FDA Policy/General

House Health Subcommittee Advances User Fee Bill

The House Energy and Commerce Subcommittee on Health 5/18 marked-up and advanced the FDA Reauthorization Act (FDARA) of 2017, that would reauthorize user fee programs for five years beginning 10/1. Four amendments were passed by voice, and they were offered by: Reps. Joseph P. Kenedy, III (D-MA), and Marsha Blackburn (R-TN); Reps. Larry Bucshon (R-IN), G.K. Butterfield (D-NC), and Susan Brooks (R-IN); Reps. Michael Burgess (R-TX), Gene Green (D-TX), and Leonard Lance (R-NJ); and Reps. Kurt Schrader (D-OR) and Michael Bilirakis (R-FL). One amendment would create an over-the-counter market for hearing aids, another would increase generic drug competition and provide 180-day exclusivity for generics where there’s a limited market, another would aim to protect the drug supply chain, and the last would look to improve medical device inspections.

“Let me be clear: if we do not have this bill to the President’s desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients,” said full committee chairman Greg Walden (R-OR).

Several Democrats urged the subcommittee to begin addressing drug pricing. “Throughout the country, and even from our president, there is bipartisan support for action to lower the costs of prescription drugs and make treatments more affordable for patients and their families,” Rep. Frank Pallone (D-NJ) said. Yet, despite this commitment from the president, this committee has yet to take serious look at what can be done to address the high costs of prescription drugs. I urge the chairman to hold a hearing on this issue, and to begin a process where we can work together in a bipartisan manner as we are today to learn more about what can be done to make prescription drugs affordable for patients and their families.”

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