On January 13, the Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 14-01, in which the OIG stated it would not impose sanctions against an independent placement agency referring seniors to two senior communities
FDA overhauls guidance on “Dear Doctor” letters for drug risks
On January 22, the US Food and Drug Administration (“FDA”) finalized its guidance on the content and format that drug manufacturers should use to warn physicians of newly-discovered risks. These letters are referred to as “Dear Health Care Provider letters”
Study released regarding the “Keep Your Health Plan Fix”
After receiving criticism that many Americans would not be able to keep their existing health insurance plans due to the heightened minimum coverage requirements of the Affordable Care Act (“ACA”), President Obama announced a policy on November 14, 2013 that
White House touts success of electronic health records incentive program, but cited survey also indicates limits to continued progress
The National Coordinator for Health Information Technology at the US Department of Health and Human Services (“HHS”), Karen DeSavlo, recently published a blog post touting the success of the electronic health records (“EHR”) incentive program. Stating that the widespread adoption
Food safety issues to watch in Canada in 2014
Two reports released at the end of 2013 have raised concerns over Canada’s food safety system and will require action by the Canadian Food Inspection Agency (“CFIA“) in 2014.
In December 2013, the United States Food Safety and
FDA Warning Letter update
The FDA issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement. A Warning Letter is the FDA’s principal means of
FDA issues proposed rule to protect food against intentional adulteration
On December 24, 2013, the FDA issued a proposed rule entitled “Focused Mitigation Strategies to Protect Food against Intentional Adulteration.” Passed under the Food Safety Modernization Act (“FSMA”) in 2011, the FDA issued this rule to focus on food defense,
Maine becomes second state to require GMO labeling
In early January, Maine became the second state in the country to implement a law that requires labeling for foods produced with genetically modified organisms (GMOs). However, the requirement will go into effect only after four other contiguous states (at
Department of Health and Human Services releases 2014 regulatory agenda
The Department of Health and Human Services (“HHS”) released its Semiannual Regulatory Agenda on January 7, 2014, as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. The FDA is the HHS agency charged with promulgating regulations
FDA stays out of natural fight
Earlier this month, the US Food and Drug Administration (“FDA”) sent a letter to three federal judges refusing to determine whether foods with genetically modified ingredients can be labeled as “natural.” The letter was in response to three federal court