Drugs

FTC Supports FDA Deterring Petition Abuse

The Federal Trade Commission (FTC) has approved 5-0 a statement commenting on an FDA draft guidance that aims to deter drug companies from abusing the citizen petition process to delay approval of and competition from generic drugs. The comment says that while some citizen petitions raise genuine issues for scientific consideration, many do not and are denied by FDA as lacking merit.

Answering a petition requires significant FDA resources and time, FTC says, including careful consideration of the issues by appropriate FDA staff, and preparation, review, and vetting of the agency response.

FDA says it has investigated complaints of citizen petition abuse as potential violations of federal antitrust law, and in 2017 filed a federal court complaint charging that Shire ViroPharma illegally maintained its monopoly power by abusing government processes, including the citizen petition process.

FTC says it shares FDA concerns about patient access to lower-cost generic drugs and supports FDA efforts to deter abuse of the citizen petition process. FTC also says it stands ready to work closely with FDA on citizen petition abuse and other issues that may harm competition and lead to higher prescription drug costs.

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