Gregory M. Luce

New FDA Guidance Largely Affirms Prior Policy on Off-Label Responses but Distinguishes Between Public and Nonpublic Requests
John T. Bentivoglio,Jennifer L. Bragg,Michael K. Loucks,Gregory M. Luce, December 30, 2011
On December 27, 2011, the U.S. Food and Drug Administration (FDA) released a draft guidance (Draft Guidance) on how pharmaceutical and medical device manufacturers should respond to unsolicited requests for information about unapproved (or uncleared) indications or conditions of use related to...

Sunshine Act Begins to See Light of Day: CMS Issues Proposed Rule Implementing Physician-Payment Reporting Requirements
John T. Bentivoglio,Jennifer L. Bragg,Alexander R. Cohen,Maya P. Florence,Michael K. Loucks,Gregory M. Luce, December 21, 2011
On December 14, 2011, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited proposed rule to implement Section 6002 of the Affordable Care Act (ACA), commonly known as the Physician Payment Sunshine Act (Sunshine Act). While Section 6002 required the Secretary of Health and...

False Claims Act Investigations of Health Care Companies: Time for a New Approach?
John T. Bentivoglio,Jennifer L. Bragg,Michael K. Loucks,Gregory M. Luce, June 22, 2011
Pharmaceutical, medical device and health care companies face an onslaught of False Claims Act cases alleging a variety of fraudulent and unlawful practices. Traditionally, companies have responded by cooperating with government subpoenas and, eventually, negotiating resolutions that remove the...