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 Presidential candidate Bernie Sanders was among the Democrats who
grilled Dr. Robert Califf, 64, who joined the FDA in January as a
deputy commissioner. If confirmed, Califf would oversee an agency
whose regulatory reach covers 20 cents of every dollar spent by U.S.
consumers and includes food, drugs, tobacco, dietary supplements and
cosmetics.
Califf previously held senior positions at Duke University, where he
founded a large academic clinical research center that received more
than half of its funding from the drug industry. Over the years,
Califf has led multiple large-scale company-funded clinical trials
and published more than 1,200 papers.
Responding to questions from Senator Elizabeth Warren of
Massachusetts, a Democrat, Califf told the committee that the
clinical trials he conducted at Duke, if funded by a drug company,
had "ironclad" contracts giving the investigators the final rights
to publication.
Sanders, a Democratic senator from Vermont, said that the FDA needs
a candidate who can stand up to an industry that has been "ripping
off" the American people by charging "outrageous" prices for
medicines.
"I have to say to you with regret that you are not that person,"
Sanders told the nominee during the hearing called by the Senate
Health, Education, Labor & Pensions committee. Sanders and other
critics say Califf's financial ties to the industry will prevent him
from impartially regulating it.
Politicians are scrutinizing the cost of prescription drugs
following revelations of extreme price increases for some old or
mediocre drugs charged by privately held Turing Pharmaceuticals,
Valeant Pharmaceuticals International and others.
"While all of us agree that clearly we want great new products out
on the market to save lives, for millions of people it doesn't
matter what the products are, they just cannot afford them," Sanders
said.
The committee will vote on whether to approve the nomination, which
must eventually be approved by the full Senate. Patient groups and
medical associations expect Califf to help speed new drugs to market
and have publicly backed him, making his confirmation widely
expected.
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The FDA faces pressure from lawmakers and patient groups to make it
easier for drug companies to bring new products to market.
The U.S. House of Representatives has passed a bill known as the
21st Century Cures Act that would require the FDA to consider more
flexible forms of clinical trials and incorporate patient experience
into its review process. A similar bill is being considered in the
Sentate.
Critics say the bills risk weakening the FDA's ability to ensure
drugs are safe and effective.
Califf said it is possible to develop a clinical trial system that
could be used to deliver better clinical trial results with larger,
more representative patient populations, at lower cost, by using
existing electronic health records.
"We've got to overcome some interoperability problems," he said,
"but we can do this."
Speaking after the hearing at an event organized by the patient
advocacy group Friends of Cancer Research, Califf said achieving a
balance between fostering drug innovation and protecting patient
safety is difficult.
"You've got to have an internal compass and dedication to the
mission," he said.
(Reporting by Toni Clarke in Washington; Editing by Andrew Hay and
Jonathan Oatis)
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