|
 Speaking before the House Committee on Energy and Commerce on
Wednesday, FDA Commissioner Scott Gottlieb outlined a proposal under
which every addict who suffers a non-fatal overdose would be treated
with an opioid substitute, for long periods if necessary, or even
for life.
The United States is battling a growing opioid abuse epidemic that
claimed more than 33,000 people in 2015, more than any year on
record, according to federal data.
"I know this may make some people uncomfortable," Gottlieb said of
his proposal. Even so, he added, "FDA will join efforts to break the
stigma associated with medications used for addiction treatment."
Gottlieb's plan mirrors his recent proposal to reduce nicotine in
cigarettes while expanding access to potentially less harmful
nicotine delivery devices such as e-cigarettes. Both proposals
embrace an approach to substance abuse that aims to reduce harm
rather than insist on complete abstinence.
President Donald Trump is expected to declare the opioid epidemic a
national emergency this week, two months after declaring his
intention to do so. It is unclear whether such a declaration will be
accompanied by more funds to address the problem.
Gottlieb cited data from the state of Massachusetts that showed a
greater than 50 percent reduction in the risk of death from overdose
among those treated with methadone or buprenorphine after an
overdose.
This kind of data "has immense implications for insurers and
policymakers in deciding how to adopt these treatments," he said.
The FDA also plans to examine expanding the labels for existing
medication-assisted treatment for everyone who presents with an
overdose, based on data showing a reduction in deaths.
"Such an effort would be a first for FDA," Gottlieb said. "We
believe that granting such an indication in labeling can help
promote more widespread use of, and coverage for, these treatments."
Methadone, a decades-old drug originally introduced by Eli Lilly &
Co; buprenorphine, a 15-year-old drug sold in combination with
naloxone by Invidior Plc under the brand name Suboxone; and
naltrexone, a drug sold by Alkermes Plc under the brand name
Vivitrol, act in a way similar to opioids but without delivering the
"high" that leads to addiction. They are used to help addicts taper
off opioids.
[to top of second column] |
The FDA, Gottlieb said, will issue guidance for drugmakers to
promote the development of new addiction treatments and lay out the
agency's interest in "novel, non-abstinence-based" products.
The stigma around opioid alternatives, Gottlieb said, "reflects a
view some have, that a patient is still suffering from addiction
even when they're in full recovery, just because they require
medication to treat their illness."
Cathryn Donaldson, a spokeswoman for America's Health Insurance
Plans, which represents the insurance industry, said health plans
will review the labels once they are revised and released by the
FDA.
"We'll continue to work closely with state and federal regulators to
ensure we're taking a comprehensive, collaborative approach to
solving this crisis and getting patients the care they need to
recover from addiction," she said.
Senate Democrats on Wednesday introduced legislation calling for $45
billion to address the opioid crisis and urged President Donald
Trump and Republicans in Congress to support the bill, which would
provide funding for prevention, detection, surveillance and
treatment.
Purdue Pharma LP, which makes the opioid painkiller OxyContin, said
on Wednesday it is the subject of a federal investigation. The
company is battling a series of lawsuits from states accusing it of
deceptive marketing.
(Reporting by Toni Clarke in Washington; Editing by Bill Rigby and
Steve Orlofsky)
[© 2017 Thomson Reuters. All rights
reserved.] Copyright 2017 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
