Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Feb. 5 — Key Senate Democrats said the FDA's new policies to address opioid abuse won't cause them to let the nomination of Robert Califf proceed.
A growing list of Democratic lawmakers, including Sens. Edward Markey (Mass.) and Joe Manchin III (W.Va.), have said they will oppose Califf's nomination to lead the agency because they think the FDA's oversight of opioid painkillers isn't strong enough. Specifically, the lawmakers said they want the agency to reverse its approval of a pediatric use for OxyContin.
Califf, who already is an FDA official, also faces opposition from Democratic presidential candidate Sen. Bernie Sanders (I-Vt.). Sanders said he is holding up the nomination because of Califf's close ties to the pharmaceutical industry and lack of commitment to lowering drug prices.
In a Feb. 5 blog post, Califf said FDA staff recognized that more needed to be done “to ensure that we’re appropriately taking into account the public health crisis that confronts us in the context of the role we play in ensuring the safety and efficacy of drugs.” Califf is currently the agency's deputy commissioner for medical products and tobacco, and a former researcher at Duke University.
The senators opposed to Califf's nomination said the plan was a small step in the right direction, but not enough to convince them to lift their respective holds.
“To its credit, the FDA has agreed to my request to reassess the way it considers the risks of addiction and misuse when it evaluates the safety of new opioids,” Markey said in a Feb. 4 statement. “While this is a good start, even more is required to ensure the FDA’s approval process protects Americans from the dangers of opioid painkillers.”
Califf faces bipartisan opposition. Republican Sen. Kelly Ayotte (N.H.) recently said she will join Markey in placing a hold on the nomination because of the agency's approval of OxyContin for kids.
Sen. Lisa Murkowski (R-Alaska) has also placed a hold on Califf, but because of concerns over the agency's approval of genetically engineered salmon.
Sidney Wolfe, founder and senior adviser of the Health Research Group at Public Citizen, a consumer advocacy organization, told Bloomberg BNA Feb. 5 the bipartisan opposition is important, because it means Senate Majority Leader Mitch McConnell (R-Ky.) may be reluctant to hold a vote when members of his own party object to the nominee.
McConnell “has to be prepared to have a discussion,” Wolfe said, because senators who have placed a hold will want to have their opinions heard. Still, Califf's confirmation is likely because senators can't filibuster a nominee and only 51 votes are needed. Outside of a handful of senators, Califf has broad support. Public Citizen opposes Califf's confirmation because of his ties to the drug industry.
A Senate committee approved Califf's FDA nomination in January by voice vote .
Some of the FDA's changes include convening an advisory committee to review new opioids without abuse-deterrent properties and for pediatric indications.
Markey and Manchin have been highly critical of the agency's lack of use of advisory committees when it comes to approving opioid medications, especially with regards to the pediatric approval of Purdue Pharma LP's OxyContin.
“The policy announced by the FDA would not have guaranteed an advisory panel for the OxyContin on the market today, or the two other recently-approved opioids—Hysingla and Targiniq—that have raised serious concerns from public health and medical experts,” Markey said. “The FDA needs to welcome outside expert advice and must convene expert advisory committees for all opioid approval decisions, period.”
Manchin credited the agency's decision “to finally start listening to the advice of its expert advisory committees.” However, he said the FDA should use the advisory committees' expert advice “for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids.”
Manchin said the FDA also needs to “commit to adhering to the recommendations that the advisory committee puts forward. In the past, I have been so frustrated with the FDA’s reluctance to accept its own advisory panels’ recommendations.”
Manchin specifically referenced Zohydro, a pure hydrocodone painkiller manufactured by Zogenix Inc. The FDA overruled its own advisory panel when it approved Zohydro in 2013. The agency's advisory committee voted 11-2 against approval.
Wolfe said he thinks the agency's policy change was made in order to try to appease Califf's detractors, and it still isn't nearly strong enough.
“If this issue is so important, why did they have to wait until someone put a hold [on Califf]?” Wolfe said. “Why didn’t it happen two, four, six months ago? This isn’t a new problem.”
During a Feb. 4 conference call announcing the policy changes, Califf addressed the pressure from lawmakers but didn't specifically mention the senators' holding up the confirmation.
“We heard what Congress had to say,” Califf said. “That kind of pressure, when it's put on for general policy issues, helps us think. So we stepped back and thought about it”.
No vote on the nomination has been scheduled.
To contact the reporter on this story: Nathaniel Weixel in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
A fact sheet on FDA's policy is at http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)