Reed Smith partner Kevin Madagan and associate Julia Lake will return for a second year to help lead a four-hour “Ad Promo Primer” at the Drug Information Association (DIA)’s “Advertising and Promotion Regulatory Affairs Conference,” which will be held virtually May 18-20, 2020. In addition, Kevin, a member of this year’s planning committee, will be leading a DIA discussion about pricing disclosures and communications.…

California Governor Gavin Newsom’s Executive Order N-43-20 (the Order), which went into effect on April 3, 2020, relaxes various telehealth reporting requirements, penalties, and enforcements otherwise imposed under state laws, including those associated with unauthorized access and disclosure of personal information through telehealth mediums.  The Order acknowledged that telehealth services may help reduce the spread of COVID-19, and strict compliance with certain state telehealth requirements would otherwise “prevent, hinder, or delay appropriate actions to prevent…

Pharmaceutical manufacturers, as well as other companies affected by or included in changes to pharmaceutical supply chains, are invited to join us tomorrow, April 7, for a complimentary webinar focused on current issues facing the global pharmaceutical supply chain. Reed Smith partners J.P. Duffy, Iqbal Hussain, and John Ellison will offer an engaging discussion on: The steps that companies need to take now given the potential for international arbitration claims to arise…

The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales. A team of Reed Smith life sciences and health care lawyers, including Scot T. Hasselman, Robert J. Hill, Carol Colborn Loepere, Kevin M. Madagan, Paul W. Pitts, James F. Segroves, Nicole J. Aiken-Shaban, Julia Krebs-Markrich, Debra…

The Telephone Consumer Protection Act (the TCPA) restricts telemarketing and the use of automated telephone equipment for phone calls, faxes, and text messages. In an effort to ease restrictions in light of the COVID-19 outbreak, the Federal Communications Commission (FCC) has issued guidance clarifying that informational calls that are directly related to the imminent health or safety risk arising out of the COVID-19 outbreak and made by certain types of callers are exempt from the…

Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an example, nonurgent spine and orthopedic implants (such as hip and knee replacements and elective spine surgeries) in healthy patients were…

If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation. This recommendation is designed to accelerate the time to market for these products, provided that safety is not compromised. For more information on the recommendation and how it contrasts with the typical steps to commercialize…