AdvaMed Code of Ethics Updated Effective January 1, 2020

The Advanced Medical Technology Association (AdvaMed) announced earlier this month the availability of an updated Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code). The updated AdvaMed Code becomes effective January 1, 2020. According to AdvaMed, the AdvaMed Code was updated to make examples current, enhance user-friendliness, and address the evolving nature […]

340B Drug Program Price Ceiling and Penalties Moved Up To Start January 1st

On November 30, 2018, the Department of Health and Human Services (HHS) issued a final rule that puts in effect January 1, 2019, rather than July 1, 2019 as previously announced significant changes to the 340B program including a ceiling price on how much drug manufactures can charge hospitals who […]

OIG Provides Strong Rebuke of Pharmaceutical Free Drug Program

On November 16, 2018, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-14 regarding a proposed free drug program (“Proposed Arrangement”). Under the Proposed Arrangement, a pharmaceutical manufacturer (“Manufacturer”) will give free drug product (“Drug”) to hospitals for inpatient use to […]

Federal Sunshine Act Reporting Requirements Expanded to Other Prescribers

Currently, the federal Physician Payments Sunshine Act (Sunshine Act) requires certain manufacturers of drugs, biologics, medical devices and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (Applicable Manufacturers) to report annually to the Centers for Medicare and Medicaid Services (CMS) certain payments and transfers […]

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 […]

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

***Further update – Federal Court Vacates Rule*** Yesterday, U.S. District Court for the D.C. Circuit Judge Amit Mehta invalidated the final rule.  In ruling on the merits, Judge Mehta said the Department of Health and Human Services went beyond its rulemaking authority.   Specifically the ruling states, “[n]either the Act’s text, structure, […]

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 […]