Drugs

Combination Product Designation Appeal Deadlines Sought

Epstein Becker Green is asking FDA to establish a reasonable review timeline for assessing appeals of letter of designation decisions from the FDA Office of Combined Products. The firm’s 3/3 petition says that letter of designation decisions may be appealed to the associate commissioner of special medical programs, but there is no set timeframe within which the associate commissioner must act. Likewise, any subsequent appeals to the commissioner are not subject to timelines for review, the petition says. “This has resulted in significant delays in decision-making for which the agency has no accountability,” the law firm says.

The petition suggests that FDA amend its regulations so that initial and subsequent appeals complete their review within 60 calendar days of the appeal submission. It also asks that the agency decide by 3/9 all pending appeals of letters of designation that are under review and that were originally submitted before 10/1/15. “That will have provided FDA over 17 months to have considered an appeal, which seems more than reasonable…,” the letter says.

Consequences Epstein Becker Green attributes to delays in the appeals process include:

thwarting timely correction of errors in decision-making, allowing decisions to stand in violation of the Federal Food, Drug, and Cosmetic Act’s standards for designation of products and the Administrative Procedures Act;
thwarting of process changes that align with the 21^st Century Cures Act provisions for determining a product’s primary mode of action;
robbing innovators of patent life and pressuring them to go along with incorrect decisions; and
delaying and denying access to novel therapies.

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