Month: October 2018

Cooley Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

Biologic drug makers will soon have to alert the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement is part of the Patient Right to Know Drug Prices Act, which President Trump signed into […]

***Updated** HHS Releases Plan to Require Drug Makers to list prices on TV ads

***Update- Final rule released*** Yesterday HHS released the final rule which takes effect in 60 days.  The final rule made some technical changes and one notable change, that state law-based claims that depend “in whole or in part on any pricing statement required by this rule” are preempted.  Yesterday, the Department […]

PhRMA Releases Updated Guiding Principles on DTC Advertising

The Pharmaceutical Research and Manufacturers of America (PhRMA) released today updated Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines (Guiding Principles), which will be effective April 15, 2019. These Guiding Principles replace the prior version. Revisions to the Guiding Principles include a new principle 19 that all product-related direct to […]