Tag: BIO

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 […]

FDA Announces Critical Off-Label Forum for Drugs and Devices

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological […]

9th Circuit Upholds Alameda County Manufacturer-Funded Drug Disposal Ordinance

On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug disposal operations was constitutional.  The plaintiffs-appellants in Pharm. Research & Mfrs. of Am v. County of Alameda (9th Cir., […]

Sunshine Act Media Coverage and CMS’s Response Today

The Open Payments database has been live for a week now.  There has been media coverage, but most has not been the type that many expected.  The coverage to date has largely centered on the significant challenges associated with accessing and using the database.  For example: US News & World […]

Is CMS Feeling the Sunshine Heat? – Part 3

As we discussed in Part 1 and Part 2 of this ongoing story, the Centers for Medicare & Medicaid Services (CMS) has received significant criticism related to issues with the Open Payments database and its plans to release the information by the end of this month despite data concerns.  The latest development is that […]

Is CMS Feeling the Sunshine Heat?

As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group purchasing organizations (GPOs).  This data is scheduled for public release by CMS on September […]