Nominee for US Food and
Drug Administration commissioner has deep ties to drug industry
By Brad Dixons
15 March 2017
15 March 2017
The Trump administration announced on Friday
that it intends to nominate Scott Gottlieb as the new Food and Drug
Administration (FDA) commissioner. Gottlieb has close ties to the drug industry
and, if confirmed, will work to roll back regulations at the FDA.
President Trump had
already made clear his wishes to eliminate most regulations at the FDA. After a
meeting with drug industry executives on January 31, Trump announced that
he wanted to get rid of 75 or 80 percent of FDA regulations, along with cutting
taxes on pharmaceutical companies.
“Our slow and burdensome approval process at the
Food and Drug Administration keeps too many advances…from reaching those in
need,” Trump said in his first address to Congress.
Gottlieb is a physician
and resident fellow at the conservative American Enterprise Institute. He is a
regular contributor to news outlets such as Forbes and the Wall
Street Journal. Unlike many of Trump’s nominees, he has some experience
with the agency he has been nominated to oversee.
He worked at the FDA under George W. Bush from
2003 to 2004 as a senior adviser to the FDA commissioner and director of
medical policy development, before moving to the Centers for Medicare and
Medicaid Services (CMS) where he helped implement the Medicare Part D drug
benefit. He returned to the FDA as deputy commissioner for medical and
scientific affairs from 2005 to 2007.
He also has close ties to the industry he will
be charged with regulating. Since 2007, he has been a venture partner at the
world’s largest venture capital firm, New Enterprise Associates (NEA), helping
the firm manage its health care investments. He is also a managing director at
the merchant and investment bank T.R. Winston & Company, and previously
served as a senior adviser for health policy at Arcoda Capital Management.
He has served on the boards of a number of
pharmaceutical and medical device companies, including GlaxoSmithKline, Glytech
and Tolero Pharmaceuticals. According to STAT News, he currently serves as an
adviser to GlaxoSmithKline, Cell Biotherapy and Bristol-Myers Squibb.
Between 2013 and 2015, Gottlieb received more
than $400,000 in consulting and speaking fees from pharmaceutical companies,
including Vertex, GlaxoSmithKline, Daiichi Sankyo, Pfizer, and Novo Nordisk,
according to CMS’s open payments data web site.
Michael Carome, director of Public Citizen’s
Health Research Group, was quoted by Chemical & Engineering News saying
that Trump’s pick “is entangled in an unprecedented web of Big Pharma ties. He
has spent most of his career dedicated to promoting the financial interests of
the pharmaceutical industry.”
“Gottlieb’s appointment would accelerate a
decades-long trend in which agency leadership too often makes decisions that
are aligned more with the interests of industry than those of patients,” he
said.
Diana Zuckerman, president of the National
Center for Health Research, a research advocacy group, said she was troubled by
the potential for conflicts of interest. “He’d clearly need to divest his own
stock and resign from the boards,” she told STAT News, “and unless he swore on
a stack of Bibles that he wouldn’t return to boards, investments, etc., it
would be a good example of the ‘swamp’ that Donald Trump promised to drain.”
“If [Gottlieb] is confirmed, he would be the
most interest-conflicted commissioner in American history, by far,” Daniel
Carpenter, a professor of government at Harvard and author of a history of the
FDA, told Vox.
Of the four individuals under consideration for
the position, Gottlieb was the preferred candidate of the biotech and
pharmaceutical industries, with 72 percent of biopharma executives favoring the
pick, according to a survey of 53 drug firms by Mizuho Securities. Pharmaceutical
executives had raised concerns that if drug approval regulations were rolled
back too drastically—as proposed by some of the other candidates—it would
become difficult to gain insurance coverage for costly medications.
“It could have been worse,” Gregg Gonsalves,
co-director of Yale’s Global Health Justice Partnership, told Vox. “Unlike many
of Trump nominees, he’s actually highly qualified to destroy the agency he’s
meant to lead.”
“We could have had a saber-toothed tiger
guarding the henhouse like Jim O’Neil, and instead we [may get] a
garden-variety fox at the helm,” he said.
The claim that
bureaucratic inefficiencies at the FDA are responsible for delaying the
approval of life-saving drugs, “where a culture of control strangles
innovation,” as a recent Wall Street Journal editorial puts
it, has little basis in reality.
FDA drug approval times have accelerated
dramatically in recent decades. The median review time for new drug approvals
has dropped from 27 months in 1993 to 10 months in 2016, according to data from
the FDA. The majority of new drugs take advantage of at least one of the
different expedited approval pathways offered by the agency.
Gottlieb’s extensive writings on health care and
drug regulation provide clues as to the priorities he will pursue at the
agency.
He wishes to streamline the approval process for
generics, which he argues has been hampered by unnecessary regulation, in order
to increase competition and drive down drug prices.
While there exists a backlog of applications for
generics, since the passage of the 2012 Generic Drug User Fee Agreement (GDUFA)
the median time for approval of generic applications, known as abbreviated new
drug applications (ANDAs), has fallen from 24 months in 2013 to 15 months in
2015. In 2016, more than 700 ANDAs were approved.
According to an article published by the
Regulatory Affairs Professional Society (RAPS) this past November, which drew
from an analysis by RBC Capital Markets, while there were 23 innovator drugs
with ANDAs awaiting a reply from the FDA, another 125 innovator drugs, which
had gone off patent and had no approved generics, had no ANDAs submitted
whatsoever.
“RBC data shows that the issue of a lack of
generic competition isn’t so much of an issue of FDA’s speed in bringing this
competition to market, but in industry submitting applications that would
create this competition,” said the RAPS article.
Last July, Gottlieb
penned an article for the Massachusetts newspaper South Coast Today in
which he praised the 21st Century Cures Act, which passed in December, for
allowing the wider use of “surrogate” measures and “adaptive” clinical trials
in which parameters are modified based on observations of biomarkers and
require smaller patient populations.
In a 2012 article for Health
Affairs, Gottlieb decried the FDA’s “increasingly unreasonable hunger for
statistical certainty” and “hunger for extreme certainty about how drugs work.”
He criticized the agency’s “culture of
mistrust,” which is “devoted to averting risks and protecting the public,” for
leading drug reviewers to “believe it is appropriate to prioritize safety over
speed.”
“In so heavily prioritizing one of its
obligations—the protection of consumers—the FDA has sometimes subordinated and
neglected its other key obligation, which is to guide new medical innovations
to market,” he wrote.
He also took the FDA to task for what he sees as
“a profound lack of confidence in the ability of doctors to make careful
judgments.”
“Reviewers believe that if the FDA does not use
its approval process to coerce reluctant sponsors into constructing exhaustive
studies—studies that extract every single kernel of potentially relevant
clinical information—then no one will ever adequately mine these data. And
because physicians cannot be fully trusted to do their jobs without this
information, and companies can’t be trusted to market drugs responsibly, the
FDA believes the delays caused by collecting such extensive data in prolonged
trials are worthwhile,” he wrote.
He argued that since junior staff at the FDA are
less willing to “embrace uncertainty,” approval decisions should be made by a
central committee of senior scientists who would, for example, be less
concerned with how doctors prescribe medications.
At a 2013 debate sponsored by Intelligence Squared
U.S., Gottlieb argued that the “FDA’s caution is, at times, hazardous,” because
of the agency’s “growing resolve to make sure the trials supporting drug
approval meet an arduous but increasingly outdated standard for proving
efficacy.”
“Americans deserve a less cautious FDA and an
FDA that actively embraces advances in science,” he said.
Gottlieb’s calls for easing the standards for
clinical trials and ignoring physician prescribing practices raise a number of
concerns.
First, doctors rely on the FDA to review the
clinical trial data—data that is often never made available to the public—to
determine that a drug is safe and effective for specific indications.
Second, doctors are allowed to prescribe
medications for uses not indicated on the FDA-approved label. In certain
settings, this practice can improve the standard of care and lead to
innovations in medicine. Around one fifth of all drug prescriptions are for
such “off-label” uses. However, a number of studies have found that doctors
often prescribe drugs for off-label uses that have little scientific support.
For example, according
to a 2006 article in the Archives of Internal Medicine,
73 percent of off-label drug mentions by physicians to patients had little or
no scientific support.
A 2009 survey of 1,200
primary care physicians and psychiatrists, published in the journal Pharmacoepidemology
and Drug Safety, found that 41 percent of the physicians mistakenly
believed that at least one drug-indication, with uncertain or no supporting
evidence, had been approved by the FDA.
“These results indicate an urgent need for
effective methods of disseminating information to physicians about the level of
evidence supporting off-label drug uses, with special attention to common
off-label uses known to be ineffective or to carry unacceptable risk of harm,”
the authors conclude.
A 2016 article published
in JAMA Internal Medicine, based on data from Canada, found that
off-label prescribing, especially for indications with little supporting
evidence, was associated with higher rates of adverse drug events.
One of the tasks faced
by the next FDA commissioner will be to provide guidance on the off-label
promotion of drugs. The recently passed 21st Century
Cures Act eases restrictions on the pharmaceutical industry
promoting drugs for off-label uses, allowing companies to avoid funding
expensive clinical trials for new indications. With Gottlieb at the helm, it is
likely that the FDA will codify this practice.
OBAMA-CLINTON-TRUMPERnomics:
America’s Road to REVOLUTION
….. but will they finish off the
American middle-class first???
“The Tax Policy Center finds
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million annually—repealing this investment tax would amount to an average tax
cut of $165,090.”
TRUMPERNOMICS: IMPLEMENTING SEVERE
OBAMA-CLINTONOMICS TO SERVE THE SUPER RICH!
“The Republican proposal builds on the
core features of
Obamacare, designed to boost the profits of the private
insurers and slash health care costs for the government and
big business.”
“The lifetime costs of Social Security and Medicare
benefits of illegal immigrant beneficiaries of President Obama’s executive amnesty
would be well over a trillion dollars, according to Heritage Foundation expert Robert
Rector’s prepared testimony for a House panel obtained in advance by Breitbart
News.”
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