FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

Posted 19 February 2016 By Zachary Brennan

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Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday.

Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s approval of the use of OxyContin for pediatric patients.

“Despite a raging prescription drug and heroin epidemic, the agency responsible for the safety of all prescription drugs in the United States is dismissing expert advice from doctors and other public health professionals by not convening advisory panels or overruling expert panel recommendations. The FDA must commit to shift the way it approaches and evaluates opioid addiction before I can consider supporting Dr. Califf’s nomination,” Markey said on Feb. 11.

“Senator Manchin believes that, with his long-term, significant ties to the pharmaceutical industry, Dr. Califf is not the champion the FDA needs to tackle this deadly epidemic, especially given the FDA’s failure to seriously address the prescription opioid crisis and properly weigh the risk of addiction and overdose death when approving ever stronger and more dangerous opioid drugs,” he said in a statement.

Last week he also introduced the Changing the Culture of the FDA Act, a bill to expand FDA’s mission statement to require that it address the nation’s opioid epidemic. Democrat presidential candidate Bernie Sanders also said he would oppose Califf’s nomination because of his ties to industry.

Back in January, Califf earned bipartisan support for his nomination from the Senate Committee on Health, Education Labor & Pensions and Sen. Lisa Murkowski (R-AK) has since dropped her opposition.

Monday’s vote will be the first for an FDA commissioner nominee in almost seven years, when Margaret Hamburg was cleared and then served for almost six years. Stephen Ostroff has been the acting commissioner since April 2015.

New FDA Meetings

As part of a concerted effort to address opioids, FDA announced that on 1 March, its Science Board will meet to discuss: (1) The role of opioids in pain management; (2) scientific challenges facing FDA in supporting the development of pain medications, including opioids, that have reduced risks of being abused; (3) scientific challenges facing FDA in understanding the real-world use of opioids to treat pain; (4) the role that FDA plays as a part of a federal, state and local response to the challenges of providing pain treatment while reducing opioid abuse; and (5) postmarket surveillance of opioids.

In addition, the agency also announced two meetings of the Pediatric Advisory Committee (PAC) that relate to the use of prescription opioids in pediatric patients, which are part of its opioids action plan.

The April meeting of the Pediatric Advisory Committee will discuss the proposed framework for the September discussion and will include an open public hearing.

The meeting in September will bring together experts from the FDA’s Pediatric Advisory Committee, Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. Experts will discuss the development of high-quality evidence to guide treatment, pediatric labeling for opioids, and improving practice to reduce addiction, misuse and abuse. The FDA has opened a docket for public comment.

FDA is also calling on independent experts with real-world experience to provide recommendations on how to address the unique needs of children in pain. Agendas and additional meeting background material will be available approximately two days before each of the meetings.

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Categories: Crisis management, Compliance, Postmarket surveillance, Product withdrawl and retirement, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: opioids and FDA, Califf, Senate vote for Califf, Manchin, Markey, Bernie Sanders

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