Laws Permit Truthful Off-Label Promotion

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]

Nevada Releases Procedures for Pharmaceutical Representative Registration

The Nevada Department of Health and Human Services (DHHS) recently released procedures related to pharmaceutical representative registration in response to Nevada SB 539. An overview of Nevada SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry, is available here. The procedures require registration by pharmaceutical representatives that physically […]

Pharmaceutical and Biotechnology Industry Representatives File Lawsuit Over Nevada’s Prescription Drug Transparency Bill *UPDATED*

On September 1, 2017, Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization (collectively “Plaintiffs”) filed a complaint (the “Lawsuit”) in the United States District Court for the District of Nevada, against Brian Sandoval, in his official capacity as the Governor of the State of Nevada, and Richard Whitley […]

Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit Organizations

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in adopting legislation aimed at addressing pharmaceutical price increases and other recent industry concerns. Diabetes Drug Pricing Reports February […]

West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP). This includes section 16-29H-8 of the Code, which requires prescription drug manufacturers and labelers to annually report advertising and promotion costs for the prior calendar […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]