Tuesday, February 9, 2016

Sunday Globe Special: Tiff Over Califf

I'm not going to argue about it:

"Ed Markey blocks vote on FDA chief over opiate approvals" by Mark Arsenault Globe Staff  January 24, 2016

US Senator Edward Markey is using Senate rules to block the nomination of a proposed new leader of the US Food and Drug Administration in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices, Markey said in a Globe interview.

Using parliamentary procedures, the Massachusetts Democrat has put a “hold” on the nomination of Dr. Robert Califf, which prevents the Senate taking a confirmation vote, at least for the time being.

Markey, who has made the growing wave of opioid addiction one of his legislative priorities, is demanding that the FDA agree to reverse its 2015 decision allowing the pediatric use of the prescription painkiller OxyContin.

“It’s very clear to me the FDA has decided that . . . it will create big problems for them if they have any new advisory panels that vote against the approval of any of these new drugs or new uses,” Markey said.

At least we know what high-level dealer is allowing that stuff on the street.

Markey explained his decision to block the Califf nomination in a Dec. 21 letter to Sylvia Mathews Burwell, secretary of Health and Human Services. Burwell’s department, in a statement to the Globe, said that Califf is the right person to lead the FDA and the department wants him confirmed as quickly as possible.

Markey said Friday he had not yet received a response. “No one really understands how the FDA operates,” Markey said.

A frightening statement considering it his tasked with basics of like.

Nominations that require Senate confirmation can be pressure points in Washington politics, giving individual senators the leverage to advance their political causes.

A single senator can block a confirmation vote by placing a hold on it, though a hold can eventually be defeated if at least 60 senators vote to end the obstruction.

Markey is not the only senator seeking leverage with the Califf nomination: Senator Lisa Murkowski, an Alaska Republican, is also blocking a confirmation vote, her office said, for an entirely unrelated reason.

Murkowski wants assurances from the FDA that it will require mandatory labeling for genetically engineered salmon.

Does that mean it is not a biparti$an block? 

Who knows? 

Maybe it will be a better catch.

Another senator, Vermont independent Bernie Sanders, a candidate for the Democratic Party’s nomination for president, has suggested that he, too, may block a vote on Califf, because of the doctor’s ties to the pharmaceutical industry. A Sanders spokesman could not be reached for comment.

Taking them on might doom his campaign.

Dr. Sidney Wolfe, an expert on drug safety issues who served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2008 to 2012, said FDA decision makers are highly influenced by testimony about pain and the need for pain relief.

“I am a physician — I’m very concerned about the pain needs of people also,” said Wolfe, a founder and senior adviser of the Health Research Group at the nonprofit consumer rights advocacy group Public Citizen. “But if you start using opioids for things other than just people who have things like severe cancer pain and start saying it’s OK for moderate pain, you’re basically putting you’re blessing on opioid abuse.”

Public Citizen has urged the Senate to reject Califf’s nomination, citing Califf’s history of financial ties with drug and medical device makers....


RelatedEd Markey says FAA must do more to prevent drone-plane mishaps

Says he will deliver on that. 

Maybe this will bring Ed and the others back down to the ground:

"FDA to overhaul opioid policies. Will it ease concerns over Califf?" by Sheila Kaplan, February 4, 2016

WASHINGTON — Two of the four senators vowing to block or filibuster a confirmation vote have expressed concern over the FDA’s policies on opioids. Both Edward Markey of Massachusetts and his Democratic colleague Joe Manchin of West Virginia have criticized the agency for not doing more to address the nationwide epidemic.  Last month, Markey, said he was especially troubled that the FDA approved OxyContin for children in 2015 without first convening an expert advisory panel, as the agency often does, while Manchin took issue with Califf’s ties to the drug industry, including companies that make opioids.

The changes were met with skepticism by one expert. “If they really do reexamine the risk-benefit paradigm, it would be a game changer,” Dr. Andrew Kolodny, chief medical officer at Phoenix House, a nonprofit that runs drug abuse treatment and prevention programs, told STAT. “But it’s hard to know if they’re sincere about it.”

Not really. They lost any ability to convince of that long ago.

“There may be some public relations here,” Kolodny noted.


Indeed, the FDA’s move appears to address some of the issues that caused lawmakers to block Califf’s nomination. But it won’t be clear sailing for Califf.

“We have serious concerns with the proposal, even if it is a good start,” a spokeswoman for Markey said in an email. “Senator Markey will not be releasing his hold on Dr. Califf’s nomination as he doesn’t feel these proposals go far enough.”

In a recent move related to Senator Lisa Murkowski’s unease over Califf, the FDA revised its guidelines on genetically modified fish, now requiring such products to be labelled. A spokesman for Murkowski, an Alaska Republican, said she was still studying the issue.

If the three lawmakers do accept the recent FDA moves and free their holds on Califf, he still has one final faultfinder to win over: Bernie Sanders.

The Vermont Senator and Democratic presidential hopeful’s main issues with the FDA nominee: industry ties and rising prescription drug prices.

Among the FDA’s new plans to reverse the opioid epidemic are....

I quit.


Related: FDA rejects Vertex’s application for expanded use of drug

Happy now?

Also seeWhy the FDA shouldn’t bow to parental pressure over Duchenne drug