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

• Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight
• Form Drug Distribution Services Agreements May Not Be Formulaic
• Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling
• FDA Says Sharing Medical Product Information is Caring, to an Extent
• The Beat Goes On: FDA Continues to Maintain its Position on Off-Label Promotion Policy
• Changes to Sudanese Sanctions Program Could Benefit U.S. Life Sciences Companies (A Little)
• HHS Issues Final Revisions to the Common Rule – New Protections for Human Research Subjects
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Anyone Can Enter Into a Quality Agreement, It's the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight 
By: Alan G. Minsk 

A recent Warning Letter from the Food and Drug Administration illustrates the need to implement, execute, and follow-up on quality agreements—as opposed to just entering into them. Likewise, merely having a quality agreement does not excuse non-compliance. More >

Form Drug Distribution Services Agreements May Not Be Formulaic
By: Stephen D. Fox and Joel N. Gossner

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although these agreements often have a similar structure and contain many standard provisions, we reviewed a form agreement that omitted key provisions and contained burdensome obligations and terms that merited consideration. More > 

MEDICAL DEVICES

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling 
By: Alan G. Minsk and Elizabeth A. Mulkey

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information consistent with, but not actually provided in, the product labeling. The draft, “Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers,” which applies to drugs and medical devices, is one of a number of agency releases issued recently about product communications. FDA continues to evaluate how to handle product information dissemination, particularly after it has lost court cases relating to off-label promotion (about which we have written). While FDA’s recent guidances and other written communications are not legally binding, they offer insight into the agency’s current thinking. More > 

FDA Says Sharing Medical Product Information is Caring, to an Extent 
By: Alan G. Minsk and Kalie E. Richardson

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in the Federal Food, Drug, and Cosmetic Act (FDC Act). FDA has requested that any comments on this draft guidance be submitted within 60 days of the Federal Register notice, dated January 19, 2017, announcing the document’s availability. The Food and Drug Administration Modernization Act of 1997 and the recently enacted 21st Century Cures Act both reference how manufacturers may communicate healthcare economic information (HCEI) to payors and other related parties. This draft guidance aims to describe FDA’s current thinking on the permissible content of those communications. The draft guidance and this Bulletin are split into two parts: communications of HCEI about approved drugs and communications about investigational drug and medical device products. More > 

The Beat Goes On: FDA Continues to Maintain its Position on Off-Label Promotion Policy 
By: Alan G. Minsk and Genevieve M. Razick

The Food and Drug Administration recently reopened its docket for submission of written comments following its November 2016 public hearing, which addressed how to best align public health interests served by FDA’s regulatory approach related to company communications regarding unapproved uses, i.e., off-label promotion, of medical products with recent developments in science, technology, and the law. (We have discussed the public hearing in an AGG webinar.) In addition, the agency placed a Memorandum, “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” in the docket to provide additional background as it re-examines its off-label promotion policy. More >

NEWS FROM WASHINGTON

Changes to Sudanese Sanctions Program Could Benefit U.S. Life Sciences Companies (A Little)
By: Michael E. Burke

On January 13, 2017, President Obama signed the Executive Order “Recognizing Positive Actions by the Government of Sudan and Providing for the Revocation of Certain Sudan-Related Sanctions” that revoked many U.S. economic sanctions against Sudan. The Office of Foreign Assets Control (“OFAC”), on January 17, 2017, issued a new general license (at 31 C.F.R. §538.540) to the Sudanese Sanctions Regulations that enables U.S. persons and companies to (i) process transactions involving persons and entities in Sudan; (ii) import goods and services from Sudan; (iii) export goods, technology, and services to Sudan; and (iv) engage in transactions involving property in which the Government of Sudan has an interest. U.S. life sciences companies will be impacted by this change, but perhaps not in an anticipated manner. More > 

HHS Issues Final Revisions to the Common Rule – New Protections for Human Research Subjects
By: Kevin Coy and Maayan Y. Lattin

On January 19, 2017, the U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies issued a final rule to update “Federal Policy for the Protection of Human Subjects,” also known as “the Common Rule,” under 45 CFR 46, Subpart A. More >

AGG Partner Quoted in STAT Plus

AGG Partner Michael E. Burke was quoted in the January 11 STAT Plus article, “Will Trump’s Pick for the SEC ‘Dial Back’ Pharma Fines for Overseas Bribes?” STAT is a health and science news site produced by Boston Globe Media. Subscription required. More >

Four Members of the Healthcare Group Elected Partner

The AGG Healthcare Practice Group is proud to announce that four of its team members were recently elected to partnership in the firm. Congratulations to Lanchi N. Bombalier, Jennifer D. Burgar, Jessica T. Grozine, and W. Jerad Rissler!

AGG Partners Alan Minsk and Michael Burke will present “Building Quality (Agreement) Into Your Product” at the offices of Arnall Golden Gregory LLP on February 21, 2017 in Atlanta, GA.

AGG Attorneys Alan Minsk Elizabeth Mulkey will present a complimentary webinar "FDA issues New Pronouncements about Product Information Dissemination” on February 23, 2017.

AGG Partner Alan Minsk will present “Utilization of Medical Literature Reviews for Safety Surveillance” and co-present “Thinking Outside the Box in Gathering Postmarket Date” at the 3rd Annual Global Postmarket Surveillance of Medical Devices Conference on February 24, 2017 in Alexandria, VA.

AGG Partner Alan Minsk will present “Drugs and Biologics: Labeling” at the American Conference Institute’s 29th FDA Boot Camp on March 23, 2017 in New York, NY.