All posts by Amy N. Westergren

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 […]

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 […]

Maryland Enacts Landmark Drug Price Gouging Legislation; Nevada Governor Considers Drug Pricing Bill

Maryland became the first state to enact legislation that outlaws “price gouging” in the generic drug market. H.B. 631, enacted on May 27, 2017 (the “Act”), has two components: (1) a prohibition on price gouging; and (2) a mechanism for reporting, investigating, and penalizing price gouging in the state’s Medicaid […]

Compliance Date for Drug Supply Chain Security Act Serialization and Verification Requirements Quickly Approaching

Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable entities in the drug supply chain to exchange information about products at the package level. Product identifiers, including Standardized Numerical […]

New Mexico Poised to Add the ‘Data Breach Notification Act’ to the Patchwork of State-Level Data Privacy Laws

The New Mexico Legislature passed the ‘Data Breach Notification Act’ (the Act) on March 15. The Act is now with Governor Susana Martinez who has 20 days from the date the Act was passed to sign it into law. If enacted, the Act would require a person, other than a […]

The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB Act) by a vote of 240 to 185, split mostly along party lines. If passed by the U.S. Senate and signed by President Trump, the SCRUB Act would […]

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures […]