Manufacturers, Pharmaceutical Industry, HCEI

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Skadden, Arps, Slate, Meagher & Flom LLP on 1/6/2023

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

McDermott Will & Emery on 4/1/2020

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

FDA and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

King & Spalding on 6/21/2018

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

FDA Guidance on HCEI and Communications to Payors of Unapproved Products and Uses

Holland & Knight LLP on 6/15/2018

On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers"...more

FDA Issues Draft Guidance on Payor Communications

McDermott Will & Emery on 2/2/2017

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper on 1/31/2017

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more