All posts by Amy N. Westergren

New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties

On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]

***UPDATED*** Senate ‘Right to Try’ Bill Under Consideration in the House of Representatives

***6/8/18 Update*** President Trump signed S. 204, now Public Law No: 115-173, into law on May 30th. ***5/23/18 Update*** The House passed S. 204 on Tuesday in a 250-169 vote in favor of the measure. The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right […]

GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and integrity agreements (collectively, “Agreements”) entered into by the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”) with entities subject to HHS-OIG’s permissive exclusion authority. The […]

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 […]