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Articles by Gary Rom
FTC Announces Inquiry into the Infant Formula Shortage
On May 24, 2022, the FTC announced a widespread inquiry into the ongoing infant formula shortage. The agency had been tasked by the White House with investigating any price gouging or unfair market practices in the industry.
China Publishes Final GB Standard on E-Cigarettes: The Basis for Product Compliance
Since we reported in December 2021 on some significant developments in China’s regulation of e-cigarettes (including the draft national standard on e-cigarettes) as well as in March 2022 on the finalized Management Rules for E-Cigarettes, China’s State Tobacco Monopoly Administration (STMA), also referred to as China National Tobacco Corporation (CNTC), has not only released the national Standard GB 41700-2022 on Electronic Cigarettes but also published further regulations detailing the...
Group Standards: An Often Overlooked Regulatory Pathway to Export Food to China
“What food standard do you rely on to legally export your food to China?” This is probably the first question that you will likely encounter when exporting and selling food in China. Why is it so important to know the answer to this question?
OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural Patients | JD Supra
In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were prescribed a cancer drug that the company manufactured.
OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural Patients
January 14, 2021 DOJ Brings First Criminal “No-Poach” and “Wage-Fixing” Prosecutions;... by: Joel Mitnick and Ngoc Pham Hulbig Legal Ramifications of Flouting Mask Rules by Members of Congress by: Carolyn Wheeler Action Items on Technology and Communication Policies in front of the... by: Christian T. Fjeld and Christopher Harvie COVID-19: Comfort Zones - Overview of Business and Social... by: Kathleen M. Hamann and Suzanne King OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment...
Did the OIG Just End In-Person Speaker Programs? | JD Supra
On November 16, 2020, the Department of Health and Human Services, Office of Inspector General (OIG) published a Special Fraud Alert for Speaker Programs. The Special Fraud Alert "highlights some of the inherent fraud and abuse risks" related to company-sponsored speaker programs and provides examples of problematic speaker program characteristics that may render speaker program arrangements unlawful.
Pacira Pharmaceuticals Pays $3.5M to Settle Allegations of Using Grants as Kickbacks | JD Supra
On July 28, 2020, the Department of Justice (DOJ) announced a $3.5 million settlement to resolve allegations against Pacira Pharmaceuticals Inc. that it paid kickbacks to doctors in the form of “bogus” research grants to induce them to prescribe its analgesic EXPAREL. In the settlement agreement, the DOJ highlighted several problems with the grants.
FDA Amends Imported Non-NIOSH Approved Respirator EUA
Product safety and compliance are Heili Kim’s priorities. She blends inside knowledge from her role as regulatory counsel for the Food and Drug Administration (FDA) with business pragmatism and international perspective to guide food, dietary supplement, cosmetic and medical device clients on regulatory issues and advertising. She seeks to understand each client’s risk tolerance, objectives and goals to provide client-focused advice that will help the company thrive.
FDA Issues EUA to Increase Availability of Non-Surgical Gowns and Other Apparel | JD Supra
On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by health care personnel (HCPs) as personal protective equipment (PPE) for use in health care settings. FDA intends for the EUA to increase the availability of currently marketed and new non-surgical gowns and other apparel for a medical purpose during the COVID-19 pandemic.
FDA Revises EUA Criteria for Respirators Manufactured in China | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
FDA Revises EUA Criteria for Respirators Manufactured in China
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FDA Grants EUA for General Purpose Face Masks and Continues to Address PPE Shortage | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
FDA Opens Door to Respirators From Chinese Manufacturers, Revises Respirator Enforcement Policy | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
FDA Eases Regulations On Face Masks And Respirators During COVID-19 Pandemic | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Run a Compliant Speaker Program, Avoid Costly Penalties and Criminal Prosecution
By Gary Rom and Nicholas A. Klinefeldt You’ve likely heard of the $225 million global resolution opioid manufacturer Insys Therapeutics reached with the Department of Justice (DOJ) on June 5, 2019 to settle misconduct charges stemming from its speaker program practices. You’ve also likely thought that your company would never engage in the same behavior.
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