Responding to the Opioid Epidemic: Legal Developments and FDA’s Role




Legal Sidebari

Responding to the Opioid Epidemic: Legal
Developments and FDA’s Role

Updated March 6, 2018
According to the Centers for Disease Control and Prevention, “115 Americans die every day from an
opioid overdose,” and deaths from prescription opioids have more than quadrupled since 1999. The
epidemic’s origins are complex, with fingers pointed at pharmaceutical manufacturers and distributors,
addicts and dealers, health care professionals, and insurance companies. Like the causes of the opioid
epidemic, any solutions to the problem will likely involve many actors, including the federal government.
The Food and Drug Administration (FDA)—the executive agency charged with protecting the public
health
by ensuring the nation’s drug supply is safe and effective—has developed an “opioids action plan,”
discussed in more detail below. Nonetheless, questions remain as to what actions the agency should take
and whether the agency’s existing authorities are adequate for addressing the crisis. This Sidebar provides
an overview of FDA’s existing authorities, the historical context for the opioid epidemic, and the
agency’s current plan for combatting the opioid epidemic, concluding with an examination of the broader
legal questions concerning the crisis.
Background. FDA is authorized by the Food, Drug, and Cosmetic Act (FD&C Act) to regulate the
nation’s drug supply both prior to and after marketing. Before a new drug product can be legally marketed
in the United States, a manufacturer must obtain FDA approval of a new drug application (NDA). When
considering an NDA, FDA conducts a risk-benefit assessment based on clinical evidence submitted by the
drug manufacturer showing that the underlying product is safe and effective for its intended use. New
drug applicants must also comply with labeling and manufacturing requirements, such that drug products
are not adulterated or misbranded. After approval, the FD&C Act requires FDA to monitor drugs to
ensure that they abide by FD&C Act requirements, including prohibitions against adulteration and
misbranding. Additionally, in 2007, the Food and Drug Administration Amendments Act authorized FDA
to require manufacturers to undertake Risk Evaluation and Mitigation Strategy (REMS). A REMS is a
safety strategy designed to manage a known or potential serious risk associated with a medicine. For
example, as part of a REMS, drug manufacturers may be required to provide certain information to
patients and/or health providers or impose restrictions on a product’s distribution. FDA may require a
REMS as a condition of a product’s approval, or the agency may impose a REMS on a product it has
already approved when new safety information arises. FDA enforces these requirements through a variety
of legal measures, including administrative actions, criminal and civil penalties, injunctions, and product
seizures.

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FDA’s task to ensure the safety and efficacy of drugs is particularly difficult with respect to regulating
opioids. Throughout recorded history, societies have struggled with balancing the medicinal use of
opioids in pain management with the concomitant euphoric effects that have induced the substance’s
abuse. Sixty years ago, the head of surgery at the University of Illinois noted, “we must appreciate that
severe constant pain will destroy the morale of the sturdiest individual. . . But. . . we are often loathe to
give liberal amounts of narcotics because the drug addiction itself may become a hideous spectacle.” As
a result of these difficulties, for
nearly a century, opioid pain medications were used in the United States
primarily to treat acute and cancer-related pain. But, studies from the 1970s revealing inadequate
management of chronic pain, followed by highly influential articles published in the 1980s reporting a
low incidence of addictive behavior in small groups of cancer and non-cancer patients, led to a trend
toward more liberal prescribing of opioids within the medical community. The shifting views on the
safety and efficacy of opioids culminated in FDA’s 1995 approval of Purdue Pharma’s controlled-release
opioid pain medication, OxyContin, the product some point to as the catalyst for the current opioid
epidemic. Between 2000 and 2009, the medical community established new standards for pain
management, which included pain as a new vital sign, and prescriptions for opioids increased. By 2016,
an estimated 11.5 million Americans were abusing prescription painkillers. And, in 2015 alone, over
33,000
people died due to a drug overdose involving an opioid.
FDA’s “Opioid Action Plan.” To combat the epidemic, on February 4, 2016, FDA announced its “opioid
action plan” that uses the agency’s existing authorities, both pre- and post-market, to “reduc[e] the impact
of opioid abuse on American families and communities.” The agency’s plan includes:
 consulting with an advisory committee prior to approving an NDA for an opioid without
abuse-deterrent properties;
 developing additional warnings and safety information for certain opioid labeling;
 strengthening post-market requirements to require, for example,
the study of the long-term effects of using extended-release/long-acting opioids;
 updating the REMs program, such as by requiring sponsors to fund continuing medical
education for prescribers;
 expanding access to abuse-deterrent formulations (ADF) of opioid medications by issuing
draft guidance on the agency’s recommendations for approving such drugs;
 supporting better treatment for opioid abuse, such as expanding access (e.g., over-the
counter availability) to overdose treatments and opioid alternatives; and
 reassessing the risk-benefit approval framework for opioid use to account for the current
understanding of the risks associated with opioid use and misuse.
FDA has since begun implementing this plan. For example, in March 2016, FDA announced that it would
require enhanced safety warnings for immediate-release opioid medications related to misuse, abuse,
addiction, overdose, and death. Last September, the agency announced the extension of manufacturer-
provided training requirements
for prescribers to other healthcare providers, such as nurses and
pharmacists. And, in November the agency issued a guidance document for industry articulating the
approval standards for generic opioid ADFs.
Broader Legal Issues Concerning the Opioid Epidemic. The announcement of FDA’s opioid action
plan takes place against the backdrop of broader legal questions arising from a wave of lawsuits
concerning the opioid epidemic. A growing number of state and local governments have filed suit against
the manufacturers and distributors of opioid pain medications. On December 6, 2017, the United States
Judicial Panel on Multidistrict Litigation (JPML) issued an order centralizing 64 actions that were
pending in nine different federal courts in the Northern District of Ohio. In turn, that court is to resolve


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any common questions to all of the suits prior to any trial. The JPML has already been notified of 115
potentially related actions that may ultimately be included in the multi-district litigation (MDL).
A number of the lawsuits included in the MDL are directed at several major drug manufacturers and seek
damages resulting from the opioid epidemic. The plaintiffs’ legal claims are based on a wide range of
federal and state laws, including state common law, such as “public nuisance, negligence, negligent
misrepresentation, fraud and unjust enrichment” claims. Manufacturers have argued in response that FDA
approval of the safety of a drug and its labeling preempts any state law claims contending that the drug is
unsafe. Notably, in a 2009 case, Wyeth v. Levine, the Supreme Court held that FDA approval of a brand-
name
drug does not shield the manufacturer from liability under state tort law. However, in 2011, in
PLIVA v. Mensing and two years later in Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court
concluded that the FD&C Act does preempt similar state law tort claims lodged against generic drug
manufacturers because federal law prohibits generic drug manufacturers, unlike brand-name
manufacturers, from making unilateral changes to the FDA-approved warning on a drug label. And in an
earlier case, Buckman Co. v. Plaintiffs Legal Committee, the Court suggested, but did not definitively hold
that even violations of the FD&C Act cannot support state common law claims. The open question for
many of the opioid lawsuits is whether the Supreme Court’s preemption case law forecloses the plaintiffs’
common law claims.
The possibility that FDA-approval could shield opioid manufacturers from liability begs additional
questions as to whether FDA can withdraw approval for certain opioid medications. The FD&C Act
authorizes FDA to withdraw approval of an approved NDA when, among other things, there is new
clinical evidence showing that the product is unsafe for its approved use. FDA must first provide the
manufacturer with notice that the agency is proposing to withdraw approval and an opportunity for a
hearing on the merits. However, the Secretary of Health and Human Services may suspend new drug
approval immediately if it is determined that the product poses an immediate hazard to the public health.
Although it is not a common occurrence, it has been estimated that FDA has withdrawn approval of
approximately 600 new drug and abbreviated new drug applications.
FDA has signaled its willingness to withdraw approval of products with serious potential for abuse. Last
June, FDA requested that Endo Pharmaceuticals recall from market Opana ER— a potent painkiller
reformulated to make it difficult to crush and snort. Although the product was intended to curb opioid
abuse, it reportedly led to the largest HIV outbreak in Indiana history when addicts resorted to liquidizing
and injecting the drug with shared needles. Because FDA does not have mandatory recall authority over
drug products— the agency can compel manufacturers of other products, such as foods and medical
devices
to recall— FDA’s recall announcement included the proviso that if the company did not comply,
FDA would begin procedures to have the product removed from market through the formal withdrawal of
approval. Ultimately, the company announced in July that it would comply with FDA’s request.
FDA’s regulations also provide the opportunity for concerned citizens and organizations to request that
the agency take certain actions, including withdrawing approval for drugs. Utilizing this authority, last
August, a group of public health officials and physicians petitioned FDA to withdraw approval of ultra-
high dose opioid pills and nasal sprays. Others, including the American Academy of Pain Management
have argued that withdrawal of approval is too drastic a step to take and would unduly harm those with
severe pain, including end-of-life patients. Under agency regulations, FDA has 180 days to respond to the
petition. In so doing, the agency may have to grapple with the broad question that underlies the
epidemic— how to strike the right balance between pain management and the risk of abuse. In the
meantime, Members of Congress, in considering that same broad question, have introduced several bills
that would, if enacted, alter the FDA’s authority over opioids, including by altering the approval process
for opioid NDAs (S. 1078) and encouraging the development of opioids with abuse-deterrent technologies
by altering the scope of marketing exclusivity for such products (H.R. 2025).


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Author Information

Kathryn B. Armstrong

Legislative Attorney




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