- The Washington Times - Monday, February 22, 2016

President Obama’s pick to lead the Food and Drug Administration cannot be trusted to rein in and regulate prescription painkillers at the heart of a deadly U.S. epidemic, a pair of Senate Democrats said Monday, leveraging a floor vote on the nominee to elevate their fight against opioid and heroin abuse.

Sens. Joe Manchin III of West Virginia and Edward J. Markey of Massachusetts said Robert M. Califf is a “good man” but that his work as a drug company consultant and researcher who relied on funding from the industry makes him a poor fit during a crucial time.

They said the FDA for years has been too quick to ignore outside researchers and rubber-stamp new prescription painkillers. They also fumed when the agency authorized the use of OxyContin by children as young as 11.

“Enough is enough. This whole culture has to change,” Mr. Markey said.

Their lengthy remarks to reporters previewed a procedural vote late Monday on Dr. Califf that would clear the way for his confirmation this week.

Mr. Markey and Mr. Manchin said they would try their best to deny Dr. Califf the 60 votes his nomination needs to proceed, though they didn’t have a whip count and cast their outcry as a springboard for a yearlong fight that could bleed into the appropriations process.

“We’re going to wage our battle, but this is the beginning of a long struggle that I think, ultimately, we’re going to win,” Mr. Markey said.

Senate Majority Leader Mitch McConnell’s push to confirm Mr. Obama’s pick stands in stark contrast to the bitterly partisan battle over how to replace late conservative Supreme Court Justice Antonin Scalia. Republican leaders say the president should leave the nomination to the next president.

Yet lawmakers from both parties have sounded the alarm over the proliferation of opioid painkillers and heroin, which affect the body in similar ways and are causing thousands of overdose deaths.

The epidemic is forcing law enforcement and politicians to rethink their punitive crackdown on drug offenders and put treatment over prosecution. On Monday, Mr. Manchin said he wants to impose a fee on opioid manufacturers that will be used to fund drug abuse treatment centers.

Mr. Obama nominated Dr. Califf, the deputy FDA commissioner for medical products and tobacco, in September to be commissioner of the FDA, which regulates a quarter of all consumer spending, or $4 trillion per year.

The cardiologist’s nomination breezed through the Senate Health, Education, Labor and Pensions Committee, without dissent, on a voice vote in mid-January.

“I’ve seen nothing that calls into question his ability to lead the agency fairly and impartially,” Committee Chairman Lamar Alexander, Tennessee Republican, said at the time.

But several lawmakers raised questions about Dr. Califf’s tenure at Duke University, where he led a clinical research center that received a large share of its funding from the pharmaceutical industry.

Dr. Califf testified that the research center reached its scientific findings independently, though some senators, including Democratic presidential contender Bernard Sanders of Vermont, said his history at Duke and work as a consultant for large drug companies makes him the wrong candidate to rein in skyrocketing prescription drug prices, while others homed in on the opioid issue.

Sen. Lisa Murkowski, Alaska Republican, used the nomination to wage a fight of her own. She wants the FDA to reconsider its position on the voluntary labeling of genetically modified fish.

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