Drugs

NCLA Warns of FDA ‘Genetic Variants’ Overreach

The New Civil Liberties Alliance (NCLA) says it is concerned that an FDA decision that will prevent the dissemination of information related to the genetic variants on drug response (pharmacogenomics or PGx) will adversely affect public health. The NCLA concern is expressed in its 4/14 comment supporting a 1/9 citizen petition submitted by the Coalition to Preserve Access to Pharmacogenomics Information.

NCLA says it is concerned that (1) FDA efforts to suppress truthful speech violate the First Amendment rights of clinical laboratories as well as those of doctors and patients who want to receive PGx information from those labs, and (2) the FDA defense of speech suppression cannot be reconciled with the U.S. Constitution’s separation of powers.

“FDA claims unlimited administrative discretion to prohibit the operation of all clinical laboratories,” NCLA says, “but it does not have the power to prosecute only those laboratories that disseminate truthful information of which FDA disapproves.”

The alliance also says the FDA position raises significant due process concerns because it deprives the regulated community of fair notice of how to conform its conduct to the agency’s expectations and permits enforcement officials to make up the rules on the fly.

NCLA calls on FDA to rescind its speech-suppression policy for laboratories that engage in PGx testing and says that any new policy on PGx tests should be developed through a notice-and-comment rulemaking proceeding that complies with the Administrative Procedures Act.

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

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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