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

• Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection
• Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers
• What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion
• Update on Life Sciences Exports to Iran and Sudan
• Tenet Healthcare Will Pay $513 Million To Resolve Criminal Charges and Civil Claims
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection
By: Alan G. Minsk

In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an Import Alert, not allowing the company’s products to be imported into the United States. Tom Petty and the Heartbreakers’ 1985 hit, “Don’t Come Around Here No More,” and the weird Alison in Wonderland video come to mind. More >

Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers
By: Elizabeth A. Mulkey and Kelley C. Nduom

Life sciences companies regularly review their labeling and promotional materials to ensure compliance with Food and Drug Administration requirements. FDA makes its Warning Letters publicly available, and failure to correct unapproved, false, or misleading promotional materials can carry additional consequences. However, the Federal Trade Commission also reviews advertising for certain products, and consent orders by the Federal Trade Commission may be accompanied by serious financial penalties. This Bulletin is not intended to be a comprehensive look at FTC authority and actions, but we have provided a brief overview because we frequently see clients focus solely on FDA compliance when reviewing promotional materials. More > 

MEDICAL DEVICES

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion
By: Alan G. Minsk and Kelley C. Nduom

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its authority to proceed against unlawful promotion. In the medical device realm, manufacturers of devices that require 510(k) premarket notification submissions must take care to ensure that claims remain within the bounds of the product’s regulatory classification. A recent Warning Letter issued to a medical device company illustrates this point. More >

NEWS FROM WASHINGTON

Update on Life Sciences Exports to Iran and Sudan
By: Michael E. Burke

On September 28, the Office of Foreign Assets Control (OFAC) at the U.S. Department of the Treasury issued its Biennial Report of Licensing Activities Pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000, detailing its licensing activities for exports of medicine and medical devices to Iran and Sudan under that statute. The Report illuminates OFAC’s process for reviewing, and potentially approving, export license applications filed by U.S. exporters—particularly life sciences companies—for specific exports to Iran and Sudan. More >

Tenet Healthcare Will Pay $513 Million To Resolve Criminal Charges and Civil Claims
By: Sara M. Lord

Tenet Healthcare Corporation, an investor-owned healthcare services company based in Texas, and two of its Atlanta-based subsidiaries have entered into an agreement with the government to resolve criminal charges and civil claims stemming from a scheme to defraud the United States and to violate the Anti-Kickback Statute (AKS). Under the agreement, which was announced on October 3, 2016, Tenet will pay $513 million to settle the criminal charges and False Claims Act (FCA) claims, which are based on the unlawful referral of 20,000 Medicaid patients to Tenet hospitals.The case is significant because Tenet was under a corporate integrity agreement (CIA) from an earlier FCA case, and the criminal charges include allegations that the company’s executives falsely certified that the company was in compliance with the CIA while the unlawful scheme was in effect. More >

AGG Partners Author Chapter on Interacting With FDA

AGG Attorneys William H. Kitchens and Alan G. Minsk have been asked to contribute to the newest edition of the Practicing Law Institute's Medical Devices Law and Regulation Answer Book. Messrs. Kitchens and Minsk will update their chapter on "Interacting with FDA."

AGG Attorneys Published in Regulatory Focus

AGG Attorneys Alan G. Minsk and Kelley C. Nduom published the article “Do Recent First Amendment Court Developments Deal a Blow to the Government?” in the September edition of Regulatory Focus. The article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. More >

AGG Partner Alan Minsk will be giving an in-house talk to a pharmaceutical company client on FDA regulation of pre-approval discussions on November 1, 2016, in San Diego, CA. 

AGG Partner Alan Minsk will be speaking on medical device promotion from a regulatory science perspective at the UGA Medical Device Regulations Conference on November 1, 2016, in Athens, GA.