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

• Recent Developments on the Opioid Front 
• How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II 
• Early Victory: Judge Dismisses Qui Tam Suit Against UnitedHealthcare 
• California Enacts Limitations on Copayment Coupons
• Price-Fixing Allegations Against Generic Drug Manufacturers Broaden as State Attorneys General Seek Amended Complaint
• FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices 
• FDA Issues Guidance on Drug and Device Classifications 
• Upcoming Events

PHARMACEUTICALS

Recent Developments on the Opioid Front
By: Sara M. Lord and Deborah L. Livornese

The “Opioid Crisis” continues to drive measures that will significantly affect the pharmaceutical industry in general, the relationship between prescribers and their patients, and the role of regulators – and law enforcement – in medical decisions. As the White House is reportedly preparing to declare the opioid epidemic a national emergency, which could lead to a wide range of agency actions, and as the number of government-backed lawsuits against the pharmaceutical companies continues to grow, with reports almost daily of new cases filed across the country, federal and state legislators, too, are taking up the cause. More >

How to Pay the Piper: FDA Issues New Guidances for PDUFA VI and GDUFA II By: Deborah L. Livornese and Genevieve M. Razick

FDA recently issued two draft guidances: Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (GDUFA II), which clarify FDA’s interpretation of some of the major changes to both user fee programs. PDUFA was reauthorized for the fifth time and GDUFA for the second time by the Food and Drug Administration Reauthorization Act (FDARA), which we outlined in an earlier bulletin. The PDUFA VI and GDUFA II user fee changes took effect on October 1, 2017, which was the beginning of the 2018 fiscal year, and will run through fiscal year 2022, when the programs will again need to be reauthorized. This bulletin does not cover the entirety of both guidances, but highlights some areas in which the guidances have provided needed clarification to certain FDARA provisions. More >

Early Victory: Judge Dismisses Qui Tam Suit Against UnitedHealthcare
By: Sara M. Lord and Kara Gordon Silverman

On October 5, 2017, in United States of America ex rel. Swoben v. Scan Health Plan, et al. (“Swoben”), Judge John F. Walter of the United States District Court for the Central District of California granted United Health Group, Inc.’s (“UnitedHealth”) Motion to Dismiss the government’s False Claims Act (“FCA”) Complaint alleging that UnitedHealth fraudulently inflated patient risk scores to obtain higher reimbursements from Medicare Advantage (“MA”). The court dismissed the Complaint with leave to amend by October 13, 2017. But, on October 12, 2017, in a surprise turn of events, the government instead filed a Notice of Dismissal Without Prejudice. More >

California Enacts Limitations on Copayment Coupons
By: Jennifer Downs Burgar and Elizabeth A. Mulkey

As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a law to limit the use of copayment discounts, commonly offered by pharmaceutical manufacturers as copay cards or coupons. California is not the first state pass legislation limiting copay cards; Massachusetts banned copay cards until 2012, when the state loosened restrictions in response to pressure from consumers and the pharmaceutical industry. More >

Price-Fixing Allegations Against Generic Drug Manufacturers Broaden as State Attorneys General Seek Amended Complaint
By: Jeffrey S. Jacobovitz and Samuel M. Shapiro

On October 31, 2017, the Attorneys General of forty-five states and the District of Columbia (the “State AGs”) moved to amend a December 2016 complaint alleging a broad price-fixing scheme among key players in the generic drug industry. The motion to amend, filed in United States District Court for the Eastern District of Pennsylvania, seeks to add numerous generic drug companies to the list of defendants named in an earlier complaint. The motion further seeks the court’s permission to add a number of medications to the list of drugs for which prices were allegedly fixed. More >

DEVICES

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices
By: Alan G. Minsk, Deborah L. Livornese and Genevieve M. Razick

On October 25, 2017, the Food and Drug Administration issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would require the submission of a new premarket notification (commonly referred to as a 510(k)). The guidance document updates and supersedes FDA’s original guidance on the topic, dated January 10, 1997. The final guidance provides additional information on how to use a risk assessment to evaluate whether a change requires a new 510(k), gives specific examples of when a change might require a new 510(k), clarifies important terms, and makes recommendations on how to document decisions on whether to submit a 510(k). More >

FDA Issues Guidance on Drug and Device Classifications
By: Deborah L. Livornese and Genevieve M. Razick

On September 26, 2017, the Food and Drug Administration (FDA) announced the availability of a final guidance entitled Classification of Products as Drugs and Devices & Additional Product Classification Issues to clarify FDA’s thinking on classifying products as drugs, devices, biological products, or combination products. In the guidance, FDA sets forth some general concepts about its approach to the classification question and also provides illustrative examples of classification determinations with some limited explanation. The guidance also describes the process for requesting a formal classification determination (RFD) from FDA. This guidance finalizes and combines two draft guidance documents on the subject – “Classification of Products as Drugs and Devices & Additional Product Classification Issues” and “Interpretation of the Term ‘Chemical Action’ in the Definition of Device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.” More >

AGG Partner Kevin Coy will present the complimentary webinar "Tick Tock: The Clock is Ticking But There is Still Time to Comply with the EU General Data Protection Regulation" on December 5, 2017.

AGG Partners Alan G. Minsk and Michael E. Burke will present the complimentary webinar "Building Quality (Agreement) into Your Product" on December 14, 2017.