Category: Pharmaceutical Pricing

Drug Price Transparency Bill Enacted in Oregon

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers to report by March 31st each year information regarding each prescription drug for which: (i) the price was $100 or more for a one-month supply or for a course of treatment […]

Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals directed at lowering the cost of prescription drugs. These proposals are presented across the Budget volumes that reflect the Administration’s policy and fiscal priorities. Since many of these proposals require  Congressional […]

OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory Opinion Rescission

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP failed to fully, completely and accurately disclose all relevant and material facts to the OIG and failed […]

California Governor Signs Drug Price Reporting Bill

California Governor Jerry Brown signed S.B. 17 into law on Monday. As we reported when S.B. 17 was sent for Governor Brown’s signature, the law requires manufacturers of prescription drugs with a wholesale acquisition cost (WAC) of more than $40 to give 60 days’ notice of any increase in WAC […]

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

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 […]

California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers related to certain price increases of some already marketed drugs and the introduction of new drugs onto the […]

User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization.  The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in […]