On April 6, 2016, the Food and Drug Administration (FDA) published the final rule for the sanitary transportation of human and animal food. The rule aims to prevent food contamination during transportation by requiring covered entities involved in transporting human and animal food to follow recognized best practices for sanitary transportation. The rule seeks to prevent unsanitary practices such as the failure to properly refrigerate food, the inadequate cleaning of vehicles between loads, and the failure to properly protect food.
Paxil birth defect lawsuit cannot survive exclusion of evidence of later FDA warnings
Last week, the first of nine Paxil birth defect lawsuits in line for trial in Pennsylvania was dismissed after a judge excluded evidence of the drug’s later heightened FDA warning. Judge Kenneth Powell of the Philadelphia County Court of Common
DOJ launches pilot program for FCPA cases
On April 5, 2016, the DOJ announced a new Foreign Corrupt Practices Act (FCPA) enforcement pilot program with the goal of motivating companies to voluntarily self-disclose FCPA-related violations, to fully cooperate with the DOJ during investigations, and to promote greater
Joint Commission revises deemed status accreditation requirement for psychiatric hospitals
On March 25, 2016, the Joint Commission revised an accreditation requirement related to written patient care plans for psychiatric hospitals that use Joint Commission accreditation for deemed-status purposes. Psychiatric hospitals may achieve deemed status through Joint Commission surveys that meet
FTC Guidance for developers of mobile health apps
In the fall of 2015, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) released an online resource to assist mobile health application developers in determining whether they need to comply with the Health Insurance Portability and
Australian TGA on cyber security
In a timely note, the March 2016 edition of the Medical Devices Safety Update, put out by the Australian Therapeutic Goods Administration, highlights medical device cyber security as a key issue.
Interestingly, this comes shortly after the release by
Government panelists speak on Medicare overpayments final rule
At the DC Bar program “The Medicare Overpayments Final Rule: Government Perspectives and Compliance Considerations” (Mar. 29, 2016), a panel of speakers from the OIG, CMS, and private practice discussed perspectives on the final rule’s guidance about the return of