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

• Brexit and Life Sciences Companies
• Arizona Enacts Law Permitting Off-Label Promotion
• Right-to-Try or Right to Ask?
• I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion
• United Medical Instruments Inc. Settles Potential Civil Liability for Alleged Violations of the Iranian Transactions and Sanctions Regulations
• New HHS OCR Director Appointed – A Change in Course for HIPAA Enforcement?
• Antitrust Exemption for Health Insurance Companies May Come to a Close
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Brexit and Life Sciences Companies
By: Michael E. Burke

The United Kingdom (UK) government served notice on March 29, 2017, under Article 50 of the Treaty on European Union that it intends to withdraw from the European Union (EU). There is no guide to managing a departure under Article 50 since no EU member has ever left the pact. The EU and UK have up to two (2) years to negotiate the terms of the UK’s departure but certain EU members, including Germany, are pressing for the process to be completed on a faster timeline. U.S. life sciences companies should not panic about what Brexit means for their business, but should plan ahead. More > 

Arizona Enacts Law Permitting Off-Label Promotion 
By: Alan G. Minsk and Elizabeth A. Mulkey

As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not approved by FDA. However, on March 21, Arizona Governor Doug Ducey signed a bill into law that challenges FDA’s prohibitive stance on off-label promotion.  More >

Right-to-Try or Right to Ask? 
By: Alan G. Minsk and Kalie E. Richardson

Recently, the American Society of Clinical Oncology (ASCO), a prominent medical organization, announced that it does not support so called “right-to-try” laws. Right-to-try legislation, which has now gained support in 33 states, focuses on getting terminally ill patients access to experimental products still in Phase 1 testing. The movement, led by the Goldwater Institute, attempts to remove FDA from the process completely and allow doctors and patients to negotiate directly with manufacturers for expanded access to experimental products. AGG has previously written about state right-to-try legislation. More >

MEDICAL DEVICES

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion 
By: Alan G. Minsk

Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not dead.” So, could be the Food and Drug Administration’s recent cry after it issued this month a Warning Letter to a Canadian medical device company selling its product in the United States. More >

United Medical Instruments Inc. Settles Potential Civil Liability for Alleged Violations of the Iranian Transactions and Sanctions Regulations
By: Michael E. Burke 

On February 28, 2017, United Medical Instruments, Inc. (UMI), a California corporation, settled its potential civil liability with the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) in the amount of $515,400 for 56 alleged violations of the Iranian Transactions and Sanctions Regulations (ITSR). UMI’s settlement will be effective with: (i) its compliance with the terms of its September 24, 2013 Settlement Agreement with the U.S. Department of the Commerce’s Bureau of Industry and Security; and (ii) its payment of $15,400 to the U.S. Department of the Treasury. More > 

NEWS FROM WASHINGTON

New HHS OCR Director Appointed – A Change in Course for HIPAA Enforcement?
By: Kevin Coy

In late March, Roger Severino was appointed to be the new Director of the Department of Health and Human Services Office of Civil Rights (HHS OCR), the office responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules as well as civil rights laws pertaining to HHS. Mr. Severino replaces Jocelyn Samuels who led HHS OCR from 2014 until her departure from the office earlier this year. More >

Antitrust Exemption for Health Insurance Companies May Come to a Close
By: Jeffrey S. Jacobovitz and Kalie E. Richardson 

Recently, the House of Representatives voted to pass H.R. 372, also known as the Competitive Health Insurance Reform Act of 2017, which would close the longstanding antitrust immunity granted to health insurance companies. The bill would amend the McCarran-Ferguson Act of 1945, which exempted the “business of insurance” from federal regulations, including some federal antitrust laws. Under McCarran-Ferguson, the business on insurance was left to be regulated by the states as they saw fit. This meant that insurers are still subject to any state antitrust laws, as well as the federal antitrust laws covering certain Sherman Act violations. More >

AGG Attorneys Recognized as JD Supra Top Authors

Alan G. Minsk and Barbara J. Rogers have been selected as “JD Supra Top Authors” for the level of visibility and engagement they attained with readers. Mr. Minsk was recognized in both the Pharmaceutical and Medical Device industries (and was ranked No. 1 in the Medical Device category). Ms. Rogers was recognized in the Healthcare industry, with a No. 4 ranking. Only 10 lawyers nationwide (out of the thousands of authors JD Supra published during 2016) are recognized in each category.

Bill Kitchens Spoke on the FDA and Its Impact on Tort Litigation

AGG senior counsel William H. Kitchens presented “The FDA and Its Impact on Tort Litigation: Oversight of Health Protection and Off-Label Promotion,” at the Institute for Continuing Legal Education Seminar Toxic & Mass Torts on March 30, 2017 in Atlanta. 

AGG senior counsel William H. Kitchens will present at the Southeastern Medical Device Association's annual conference on April 27, 2017 in Atlanta on a panel exploring the topic "Innovative Practices in Regulatory Strategies."

AGG partner Alan Minsk will present "The Latest on FDA and Off-Label Promotion at the Orthopedic Surgical Manufacturers Association Spring Meeting on April 27, 2017.(Member access only)