FDA Policy/General

Ways to Improve FDA Advisory Committee Process

Three Harvard Medical School researchers say there are steps FDA could take to become more consistent in its use of advisory committees to increase public confidence in the agency’s regulatory processes. Writing in the New England Journal of Medicine, the researchers say advisory committees can do more than provide the agency with additional information on a drug or medical device. “Advisory committees can also be seen as an indispensable part of science-led governance,” they write. “When an advisory committee provides its recommendations, it offers FDA a chance to legitimize a decision by engaging in transparent deliberation with experts from outside the political umbrella under which it works. Under this broader view, the value of advisory committee recommendations, even if FDA ultimately disagrees with them, lies in forcing the agency to make its reasoning plain and in engaging the public in the process.”

The authors suggest that FDA:

issue a guidance explaining how it decides whether to convene advisory committees, for example, with accelerated approvals;
publish in advance the questions it plans to ask advisory committee members and develop a standardized question structure for considering the approval or authorization of a medical product; and
establish a procedure for publicly explaining regulatory decisions that run contrary to advisory committee recommendations.

“If the agency does not implement these practices itself,” the article concludes, “Congress can consider legislation requiring these changes. Such reforms would not limit FDA’s authority to seek expert advice or to ask any additional questions it deems appropriate, but rather set minimum requirements for certain decisions. FDA does not always have to agree with its advisory committees. Regulatory decisions lie with the agency, not its advisors. But advisory committees cannot support public trust in FDA decisions if the agency uses them inconsistently. By committing to simple reforms, FDA can better leverage expert recommendations to improve accountability, transparency, and trust.”

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’

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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