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3.3 MB

Extraction Summary

2
People
4
Organizations
0
Locations
7
Events
3
Relationships
3
Quotes

Document Information

Type: Congressional report/oversight document
File Size: 3.3 MB
Summary

This document, from a House Oversight file, details the business practices of the pharmaceutical company Celgene concerning its drugs Thalomid and Revlimid between 2000 and 2017. It outlines allegations of improper 'off-label' marketing, significant price increases, and aggressive strategies to extend its patent monopoly and block competition from generic drug makers. The document includes quotes from a Celgene executive, a federal regulatory agency, and a generic drug industry representative.

People (2)

Name Role Context
Mr. Hugin Top executive at Celgene
Repeatedly referred to Thalomid and Revlimid as key to Celgene's financial future. Quoted from a 2004 investor confer...
Michael Brzica Vice president for federal government affairs at the Association for Accessible Medicines
Quoted as saying Celgene has gone to great lengths to protect its drug monopoly by building 'walls' around it.

Organizations (4)

Name Type Context
Celgene
Pharmaceutical company that markets Thalomid and Revlimid. Accused of improper marketing, settling a lawsuit in 2017,...
the agency
A federal regulatory agency (implied to be the FDA) that issued a formal warning letter to Celgene in 2000 for improp...
Association for Accessible Medicines
The lobbying group for the generic drug industry.
HOUSE_OVERSIGHT
Appears in the footer of the document, suggesting it is part of a file from the House Oversight Committee.

Timeline (7 events)

2000
A federal agency issued a formal warning letter to Celgene for improperly marketing Thalomid.
Celgene the agency
2001
Celgene reported that 92 percent of Thalomid's prescriptions were being written to treat cancer, despite lack of formal approval for those uses.
2004
Mr. Hugin spoke at an investor conference, calling Thalomid the company's 'financial engine'.
2005-2006
Celgene received formal approval to market Thalomid and Revlimid for certain cancers.
2006
Revlimid was introduced to the market at an initial cost of about $6,000 per month.
2017
Celgene settled a lawsuit regarding illegal marketing to avoid protracted litigation.
By 2017
Celgene raised the price of a month's supply of Revlimid to more than $16,000.

Relationships (3)

Celgene Regulated Entity / Regulator the agency
The agency issued a warning letter to Celgene in 2000 for improper marketing.
Celgene Adversarial / Competitor Association for Accessible Medicines
Celgene's actions to extend its drug monopoly are criticized by the association, which represents the generic drug industry.
Mr. Hugin Executive / Company Celgene
Mr. Hugin is described as a 'top executive' at Celgene who spoke on the company's behalf.

Key Quotes (3)

"Perhaps more than for any other available drug, the need to provide and distribute thalidomide responsibly is essential to the public health."
Source
— the agency (From a formal warning letter sent to Celgene in 2000 regarding the marketing of Thalomid.)
HOUSE_OVERSIGHT_028419.jpg
Quote #1
"Thalomid is important, because it is the financial engine that drives us."
Source
— Mr. Hugin (Statement made at an investor conference in 2004, highlighting the financial importance of the drug to Celgene before it had full approval for cancer treatments.)
HOUSE_OVERSIGHT_028419.jpg
Quote #2
"They’ve gone to pretty great lengths to protect that drug and to build as many walls around it as they can."
Source
— Michael Brzica (Describing Celgene's aggressive campaign to extend its monopoly on Revlimid and Thalomid and prevent generic competition.)
HOUSE_OVERSIGHT_028419.jpg
Quote #3

Full Extracted Text

Complete text extracted from the document (5,175 characters)

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body", "role":"body","text":"In 2000, the agency issued a formal warning letter, saying
that it had evidence the company was improperly marketing Thalomid for a variety of
cancers as well as to promote a feeling of “general well-beingâť in cancer
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the agency wrote in the
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body", "role":"body","text":"Over the next few years, however, Mr. Hugin and other top
executives repeatedly referred to Thalomid – and later Revlimid – as the key to
Celgene’s financial future, even though it would not get formal approval to market
the drugs to treat certain cancers until 2005 and 2006. In 2001, the company reported
that 92 percent of Thalomid’s prescriptions were being written to treat cancer, and
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body", "role":"body","text":"The incredible demand for Thalomid, and later Revlimid, as
promising treatments for multiple myeloma, a disease that affects more than 30,000
patients a year, was a windfall for
Celgene.","type":"text"},{"additions":[{"URL":"https://media.celgene.com/content/upload
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body", "role":"body","text":"Introduced to the market in 2006, a month’s supply of
Revlimid, a closely related derivative of thalidomide, initially cost about $6,000. By
2017, Celegene had raised the price of a month’s supply to more than
$16,000.", "type": "text"},{"identifier":" anf-heading4-
3","layout":"heading4","role":"heading4","text": "A brutal battle to fend off generic
drug makers","type":"text"},{"identifier":"anf-body-
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body", "role":"body","text":"The company was able to aggressively raise prices in part
as a result of its legal monopoly. Under federal regulations, a pharmaceutical company
can exclusively market a drug for up to seven years. Once that period expires, along
with any patents, the market opens to generic competition and prices typically fall
precipitously.","type":"text"},{"identifier":"anf-body-
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body", "role":"body","text":"“They’™™ve gone to pretty great lengths to protect that
drug and to build as many walls around it as they can,†said Michael Brzica, the vice
president for federal government affairs at the Association for Accessible Medicines,
the generic drug industry’s lobbying group.","type":"text"},{"identifier":"anf-body-
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body", "role":"body","text":"Celgene has been repeatedly accused of restricting access
to samples of its drugs, which generic companies need to test their competing
HOUSE_OVERSIGHT_028419

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