Democratic senator blocks Obama’s pick to head FDA

Mary Clare Jalonick
Associated Press

Washington — A Democratic senator said Monday he is blocking President Barack Obama’s nominee to head the Food and Drug Administration as he pressures the agency to be tougher on abuse of opioid painkillers.

Massachusetts Sen. Edward Markey said in a statement that he has put a hold on the nomination of Dr. Robert Califf, the No. 2 official at the agency who was a prominent cardiologist and medical researcher at Duke University for more than 30 years.

“The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination,” Markey said. “Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”

Deaths linked to misuse and abuse of prescription painkillers climbed to 19,000 last year, the highest figure on record, according to the Centers for Disease Control and Prevention. By its estimation, deaths tied to these drugs have surged more than fourfold since 1999 amid increased prescribing by U.S. doctors.

Even though a Senate committee approved Califf’s nomination by voice vote earlier this month, Obama’s choice faced strong opposition for multiple reasons.

Sen. Lisa Murkowski, R-Alaska, said she would delay a vote in the full Senate until she had reassurances that FDA will write rules for labeling genetically modified salmon. She has said the engineered salmon approved by the FDA last year could be harmful to her state’s wild salmon industry.

Democratic presidential candidate Sen. Bernie Sanders said the country needs an FDA commissioner who will stand up to the pharmaceutical industry and that Califf is “not that person.” The Vermont independent said he was considering a hold.

Some Democrats have raised concerns about Califf’s ties to industry. In 2006, Califf founded the Duke University Clinical Research Institute, a contract research group that has conducted studies for virtually all of the world’s largest drugmakers. Government disclosure forms show that Califf received more than $29,000 in consulting fees, travel, meals and other payments from drugmakers in 2014.

Califf has already recused himself from dealing with certain companies to avoid conflicts of interest.

Tennessee Sen. Lamar Alexander, the Republican chairman of the Health, Education, Labor and Pensions Committee, is supporting the nomination.

As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations and food safety and labeling reforms.

Former FDA Commissioner Margaret Hamburg left the job early last year. The FDA’s chief scientist, Dr. Stephen Ostroff, is serving as acting head of the agency.