Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Health Care Blog, in “FDA Clarifies Rule on Tobacco Products in Medical Realm,” by Bronwyn Mixter.
Following is an excerpt:
This clarifies that manufacturers aren’t promoting off-label uses of their products if they just know how doctors are using their products, Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told me. While doctors can prescribe medical products for unapproved uses, manufacturers are prohibited from promoting such uses.
The rule’s statement on off-label promotion is a “big clarification,” he said. Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory and clinical trial issues.
