Forest, Maker of Celexa, Settels Marketing Claims

BOTOXのoff-label useを宣伝(off-label marketing)した件で$600 millionの賠償金を支払ったAllerganに引き続き、Forest Laboratoriesも同種の係争関係で$313 millionの賠償金を払うことに。

今回問題となったのは、CelexaとLexapro(S-enantiomer of Celexa)、そしてLevothroidの三商品。

■ Celexa

(S)-(+)-citalopram

SSRI, antidepressant.
Originally created in 1989 by Lundbeck.
Approved for adults over the age of 25. (Suicidality is concerned for those under 25.)

■ Levothroid

Synthetic form of thyroxine.
A hormone replacement given to patients with thyroid problems, i.e. hypothyroidism.

When it was originally launched in 1955 as Synthyroid, FDA did not approve it because it was "generally regarded as safe".
However, after it was shown that little difference existed between Synthroid and its generic brands in the 1990s, all levothyroxin prescriptions were required to undergo the formal FDA approval process.
Synthyroid was approved by the FDA on 24 July 2002.

昨年のPfizer($2.3 billion for misbranding Bextra)、一年前のEli Lilly($1.4 billion for misbranding Zyprexa)に続く調停の形だが、その賠償額には大きな差がある。
これはOn-lableとOff-labelを合わせた、薬剤の売り上げ、そして民事訴訟の際には原告側の被害の度合いなどが異なったためだと考えられる。

最後に、アメリカ司法省最大額となったそれぞれの調停について、原告側のコメントをかいつまんでまとめる。

■ Pfizer to Pay $2.3 billion for Fraudulent Marketing

“Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars.
This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

Tony West, Assistant Attorney General for the Civil Division

“This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs.”

Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky.

Boldで表記した辺りが一番のポイントだと思われる。

“The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes.
Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated.”

Mike Loucks, acting U.S. Attorney for the District of Massachusetts.

 ここいらも、額の大きさに影響している模様。

■ $515 Million Criminal Fine is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 million

"The illegal scheme used by Eli Lilly significantly impacted the integrity of TRICARE, the Department of Defense's healthcare system.
This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system.
Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its partners in law enforcement to investigate and prosecute those that abuse the government's healthcare programs at the expense of the taxpayers and patients."

Ed Bradley, Special Agent-in-Charge, Defense Criminal Investigative Service

Pfizerの際とコメントはほとんど同じ。
上に挙げたTRICARE関連の発言もPfizerの調停時に見られた。

世界のメガファーマでも、これらの係争で挙げたような違法プロモーションを行わないと、その地位が揺るいでしまうのが製薬業界かと思うと、日々一生懸命ながらぬくぬく研究所生活を送る自分とは温度差を感じてしまう。