Drugs

Senate Approves FDA ‘Active Moiety’ Definition

Attorney Andrew Goldfarb (Zuckerman Spaeder) says the Senate approved 3/11 S. 415, a bill that would amend the Federal Food, Drug, and Cosmetic Act to replace the phrase “active ingredient (including any ester or salt of the active ingredient)” with FDA’s regulatory definition of “active moiety.” Goldfarb writes in an online post that the bill is intended to reduce drug costs by ensuring that exclusivity is awarded only for innovation that represents a true therapeutic advance for patients. “The unanimous passage by the Senate suggests the bill has a strong chance to become law,” he writes.

The bill would clarify a long-running, hotly-litigated Waxman-Hatch question about when a new drug qualifies for exclusive marketing rights intended to reward innovation, Goldfarb says. FDA has said that Congress did not intend to award new active ingredient exclusivity for a very slight change to the chemical structure of an active ingredient that has no therapeutic significance and thus issued regulations saying that five-year exclusivity is available only when a drug contains a new chemical entity, defined as a drug that contains no active moiety that has been approved by FDA in another application.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome