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 Markey wants opioid-approval matters to be reviewed by an FDA
advisory committee and believes the committee should consider the
risk of addiction and abuse during the approval process. He also
wants the agency to rescind approval of OxyContin for children and
convene an advisory panel to guide that process.
"Last year, the FDA approved a new pediatric use for OxyContin
without convening an advisory committee even though its guidelines
note that FDA decisions that relate to controversial issues or
matters relating to children are particularly well-suited to
advisory committee empanelment," Markey said in a statement.
A "hold" is a procedure by which a senator can prevent a measure
from being voted on by the full Senate.
The nominee, Dr. Robert Califf, a cardiologist and researcher, is
widely expected to be approved when the Senate votes on the
nomination later this year, although critics argue his ties to the
pharmaceutical industry are too close.
 A spokesman for the Department of Health and Human Services, which
oversees the FDA, said it had made addressing the opioid crisis "a
top priority."
"Work at FDA and across HHS will continue on this important effort,"
spokesman Kevin Griffis said in a statement. "HHS will be in touch
directly with the Senator regarding his concern."
The Senate Committee on Health, Education, Labor and Pensions voted
earlier this month to confirm Califf as FDA commissioner, a position
open since Dr. Margaret Hamburg stepped down last February.
Califf, who joined the FDA a year ago as a deputy commissioner,
previously held senior positions at Duke University, where he
founded a large academic research center that received more than
half its funding from the drug industry.
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He has also led multiple large-scale, company-funded clinical trials
and published more than 1,200 papers. His interest in streamlining
the clinical trial process dovetails with those of patient groups
and members of Congress who are eager to see new drugs brought to
market faster.
U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5
percent to 47,055, propelled by prescription painkiller and heroin
abuse, according to the U.S. Centers for Disease Control and
Prevention.
Drug overdoses are seen as a major contributor to recently rising
death rates among middle-aged white Americans.
Since 2000, deaths from powerful, highly addictive opioids have
jumped 200 percent, the CDC said, with those addicted to
prescription painkillers, such as hydrocodone, increasingly turning
to widely available, often cheaper heroin.
(Reporting by Toni Clarke in Washington and Bill Berkrot in New
York; Editing by Jonathan Oatis and Peter Cooney)
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