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

• We Agreed to What? Lessons From a Recent Federal Court Decision on Arbitrability 
• FDA Files Complaints in Federal Court Against Two Stem Cell Clinics
• Eleventh Circuit Sets Up Circuit Split on False Claims Act Statute of Limitations Issues
• Say My Name, Say My Name: FDA Posts List of RLD Access Inquiries 
• When It Rains, It Pours in the Land of Sunscreens
• Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

 Industry Insights

PHARMACEUTICALS

We Agreed to What? Lessons From a Recent Federal Court Decision on Arbitrability
By: Gene M. Burd and Bradford J. Kelley 

Cutting corners in a rush to conclude a lucrative business deal may lead to a contract that misses important legal terms and conditions, such as an arbitration clause, that the company actually intended to include in the agreement. Following appropriate contracting procedures is especially important for non-U.S. companies that expect resolution of their disputes by a neutral arbitration but, instead, could be hauled into a U.S. court with unfamiliar procedures under foreign law. A recent Oregon federal court decision denying a Dutch company’s request to arbitrate its dispute with an Oregon customer aptly demonstrates this point. More > 

FDA Files Complaints in Federal Court Against Two Stem Cell Clinics 
By: Deobrah Livornese and Genevieve Razick

FDA historically has limited its enforcement actions against stem cell clinics to warning letters. On May 9, 2018, FDA went a step further and filed two complaints in federal court seeking permanent injunctions that would prevent two stem cell clinics from marketing stem cell products prior to receiving FDA approval. This action signifies FDA’s willingness to take legal action against stem cell clinics that do not heed FDA’s warning. As noted on its website, “FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products. More >

Eleventh Circuit Sets Up Circuit Split on False Claims Act Statute of Limitations Issues 
By: Aaron M. Danzig and Samuel M. Shapiro

Civil lawsuits brought under the federal False Claims Act (FCA) must be filed either within six years of the date on which the violation is committed, or three years after the date when material facts are known or should have been known by a government official with responsibility to act. In United States ex rel. Hunt v. Cochise Consultancy, Inc., the Eleventh Circuit Court of Appeals held that the three-year limitations provision could apply to a qui tam relator’s complaint even where the government declines to intervene in the case. Secondly, the Court determined that the three-year period begins to run when the government, rather than the relator, obtains knowledge of the alleged misconduct. Both holdings represent a split from decisions rendered by other federal circuit courts, meaning the Supreme Court may ultimately have to weigh in. More >

Say My Name, Say My Name: FDA Posts List of RLD Access Inquiries
By: Deborah L. Livornese and Elizabeth A. Mulkey 

On May 17, 2018, the Food and Drug Administration posted a list of pharmaceutical manufacturers that FDA alleges have blocked potential generic drug applicants from accessing drug samples needed to obtain approval for their products. The list is part of FDA’s Drug Competition Action Plan, announced last year, which aims to facilitate “increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.” Like the 1999 Destiny’s Child hit, the agency is highlighting what it calls “gaming” of the regulatory system, and rather than merely alluding to companies “actin’ kinda shady,” FDA is naming names.  More > 

When It Rains, It Pours in the Land of Sunscreens 
By: Deborah L. Livornese

As Memorial Day approaches, FDA has shed light on several important facets of sunscreen regulation this week, issuing two draft guidances and a Warning Letter. One guidance is sunscreen specific: Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application (the “Draft Enforcement Policy”). The second is relevant for topical OTC drugs to be marketed under a monograph: Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations (the “MUST Draft Guidance”). More >

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors
By: Jeffrey S. Jacobovitz and Bradford J. Kelley

The Federal Trade Commission (FTC) has brought a series of cases recently involving drug manufacturers’ alleged efforts to delay competition from generic drug companies. The FTC’s case against Shire ViroPharma Inc. is another recent example of the agency’s actions in this field. More >