January 27, 2016

Manchin to Filibuster Obama's Nominee for FDA Chief | Charleston Gazette-Mail

West Virginia Sen. Joe Manchin announced plans Wednesday to filibuster President Barack Obama’s nominee to head the Food and Drug Administration, saying Obama’s pick has close ties to the pharmaceutical industry and won’t be tough enough against opioid painkillers.

During a speech on the U.S. Senate floor, Manchin said the FDA needs a total overhaul, and Dr. Robert Califf, now second in command at the federal agency, won’t make that happen.

“I do not believe he is the leader we need to change the culture of the FDA and address the epidemic of prescription drug abuse that is ravaging West Virginia and our country,” Manchin said. “He will not have the impact or leadership capabilities that the nation needs to stem the tide of the opioid crisis.”

In recent days, three of Manchin’s Senate colleagues — Sen. Bernie Sanders, I-Vt., Sen. Lisa Murkowski, R-Alaska, and Sen. Ed Markey, D-Mass. — have placed a hold on the nomination, even though a Senate committee approved Obama’s selection earlier this month.

Manchin becomes the first senator to announce he plans to use a filibuster to block Califf’s nomination. A filibuster is stronger than a “hold,” which can be overcome by 60 votes.

Manchin vowed to “come to the floor and read letters” from West Virginians whose lives have been devastated by painkiller addiction.

“I will read letters from children who have seen their parents die from an overdose,” Manchin said. “I will read letters from grandparents who have been forced to raise their grandchildren when their kids went to jail, rehab and the grave. I will read letters from West Virginians who need help from the FDA.”

Senators have raised questions about Califf’s ties to the drug industry.

In 2006, Califf established a research group at Duke University that conducted numerous studies for the world’s largest drugmakers. More than half of the group’s funding came from the drug industry. Government ethics disclosure forms show Califf received consulting fees, travel, meals and other payments from drug companies — including opioid manufacturers — between 2010 and 2014, according to Manchin and an Associated Press report.

“The FDA and commissioner’s No. 1 priority should be public health, and it is inappropriate for the FDA commissioner to have had such close financial ties to the pharmaceutical industry,” Manchin said.

In late December, Manchin railed against the FDA, accusing the agency of working against a federal effort to curb the prescribing of painkillers.

FDA officials had spoken against new opioid prescribing guidelines drafted by the Centers for Disease Control and Prevention. The guidelines aim to reduce a nationwide increase in deadly prescription drug overdoses.

West Virginia has the highest drug overdose death rate in the nation. West Virginia reported 627 overdose deaths in 2014, up from 570 in 2013, according to CDC data released last month. Prescription painkillers contributed to many of those deaths.

Manchin said he recently met privately with Califf, who told him he didn’t have a plan to tackle opioid addiction. Califf also told Manchin he didn’t see any problems with the FDA’s handling of the nation’s prescription painkiller epidemic, the senator said.

Califf has described FDA regulation as a “barrier,” not a safeguard for public health, Manchin said.

“We need to change the FDA to make them address the crisis seriously,” Manchin said. “That will not happen if the person at the helm is not a strong advocate who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health.”

By:  Eric Eyre