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   July 2018

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

 Industry Insights

Talk This Way, Pt. 2: FDA Issues Final Guidances on Medical Product Communications
Alan G. Minsk and Elizabeth A. Mulkey
Once again channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric, “Talk This Way,” the Food and Drug Administration has issued two final guidance documents on medical product communications. These final guidances, issued in June 2018, address medical product communications that are consistent with the approved labeling, as well as communications with payors and formulary committees. These guidances are largely consistent with the January 2017 draft guidances on the same topics, which we have written about previously. Rather than summarize these documents anew, we will provide our analysis of the significant changes from the draft to the final versions. 
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Words Are Very Unnecessary: FDA Issues Letter for Unlawful Video Interview
Alan G. Minsk and Genevieve M. Razick 

In its 1990 hit, “Enjoy The Silence,” Depeche Mode sings, “Words are very unnecessary, they can only do harm.” The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 (also referred to as a Notice of Violation), informing a drug company that the statements made in a direct-to-consumer (DTC) video of an interview that featured paid and trained company spokespeople (here, a physician and the physician’s patient) were unlawful. 
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Who Me? Yes, You. Couldn’t Be. Then Who?: FDA Reinforces That Contract Manufacturers Can’t Delegate Away Regulatory Responsibilities
By: Alan G. Minsk

When my children were younger, we played a little game about “who took the cookie from the cookie jar” – Who me? Yes, you. Couldn’t be. Then who? We’d turn to another family member and start the game all over again. (Apparently, this dates back to my wife’s childhood.) This memory came to mind when reviewing a Warning Letter, recently issued by the Food and Drug Administration, to a Chinese contract drug manufacturer. FDA reiterated that the company could not delegate away its regulatory obligations or point to others for compliance. More >

Money, Money, Money Always Sunny: FDA Issues Updated Draft Guidance on User Fee Waivers, Reductions, and Refunds
By: Alan G. Minsk and Alexander B. Foster 

On June 21, 2018, the Food and Drug Administration issued new guidance related to the Prescription Drug User Fee Act. The document, “Guidance for Industry: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products,” updates and supersedes previous guidance issued in September 2011. Industry should carefully review the guidance document, as it contains a number of significant changes to and clarifications of the now outdated 2011 guidance. FDA recommends that electronic or written comments be submitted by August 20, 2018. 
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California Passes Sweeping New Privacy Law Aimed at Protecting Consumers’ Personal Information
By: Montserrat C. Miller and Bradford J. Kelley 

On June 28, 2018, the California governor signed AB 375, the California Consumer Privacy Act of 2018 (“the CCPA” or “Act”), intended to protect the private data of consumers and effectively pushing down some of the toughest consumer privacy protections in the country. The CCPA contains sweeping new consumer privacy requirements and has significant implications for entities doing business in California. Although the new requirements do not go into effect until January 1, 2020, businesses should begin to prepare now to ensure that they will be in compliance with the new state law. More >

Senator McCaskill Introduces Bill to Amend Sunshine Law
Jennifer Downs Burgar and Genevieve M. Razick 

In June 2018, Senator Claire McCaskill (D-Mo.) introduced the Patient Advocacy Transparency Act of 2018 (the “Act”), which, if adopted, would amend the Physician Payment Sunshine Act (the “Sunshine Law”). The Sunshine Law requires reporting to the government about certain transfers of value from manufacturers of drugs and medical devices to physicians and teaching hospitals. The Centers for Medicare & Medicaid Services (CMS), makes this information public in a database called Open Payments. 
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Hospice and the Opioid Crisis: Pending Senate Legislation Would Allow Certain Hospice Employees to Assist with Controlled Substance Disposal
H. Carol Saul and Alexander B. Foster 

The U.S. Senate is continuing to ramp up efforts to address the opioid abuse crisis. As a part of that effort, on April 16, 2018, the Senate introduced S. 2680, the Opioid Crisis Response Act of 2018. The Bill is currently in the Senate Health, Education, Labor, and Pensions Committee. If enacted, the legislation could mark a shift in the way hospice providers are allowed to handle drug disposal after a patient death. 
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Upcoming Events 

AGG Partner Alan G. Minsk will speak at the FDA Boot Camp on "Promotion, Off-Label Communications, and First Amendment Concerns," on September 26 - 28, 2018 in Boston, MA.

This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2018. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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