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
Industry Insights
PHARMACEUTICALS
Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?
By: Alan G. Minsk
In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief Executive Officer, the government’s attempt to take enforcement action against dissemination of off-label information was blocked as violating the First Amendment, taking a page from Triumph’s 1981 classic rock song, “Fight the Good Fight.” More >
MEDICAL DEVICES
Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company
By: Sara M. Lord
On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A subsidiary of the company, Olympus Latin America, Inc. (OLA), will pay another $22.8 million to resolve criminal charges relating to the Foreign Corrupt Practices Act (FCPA) in Latin America. The settlement, which has been billed as the largest total amount paid in U.S. history for violations involving the AKS by a medical device company, includes several components. More >
Telehealth and Medicare: MedPAC Presents Updated Research to the Commission
By: Andrew B. Flake and Barbara J. Rogers
The status of expanded federal telehealth reimbursement remains uncertain. Continuing an ongoing national policy conversation, the Medicare Payment Advisory Commission (MedPAC) held its second meeting on March 3, 2016, under the title “Telehealth Services and the Medicare Program.” MedPAC previously met in November 2015 to discuss this topic after the commission expressed interest in learning more about “the extent to which telehealth is used within the Medicare program and outside the program.” Although the March meeting updated previously presented research, MedPAC again concluded that “evidence of efficacy of telehealth services is mixed.” More >
NEWS FROM WASHINGTON
New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products
By: Kevin Coy
On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was found to be inadequate by the European Court of Justice (“ECJ”) in October. The Commission also released a draft opinion which, if adopted, would find the new Privacy Shield to be an adequate means of transferring personal data from the EU to companies in the US that elect to participate in the new program. The Privacy Shield will not become effective until the final approval of the Commission’s adequacy determination, which is not expected for several months. More >
Big Data Analytics Under HIPAA
By: Kevin Coy and Neil W. Hoffman, Ph.D.
Such privacy laws and regulations as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule can have a significant impact on the development of health care data analytics in cases where those analytics rely upon, or are developed using, HIPAA-regulated protected health information. Data analytics, also referred to as “big data” when done on a large scale, are often viewed as having the potential of transforming health care, enabling providers to use population data in identifying and preventing diseases, developing treatments, and reducing costs of health care. As recently noted by the Privacy and Security Workgroup (PSWG), benefits of data analytics could include “safer treatments, the ability to target communities and individuals with tailored interventions, and the ability to respond to the spread of diseases more rapidly.” More >
