Life Sciences Partner Testifies at FDA Off-Label Communications Public Hearing
Life sciences partner Kellie Combs (Washington, D.C.) testified Nov. 9 at a public hearing on behalf of the Medical Information Working Group (MIWG) urging the U.S. Food and Drug Administration (FDA) to move quickly to establish clearer regulatory policies regarding drug manufacturers’ communication of scientific and medical information not contained in FDA-approved labeling.
Ms. Combs said the FDA’s current framework, which restricts the extent to which manufacturers can share truthful and non-misleading information that is not contained in the FDA-approved labeling, needs to be modified in the interest of public health. “Manufacturers often are in possession of the best and most current information available about their products, and in some instances, may be the only source of such information. To facilitate informed health care decision-making and to enhance patient care, FDA must ensure that there are clearly defined and effective pathways for manufacturers to communicate off-label information about their products,” she explained.
She also emphasized that FDA’s current framework is inconsistent with constitutional requirements. Ms. Combs testified, “In failing to address or even mention First and Fifth Amendment dictates, [FDA’s] hearing notice itself suggests that the agency does not appreciate, or may be unwilling to accept, the limitations imposed by the Constitution.”
MIWG is an informal working group of biopharmaceutical product and medical device manufacturers. Members of MIWG are: Allergan PLC, Amgen, Inc., Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim Pharms., Inc., Bristol-Myers Squibb Company, Eli Lilly and Company, Genentech, Inc., GlaxoSmithKline LLC, Johnson & Johnson, Novartis Pharmaceuticals Corp., Novo Nordisk, Inc., Pfizer Inc, and Sanofi US.
Other Ropes & Gray attorneys representing MIWG are government enforcement partner Joan McPhee (New York), appellate and Supreme Court partner Doug Hallward-Driemeier (Washington, D.C.), life sciences senior counsel Alan Bennett (Washington, D.C.), and business & securities litigation associates Emerson Siegle and Jonathan Ference-Burke (both of Washington, D.C.).