On September 1, 2020, Carolyn B. Maloney, Chairwoman of the United States House of Representatives Committee on Oversight and Reform sent a memorandum to the Committee, alerting them to her intent to issue a subpoena to AbbVie Inc. seeking documents on its treatments Humira and Imbruvica as part of its investigation into drug pricing.
Background
This issue dates back to January 2019, when former Committee Chairman Elijah Cummings announced that the Committee would be conducting the investigation. At that time, Cummings wrote a letter to AbbVie CEO Richard Gonzalez, requesting information on price increases, investments in research and development, and corporate strategies to preserve market share and pricing power for its medications.
Six months later, on June 21, 2019, Chairman Cummings sent a follow-up letter to AbbVie (and others who had not yet responded to his January request). Then, three months later, on September 27, 2019, he sent a third letter (this one only to AbbVie) warning that the responses were “woefully inadequate” and that if complete responses were not provided, the Committee would be forced to consider a subpoena to obtain proper responses.
“After more than 18 months, AbbVie has demonstrated its unwillingness to comply voluntarily with the Committee’s investigation,” Maloney wrote in the memo. “The volume and quality of AbbVie’s responses are inconsistent with the expected recordkeeping and decision-making processes of a large multi-national corporation regarding two of its most profitable drugs. In addition, the volume and quality of AbbVie’s responses are particularly poor in comparison to the documents produced by other companies that are the subject of the Committee’s investigation—particularly given that the Committee is examining two of AbbVie’s most profitable products.”
The Subpoena
The subpoena requests documents ranging from January 1, 2009 to January 14, 2019 (when the investigation was launched). Some of the documents requested include all documents – including communications – referring or relating to pricing or lifecycle management strategies, including the following topics:
- Whether to increase Humira’s list price;
- Increasing Humira’s price either in response to, or anticipation of, changes in price of its competitors;
- The impact a Humira price change would have on the company’s earnings, revenues, and earnings per share;
- Strategies to respond to the potential loss of exclusivity for either Humira or Imbruvica or to lengthen either exclusivity period; and
- Communications involving Richard Gonzalez regarding the price of either drug, strategies to increase the period of market exclusivity, and any risks posed by potential loss of exclusivity.
The subpoena also requests all documents, including communications, referring or relating to the potential impact on the sales, revenue, or market share of Imbruvica through the introduction of a single dosage or single tablet regimen.
All documents, including communications, referring or relating to the company’s expenditures on drug donation or co-pay assistance programs, or any other manufacturer-affiliated or independent patient assistance or prescription assistance programs for Humira, including any analyses on the return on investment of such programs, is also requested by the subpoena.
Documents were also requested to show AbbVie’s exact method of calculation of bonuses for the ten highest-paid employees of AbbVie Inc, between January 1, 2014, and January 14, 2019.
The subpoena finally requests documents showing the following from 2009 to 2019:
- Cost of Goods Sold for Humira and Imbruvica;
- The average net price for Humira and Imbruvica;
- Highest, lowest, and average net price for Humira and Imbruvica, by channel;
- Highest, lowest, and average rebate per unit for Humira and Imbruvica, by channel; and
- AbbVie or Abbott Laboratories’ yearly research and development costs related to Humira and Imbruvica.
This subpoena is the latest move in the probe that began last year under former Committee Chairman Cummings and that has so far sought information from twelve different drugmakers on price increases, strategies to preserve market share, and pricing power.