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

• The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information 
• You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter 
• The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and Congressional Entities Raises the Stakes for the Pharmaceutical Industry in General and for Opioid Manufacturers in Particular
• Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs
• Dow Takes its Gene Patents Row with Bayer to the Supreme Court to Avoid the $455 Million Arbitral Award 
• FDA Issues Guidance on Use of Real-World Evidence for Medical Devices 
• Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are the Focus 
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information
By: Alan G. Minsk and Elizabeth A. Mulkey

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing what it considered to be a false and misleading professional detail ad. The promotion for a prescription pain medication, an opioid agonist, omitted risk association and failed to include the full FDA-approved indication. The devil was in the details and, well, those details were absent. More >

You Can’t Pass the Regulatory Compliance Buck with a Quality Agreement; FDA Reiterates the Point in a Recent Warning Letter
By: Alan G. Minsk

Companies can’t sign quality agreements and then say “we’re done.” This message was brought home with a recent Warning Letter issued by the Food and Drug Administration to a pharmaceutical company for violating current good manufacturing practice requirements for combination products, drugs, and medical devices. The Warning Letter included a myriad of quality-related concerns, including inadequate investigations, poorly written procedures for complaint handling, and failure to establish and maintain procedures for device design verification and validation. The agency requested that the company schedule a regulatory meeting; being beckoned to the principal’s office is not a good sign. More >

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and Congressional Entities Raises the Stakes for the Pharmaceutical Industry in General and for Opioid Manufacturers in Particular
By: Sara M. Lord and Deborah L. Livornese 

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization. The report, which is part of a wide-ranging congressional investigation of opioid sales and marketing efforts by major opioid manufacturers, focuses on Insys’s alleged efforts to increase sales of Subsys®, its fentanyl drug, which is approved by the Food and Drug Admininstration (FDA) for the management of breakthrough pain in adult cancer patients, by fraudulently abusing the prior authorization process. Other civil and criminal investigations of Insys’ sales and marketing of Subsys by a range of federal, state, and local authorities have included allegations that Insys also engaged in various schemes to bribe practitioners to prescribe Subsys for non-FDA-approved uses. For pharmaceutical companies, as well as prescribers, the expanding governmental focus on opioids in general, and the multi-faceted, multi-party investigations of Insys in particular, constitute a clear warning to review their sales practices, strengthen their internal oversight, and upgrade their compliance policies regularly. More >

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs
By: Deborah L. Livornese and Kalie E. Richardson

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and other fees, and FDA’s review performance goals. More >

Dow Takes its Gene Patents Row with Bayer to the Supreme Court to Avoid the $455 Million Arbitral Award
By: Gene M. Burd

When a company agrees to arbitrate an international patent licensing agreement, the avenues for the appeal of the resulting arbitral award are very limited. Even the invalidity or expiration of the underlying patents may be insufficient to overturn the decision of the panel. Dow Agrosciences LLC (“Dow”) experienced that first hand in its fight against Bayer CropScience AG’s (“Bayer”) patent infringement claim after the Federal Circuit affirmed judgment of a district court to recognize the $455 million arbitral award issued by the International Court of Arbitration. More >

MEDICAL DEVICES

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices
By: Deborah L. Livornese and Elizabeth A. Mulkey

On August 31, 2017, the Food and Drug Administration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July 2016 draft guidance on this topic, FDA discusses the potential uses of real world data and the factors it evaluates to determine whether that data can support a regulatory decision. Additionally, FDA addresses when an Investigational Device Exemption (IDE) may be needed to collect and use real-world data for determining the safety and effectiveness of a device. More >

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are the Focus
By: Deborah L. Livornese and Genevieve M. Razick

Over the past several months, the Food and Drug Administration has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device to be used in clinical studies to collect safety and effectiveness data to be included in premarket approval (PMA) or premarket notification (510(k)) submissions to the FDA. More >

AGG Partner Michael E. Burke will present a webinar "Drafting Foreign Corrupt Practices Act Compliance Provisions in Cross-Border Distribution Agreements," on September 20, 2017.

AGG Attorneys Alan G. Minsk and Elizabeth A. Mulkey will present "Fraud and Abuse of Co-Pay Cards, Coupons and Vouchers" at the PMDA 27th Annual Sharing Conference, on October 23, 2017, in Baltimore, MD.