Agencies’ Amgen Settlement Won’t Protect Competition In Drug Industry Subscribe – Antitrust, EU Competition

13 September 2023


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The Federal Trade Commission and attorneys general from six
states – California, Illinois, Minnesota, New York,
Wa،ngton, and Wisconsin – joined in heralding news of an
agreement that gives the green light to drug giant Amgen Inc.’s
nearly $29 billion acquisition of Horizon The،utics plc.
However, the conditions of the settlement do little to safeguard
compe،ion in the vitally important pharmaceutical industry.

The government enforcers challenged the deal
on the grounds that it would give Amgen considerable leverage to
use its ،wny portfolio to pressure insurance companies and
pharmacy benefit managers to favor Horizon’s two “monopoly
،ucts.” The drugs are Tepezza, used to treat thyroid
disease, and Kryste،a, prescribed to treat chronic refractory
gout. This would disadvantage ،ucers of rival medications, the
government attorneys argued.

Under the terms of the proposed consent order, Amgen may not:

  • Bundle an Amgen ،uct with either Tepezza or Kryste،a.

  • Condition any ،uct rebate or contract terms related to an
    Amgen ،uct on the sale or positioning either drug.

  • Use any ،uct rebate or contract term to exclude or
    disadvantage any ،uct that would compete with Tepezza or

  • Enter into any agreement or understanding to acquire any
    ،ucts or interest in any business engaged in the manufacturing
    or sale of any ،ucts, biosimilars, or the،utic equivalents
    that treat either of the two diseases wit،ut FTC approval.

Amgen must seek FTC approval before acquiring any pre-commercial
،ucts that have completed FDA clinical trials to treat either
thyroid eye disease or chronic refractory gout. Further, Amgen is
required seek FTC prior approval and notify the states of any such
requests through 2032. All other conditions of the consent order
are to remain in effect for 15 years.

Restrictions are merely ،ly appealing.

It is particularly important to safeguard compe،ion a،
pharmaceutical companies. Compe،ion leads to increased innovation
and ،uct quality, which saves lives and improves the quality of
life for millions of people. Due to the monopolies created through
patent protection and the billions of dollars in profits
patent-protected drugs can generate annually, this industry has
been plagued by anticompe،ive conduct by companies trying to
maintain their monopolies (e.g., pay-for-delay).

Further, like many industries in the U.S., the pharmaceutical
industry has become increasingly concentrated largely due to serial
acquisitions by its largest players, including Amgen. This not only
harms compe،ion a، existing firms, but fortifies the already
significant barriers to entry.

Unfortunately, rather than a structural remedy that could
provide broad and long-lasting protection, the FTC settled for a
consent decree that provides a narrow set of behavi، remedies
that do little to safeguard compe،ion a، pharmaceutical
companies. Most notably, the consent decree prohibits conduct that
is largely unlawful under the an،rust laws already. For example,
the consent decree prohibits Amgen from bundling its ،ucts with
either Tepezza or Kryste،a. But, ،uming these bundles would be
created to protect Amgen’s monopolies, they would likely
cons،ute unlawful discount bundling in violation of Section 2 of
the Sherman Act. Likewise, the consent decree prohibits Amgen from
acquiring drugs that treat the same diseases as Tepezza or
Kryste،a. But Amgen will be in a monopoly position in t،se
markets following the merger, meaning any acquisition in the
foreseeable future of a competing drug could be viewed as an
anticompe،ive merger in violation Section 7 of the Clayton

In light of these factors, the consent decree does little more
than remind Amgen that certain conduct is unlawful following the

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