Author: Edwin N. McIntosh

Edwin N. McIntosh

Ed helps a variety of health care providers address complex regulatory issues, strategic acquisitions, affiliation and contractual agreements.

He represents large metropolitan hospitals as well as critical access hospitals, retirement communities and physician groups, on a broad range of health, employment, regulatory and litigation matters. He has represented healthcare providers in the development of co-management agreements, acquisition of physician practices, and medical director agreements.

View Full Bio on Dorsey

President Trump Signs Federal “Gag Order” Pharmacy Bills

Edwin N. McIntosh

Today, President Trump signed into law two bills that have gained bipartisan support including the “Know the Lowest Price Act of 2018” and the “Patient Right to Know Drug Prices Act”. Together, these two bills ban “gag order” clauses in contracts for Medicare and Medicare Advantage Beneficiaries and commercial employer-based and individual insurance policies. “Gag...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent with the FDA-Required Labeling

Edwin N. McIntosh

On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling” (the “Guidance”), explains the FDA’s views on firms’ communication of information that is not contained in the FDA-required...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part I – Health Care Economic Information and Unapproved Products/Use Communications with Payors

Edwin N. McIntosh

On June 12, the FDA issued guidance that clarifies its recommendations for certain medical product communications. The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (the “Guidance”), provides answers to common questions about the communications between medical product manufactures, packers, and distributors (“firms”), and insurance companies,...

Creation of Health Care Fraud Unit in Chicago and Recent “Takedown” Shows Continued Emphasis on Health Care Fraud Enforcement

Edwin N. McIntosh

On July 18, 2017, the United States Attorney’s Office for the Northern District of Illinois announced that it was creating a new unit located in Chicago within the office’s Criminal Division dedicated to prosecuting criminal health care fraud (the Health Care Fraud Unit). The office explained that it expected the unit, which will include five...

The Changing Landscape of the Fight Against Opioid and Heroin Addiction and the Availability of Naloxone

Edwin N. McIntosh

In recent months, the Obama administration and many health and pharmaceutical players at the state and local levels have focused their attention on the national opioid epidemic. Based on recent findings from the National Center for Injury Prevention and Control, approximately 40 Americans die each day from overdoses involving prescription opioids. Additionally, according to the...