Staff Changes at the FDA’s Office of Regulatory Affairs: New Regulators and Shuffling Around the Lawyers

On September 3, 2013, FDA Commissioner Margaret Hamburg, M.D. announced in an email to FDA staffers that Melinda Plaisier would become the agency's new permanent Associate Commissioner for Regulatory Affairs (ACRA). Plaisier had been the acting commissioner since last October. In recent months there have been significant changes in the Headquarters of the Food and Drug Administration's Office of Regulatory Affairs (ORA). We have previously covered the ORA, discussing its Office of Criminal Investigations (OCI). The OCI has played a large role in several high-profile settlements involving off-label marketing or deceptive promotional practices and is currently headed by former Department of Justice veteran, John Roth. However, unlike Roth, other notable lawyers working in leadership roles at both the ORA's Headquarters and the Office of Global Regulatory Operations and Policy (which oversees the ORA) have recently left for other parts of the agency and the private sector. It is unclear whether this represents a shift in enforcement policy priorities at the agency or is merely a temporary trend. Replacing the Associate Commissioner for Regulatory Affairs With several thousand employees, the ORA has responsibility for imports, inspections and investigations, compliance and enforcement, and field laboratory operations. In October 2012, the Office was reorganized, naming Melinda Plaisier the Acting Associate Commissioner for Regulatory Affairs. As reported by Regulatory ...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs