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

• Things That Make You Go Hmmm, Part II: Drug Company Plays Games with FDA to Delay Facility Inspection
• Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions
• Changes to Georgia's Prescription Drug Monitoring Program Await Governor’s Signature
• 340B Coalition Urges HHS to Implement Final Rule Regarding Ceiling Price and Manufacturer Civil Monetary Penalties
• Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New York Attorney General
• Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect
• Do You Want a “.health” Web Domain Name? Do You Want to Prevent Others from Using Your Trademark in a “.health” Web Domain Name?
• California Regents File State False Claims Act Case Against Healthcare Providers and Pharmacies for Allegedly Defrauding UC Student Health Insurance Plan
• HHS OCR Resumes HIPAA Enforcement Action Announcements: Four New Settlements and Penalties Totaling More than $5 million in a One Month Period
• Industry Activities and Recognition

PHARMACEUTICALS

Things That Make You Go Hmmm, Part II: Drug Company Plays Games with FDA to Delay Facility Inspection
By: Alan G. Minsk

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently say, “Hmmm.” I have always wanted to find a Part II story for my now-ten-year old daughter to avoid any sibling rivalry. The time has come. More >

Let’s Get Clinical: ClinicalTrials.gov Reporting Requirements Now in Effect
By: Deborah L. Livornese and Kalie E. Richardson

The compliance date for the Final Rule implementing the clinical trial reporting requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA), also known as FDAAA 801, arrived on April 18, 2017. The Final Rule implementing the statute came into effect almost ten years after the statutory requirements of FDAAA 801 were enacted. The Final Rule on Clinical Trial Registration and Results Information Submission was issued by the National Institutes of Health (NIH) and covers requirements for data that must be submitted to ClinicalTrials.gov. The data reporting requirements apply to sponsors, or, under certain circumstances described in the Final Rule, principal investigators, of certain clinical trials and postmarket surveillance required by FDA for drugs, biologics, and medical devices. This Bulletin provides a brief overview of what is considered an applicable clinical trial under the regulations, what data need to be submitted, and who is the responsible party. Sponsors with currently active clinical trials should ensure that they are in compliance with the Final Rule and evaluate existing clinical trials and new clinical trials going forward under the criteria described in the Final Rule. More > 

Money for Nothin': FDA's PDUFA Fee Waivers and Exemptions
By: Alan G. Minsk and Alexander B. Foster

Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human drug and biological products. Under PDUFA, there are three types of "user fees": application fees, establishment fees, and product fees. PDUFA also established a fee waiver program. Given the substantial savings resulting from a fee waiver, we are often asked to review applicability of the waiver to certain products. We have listed answers to some of the most common questions we receive regarding fee waivers. More >

340B Coalition Urges HHS to Implement Final Rule Regarding Ceiling Price and Manufacturer Civil Monetary Penalties 
By: Neil W. Hoffman

On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufacturers to civil monetary penalties for overcharging for 340B drugs. More >

Changes to Georgia's Prescription Drug Monitoring Program Await Governor’s Signature
By: Jennifer E. Tyler and Genevieve M. Razick

During the 2017-2018 Georgia General Assembly legislative session, the House and Senate voted to approve HB249, a bill that would make several changes to the Georgia Prescription Drug Monitoring Program (PDMP). HB249 was sent to the governor on April 7, 2017. The bill would shift administration of the PDMP from the Georgia Drugs and Narcotics Agency to the Georgia Department of Public Health and would impose several new requirements on prescribers. More >

MEDICAL DEVICES

Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New York Attorney General
By: Alan G. Minsk and Elizabeth Mulkey

The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the developers and companies associated with each app were required to amend promotional claims, modify privacy policies to protect consumers, and pay civil penalties. Though the United States Food and Drug Administration has previously provided guidance on mobile medical applications, developers should take note that state law can also be a basis for enforcement action. In these cases, to our knowledge, FDA has not acted. More > 

Do You Want a “.health” Web Domain Name? Do You Want to Prevent Others from Using Your Trademark in a “.health” Web Domain Name?
By: J. Tucker Barr and Sean T. Sullivan

“.health” (dot - health) is one of the newest domain extensions (also known as Top Level Domain, or TLD), reserved for brands, organizations, and people who provide health products, services, and/or information. The new domain extension is touted as a new tool for healthcare providers and health technology companies to further develop their brand online. Billed as “the premier web address for those who are advancing the health and wellness industry,” .health domain names will be available to the general public on December 5, 2017 (pursuant to the domain’s terms and policies). The .health domain extension may be viewed as an opportunity to add credibility to a domain in the healthcare space, but the registration process can also present challenges to trademark owners in protecting their intellectual property. Depending on the trademarks an organization holds or the role it plays in the healthcare industry, some healthcare entities may be able to reserve a .health domain name sooner than December 5, 2017, and should be mindful of these opportunities to protect their intellectual property and the risks of failing to act within this time period. More > 

NEWS FROM WASHINGTON

California Regents File State False Claims Act Case Against Healthcare Providers and Pharmacies for Allegedly Defrauding UC Student Health Insurance Plan
By: Sara M. Lord

The Regents of the University of California have filed a lawsuit against Studio Pharmacy, Excel Care Pharmacy, Pharma Pro Solutions, California Clinical Trials, and 17 individual defendants, including four physicians and two orthopedic surgeons, alleging violations of the California False Claims Act, common law fraud, negligent misrepresentation, and professional negligence against the defendants. The suit, which was filed in Superior Court on April 20, 2017, alleges that the defendants defrauded the University of California Student Health Insurance Plan (SHIP) of $12 million over a six month period and seeks restitution, damages, and costs. More >

HHS OCR Resumes HIPAA Enforcement Action Announcements: Four New Settlements and Penalties Totaling More than $5 million in a One Month Period
By: Kevin Coy

After a pause of nearly two months, the Department of Health and Human Services Office of Civil Rights has resumed its announcement of settlements for alleged HIPAA violations, with four new settlement agreements announced between April 12 and May 10, 2017. The settlements include penalties ranging from $31,000 to $2.5 million. 
More >

AGG Partner to receive Lifetime Achievement Award

The Daily Report has selected AGG attorney, William H. Kitchens, to receive a Lifetime Achievement award. Lifetime Achievement awards are given to lawyers who have had a lasting imprint on the legal community of Georgia. Mr. Kitchens will be recognized in special editorials sections in June as well as a Professional Excellence event on June 29, 2017. Please join us in congratulating Mr. Kitchens on this well-deserved honor. More > 

AGG Partners Recognized in Who’s Who Legal Guide 2017

Alan G. Minsk and Jennifer D. Burgar have been listed in the Who’s Who Legal Guide 2017 for the Life Science – Regulatory section. This recognition goes to attorneys who have distinguished themselves in their respective fields. More > 

AGG Grows Food and Drug Practice Team’s Washington, DC Presence with the Addition of Former FDA Senior Regulatory Counsel

AGG is pleased to welcome Deborah “Deb” Livornese to its Food and Drug Practice Team. Ms. Livornese joins AGG’s Washington, DC office from FDA’s Center for Drug Evaluation and Research’s Office of Regulatory Policy. Prior to FDA, Ms. Livornese practiced in a food and drug boutique law firm in Washington. With more than 25 years of legal experience, Ms. Livornese advises on pharmaceutical, medical device, cosmetic and food-related legal and regulatory issues. More >