Transcript Jeanne Ireland Presentation

Abuse-Deterrent
Opioids:
FDA’s Role and
Emerging
Challenges
Jeanne Ireland
Principal, Ireland Strategies, LLC
2015 CWAG Annual Meeting
The Opioid Epidemic


Some progress being made, but devastating effects of epidemic continue

Each day, 44 Americans die from overdoses of prescription painkillers, including opioids

In 2013, nearly 2 million Americans abused prescription pain medications and more than
16,000 died

In five of the western states, over 80 painkiller prescriptions are written per 100
residents – the second highest rate in the nation. Even in those western states with the
lowest national rates, 50-70 prescriptions are written per 100 residents

2012 was the first drop/leveling off of prescription overdose deaths since the 1990s
AGs and States have played a leading role in addressing opioids abuse and
overdose

Use of a broad range of approaches, including prescription drug monitoring programs,
naloxone access, cracking down on “pill mills,” advocacy for abuse-deterrent
technologies

Introduction of legislation in 31 states this year alone relating to abuse-deterrent
opioids
Abuse-Deterrent Opioids – a
New Tool for Reducing Abuse

Abuse-deterrent opioids (ADOs) – opioids in formulations that are designed to
deter abuse by one or more routes

“Abuse-deterrent” = more difficult to abuse, not abuse-proof

Current products have properties that deter abuse, including
through the often lethal routes of snorting or injecting

May never be able to completely prevent abuse since product
has to deliver pain relief to patient – current products can still
be abused by swallowing more pills than prescribed

But, still an important element of a comprehensive strategy
for reducing misuse and abuse

Shift in landscape – now technological, as well as medical, law-enforcement,
and policy tools available

Emergence of ADO products presents new challenges for policymakers,
including standard-setting, labeling, data, access, and cost
The Federal Role in
Combatting the Epidemic
Many agencies with different mandates related to opioid abuse,
including:

Office of National Drug Control Policy– education and training

Department of Justice/Drug Enforcement Agency – oversight of
controlled substances, enforcement

Department of Health and Human Services

National Institutes of Health/National Institute on Drug Abuse - research

Centers for Disease Control and Prevention – epidemiological studies

Substance Abuse and Mental Health Services Administration/Indian
Health Service/Veterans Administration/Bureau of Prisons – provider
education, support for PDMPs

Centers for Medicare and Medicaid Services- coverage, oversight of
utilization

Food and Drug Administration – drug approval standards, labeling and
other safety measures
FDA’s Role in Regulating
Opioids

Sets standards for the approval of opioids, i.e., what type of data is required
to demonstrate safety and effectiveness, analysis of risks vs. benefits

Sets standards for the approval of brand and generic ADOs – additional element
of assessment of AD properties

Can require drug manufacturers to develop education materials and train
practitioners on appropriate use and to conduct postmarket studies

Determines what “labeling” a drug will carry

Informs patients, providers, and payors for which conditions/uses the drug is approved,
how it should be used, safety information

Determines the type of claims that can be made by drug sponsor in marketing and
promoting the product

Can mandate changes to labels of approved products if FDA becomes aware of new
safety information
FDA’s Regulation of ADOs:
Multiple and Competing
Considerations
FDA’s vision: “…a future in which most or all
opioid medications are available in formulations
that are less susceptible to abuse than the
formulations that are on the market today.”

Incentivize ADO development

Incentivize progressively stronger AD properties
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Set realistic expectations about limitations of
current technologies
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Ensure access to lower-cost generics

Maintain access to pain relief for patients in need
Current FDA Efforts

Since 2010, approved four opioids with AD properties

In 2012, required manufacturers to educate providers and patients on
appropriate prescribing and safe use

In 2013, ordered safety changes to labels of certain opioids to clarify their use
for severe pain and for patients for whom other lower-risk pain medications are
not appropriate. Also required manufacturers to conduct additional postmarket
studies

Issued guidance for the evaluation and labeling of branded ADOs (draft in
January 2013, final in April 2015) -- sets the bar for types and strength of data
needed to achieve progressively stronger AD labeling
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Laboratory testing
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Pharmacokinetic studies
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Human abuse potential studies
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Postmarket data on effect in real-world setting
Remaining ADO Policy
Decisions For FDA

Setting the bar for approval of generic ADOs – guidance expected as
soon as this year

Refuse approval of new opioids without AD properties?

Withdrawal of existing products without AD properties?

Additional labeling?
Complexities

Bar will keep shifting as technologies improve

Continuing need for data
Remaining ADO Policy Decision
Outside of FDA’s Purview - Access

Reimbursement decisions by payors, including CMS, can
impact patient access to ADOs

Recent study by Avalere found Medicare Part D plans
place greater restrictions on patient access to ADOs
than to non-abuse-deterrent generics opioids

Considerations

Cost
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Need for data
Conclusions
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Goal remains the same – reduction in abuse

ADOs offer an important new tool, but much
more needs to be done

Critical policy decisions still ahead offer
opportunities for continued engagement