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: Not Responding to an FDA 483 in a Timely Manner
• Office of Inspector General Urges CMS to Address Payment Issues Associated with DME-Covered Infusion Drugs
• Alive and Kicking: FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective
• Change, Change, Change: FDA Issues Draft Guidance on When Changes to an Existing Medical Device Require a New 510(k)
• Government Charges Sixteen In $175 Million Pharmacy Fraud
• Burma Sanctions Regulations to be Terminated
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Things That Make You Go Hmmm – Part II: Not Responding to an FDA 483 in a Timely Manner
By: Alan G. Minsk

Approximately ten years ago, I wrote an article entitled, “Things That Make You Go Hmmm,” inspired by a photograph of my then-three-year old son with his hand on his cheek in a contemplative pose. That article was about common mistakes some life science companies make when handling Food and Drug Administration (FDA) inspections – mistakes which left me scratching my head in amazement. Ten years later, I still scratch my head when I read about companies failing to respond to FDA inspectional deficiencies in a timely manner. More > 

Office of Inspector General Urges CMS to Address Payment Issues Associated with DME-Covered Infusion Drugs
By: Alan K. Parver

On September 7, 2016, the Office of Inspector General (OIG) released a report entitled “CMS Should Address Medicare’s Flawed Payment System for DME Infusion Drugs” (OEI-12-16-00340). This report is a follow-up to an April 2015 report entitled “Recommendation Followup Memorandum Report: Implementing OIG Recommendation Could Have Reduced Payments for DME Infusion Drugs by Hundreds of Millions of Dollars,” which itself was based on a 2013 OIG report on the same issue. More >

Alive and Kicking: FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective
By: Alan G. Minsk and Kelley C. Nduom

The Food and Drug Administration’s Office of Prescription Drug Promotion didn’t take the summer off, despite the uncertainty surrounding any new enforcement action relating to off-label promotion. Specifically, OPDP recently issued two Notice of Violation letters to drug companies for promoting investigational new drugs as safe and effective. More > 

MEDICAL DEVICES

Change, Change, Change: FDA Issues Draft Guidance on When Changes to an Existing Medical Device Require a New 510(k)
By: Alan G. Minsk

Recently, the Food and Drug Administration issued a draft guidance to help the medical device industry evaluate when a change to an existing medical device might require a new 510(k) submission. While the draft guidance is not legally binding, and FDA will accept comments, it represents the agency’s current thinking. More >

NEWS FROM WASHINGTON

Government Charges Sixteen In $175 Million Pharmacy Fraud
By: Sara M. Lord

On September 1, 2016, the United States Attorney’s Office for the Southern District of Florida filed a five-count information, variously charging sixteen individuals, including three physicians, in connection with a scheme to defraud government and private insurers of $175 million. United States v. Carroll et al., #0:16-cr-60227 (S.D. Fla.). The information alleges an extremely complex scheme, which the defendants operated through pharmacies functioning as “fronts,” call centers, and a network of allegedly “corrupt physicians.” More > 

Burma Sanctions Regulations to be Terminated
By: Michael E. Burke

On September 14, 2016, the President announced his intention to terminate the national emergency with respect to Burma, the effect of which will be to end the current U.S. sanctions program against that country as overseen by the Department of the Treasury’s Office of Foreign Assets Control (OFAC). This decision will be legally effective when the President issues a new Executive Order terminating that national emergency and revoking the Burma Executive Orders. At that time, the sanctions imposed under OFAC’s Burmese Sanctions Regulations will no longer be in effect, and OFAC will formally remove the Burmese Sanctions Regulations from the Code of Federal Regulations and take other administrative actions as necessary. More >

AGG Partner William Kitchens Authors Chapter in Technological Innovation: Generating Economic Results

AGG Partner William H. Kitchens wrote the chapter, “FDA Regulatory Approval Process for Medical Products,” in the recently published book, Technological Innovation: Generating Economic Results (2d edition, 2016). The book is volume 26 of the series entitled Advances in the Study of Entrepreneurship, Innovation & Economic Growth (Emerald Group Publishing).

Arnall Golden Gregory Wins Litigation Healthcare Department of the Year Award

The Fulton County Daily Report, which covers the latest in Georgia law, trial developments and law firms, recently announced its annual winners for law firms in five categories of litigation, and AGG is proud to have been selected as this year’s winner for its work in healthcare litigation. More >

AGG Partner Alan Minsk will present a complimentary webinar “Change, Change, Change: FDA Issues Draft Guidance on When Changes to an Existing Medical Device Require a New 510(k)” on September 29, 2016. 

AGG hosts its annual, complimentary Employment Law Seminar “Working Overtime to Manage Your Workforce,” offering the coaching you need to tackle today’s employment challenges, on October 7, 2016, in Atlanta, GA. 

AGG Partner Alan Minsk will be speaking on medical device advancement from a regulatory science perspective at the UGA Medical Device Regulations Conference on November 1, 2016, in Athens, GA.