Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

• A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug
• Lawyers, Drugs, and Money – The Opioid Crisis Makes for Strange Bedfellows
• Ninth Circuit Holds that FDA Violations can Lead to FCA Liability
• Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse
• Update on Successes and Hurdles in Improving 340B Program Oversight
• Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes
• Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs

Industry Insights

PHARMACEUTICALS

A Rose by Any Other Name: Drug Claims Make Your Cosmetic a Drug
By: Deborah L. Livornese and Kalie E. Richardson

Last month, FDA district offices issued Warning Letters to two cosmetic companies for making claims that established their products as drugs. In finding that the products were new drugs requiring premarket approval, FDA highlighted both disease claims and claims about the therapeutic effect of certain ingredients. More >

Lawyers, Drugs, and Money – The Opioid Crisis Makes for Strange Bedfellows
By: Deborah L. Livornese 

It seems that almost every day there is a new development in the government’s response to the opioid crisis or opioid emergency. But it’s not only the government and healthcare providers that are considering novel approaches. At least one drug manufacturer has been reported to be taking its marketing directly to those in a position not to prescribe its product, but to mandate its use. And to paraphrase Warren Zevon, it brings together (former) lawyers, drugs and money. More >

Ninth Circuit Holds that FDA Violations can Lead to FCA Liability
By: Deborah L. Livornese and Kalie E. Richardson

On July 7, 2017, the Ninth Circuit Court of Appeals issued an opinion in United States ex rel. Campie v. Gilead Sciences, Inc., holding that violations of Food and Drug Administration (FDA) regulations could create liability under the False Claims Act (FCA). Relying on the Supreme Court’s June 2016 ruling in Universal Health Servs., Inc. v. United States (“Escobar”), the Ninth Circuit found that Gilead Sciences, Inc. (Gilead, a large drug manufacturer) had both factually and impliedly certified compliance with FDA regulations pertaining to its HIV antiretroviral drugs. Overturning the district court’s grant of Gilead’s motion to dismiss, the Court determined that pursuant to Escobar, Gilead’s alleged noncompliance with the relevant regulations, if proven, would have been material to the government’s decision to pay reimbursement claims related to the drugs. As such, said the Court, if the company had indeed failed to comply with applicable FDA regulations, such noncompliance could render its reimbursement claims “false” under the FCA. More >

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse
By: Deborah L. Livornese and Genevieve M. Razick

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The announcement follows DOJ’s recent significant enforcement activity in July 2017 to identify and prosecute more than 412 individuals involved in opioid-related health care fraud involving $1.3 billion in fraud-related schemes. More >

Update on Successes and Hurdles in Improving 340B Program Oversight
By: Neil W. Hoffman, Ph.D. and Kara G. Silverman

On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent weakness of federal 340B Drug Pricing Program (referred to as the “340B Program”) oversight, which is administered by the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (housed within the U.S. Department of Health and Human Services). In the most recent report, the GAO indicates that HRSA has had mix success in adopting GAO’s oversight recommendations. More >

MEDICAL DEVICES

Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes
By: Deborah L. Livornese and Alan G. Minsk 

In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from the Food and Drug Administration that seemingly surprises the client but, if the company had carefully read the agency’s correspondence or listened during a meeting or a telephone call, it would have seen the signs. More >

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs
By: Deborah L Livornese and Alexander B. Foster

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs. The new initiatives include the Digital Health Innovation Action Plan and Software Precertification Program. More >