Pubdate: Tue, 10 Jan 2017
Source: Milwaukee Journal Sentinel (WI)
Copyright: 2017 Journal Sentinel Inc.
Author: Ike Brannon, Devorah Goldman


It is time to take a second look at reforming the opioid market, starting
with the regulatory environment.

[photo] Ike Brannon and Devorah Goldman of Capital Policy Analytics argue
that it's time to reform the opioid market, starting with the regulatory
environment. Capital Policy Analytics is a Washington, D.C., based
consulting firm that provides economic analysis to businesses regarding
how government policies affect markets and the broader economy.(Photo:

Attorneys general from nearly every state and across the political
spectrum agree that the makers of the drug Suboxone, a widely used
treatment that reduces cravings for opiate addicts, violated state and
federal antitrust laws.

In the process, they have unnecessarily inflated the price of Suboxone and
undermined security in prisons all over the country. Most critically, at a
time when the nationwide opioid crisis has reached epidemic proportions,
they have made it more difficult for patients to access a range of
effective treatments.

Forty-two states have joined in a lawsuit against Indivior and MonoSolRX,
alleging that the companies manipulated patent laws and U.S. Food and Drug
Administration regulations in an attempt to prevent competition from
entering the marketplace -- a strategy that has been very successful for

The lawsuit, Wisconsin vs. Indivior Inc. et al., accuses the drug
companies of "product hopping," or making non-medical changes to an
approved medical product in order to stifle competition. In this case,
Indivior received FDA approval in 2002 for an opioid dependency treatment
(buprenorphine/naloxone) that came in tablet form and for which they were
granted market exclusivity for seven years.

During that time, Indivior stopped producing the tablets (based on
disputed safety concerns not evaluated by the FDA) and began producing a
dissolvable oral strip instead. The FDA approved the patented strip
version of Suboxone in 2010, leaving potential generic competitors unable
to actually compete: The strip is not an exact pharmaceutical equivalent
of the tablets, so there is currently no drug on the market for generic
brands to duplicate.

Naturally, this has led to inflated prices for Suboxone. And in Wisconsin
and elsewhere, the strips are one of, if not the only, treatment of this
type covered under Medicaid. Alleging that Indivior's safety concerns were
baseless and that its refusal to continue producing Suboxone in tablet
form violated antitrust laws, the various attorneys general intervened to
get cheaper and more accessible versions of buprenorphine, in tablet form,
to market.

Bringing a greater variety of options for this treatment to patients is
important not only because it would help combat the growing opioid
epidemic in a number of states, but because Suboxone strips are easy to
conceal -- a feature that has spawned an extensive black market in

In Wisconsin and other states, law enforcement officers have uncovered
contraband in the form of Suboxone strips being slipped in -- via books,
clothes and other items -- and abused in prison. In Maryland, Suboxone was
the leading contraband item found in correctional facilities: It has been
called "the king of the jailhouse drug trade." Diversifying the market
with options that are less likely to be diverted to a black market is key
to reducing this problem.

Last July, President Barack Obama signed the Comprehensive Addiction and
Recovery Act of 2016 into law, signaling a bipartisan, nationwide
recognition that our approach to addiction needs to change. The law
contains a number of initiatives designed to expand treatment options and
availability, but does not address potentially anticompetitive actions by
drug companies.

The opioid epidemic is hurting those who struggle directly with the pain
of addiction, and it is unnecessarily hurting taxpayers due to the woeful
lack of options and associated costs. It is time to take a second look at
reforming the opioid market, starting with the regulatory environment that
paved the way for companies to effectively block competition.

Ike Brannon is president and Devorah Goldman is director of health policy
research at Capital Policy Analytics, a Washington, D.C.,-based consulting
firm that provides economic analysis to businesses regarding how
government policies affect markets and the broader economy.
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