Howard Solomon, the CEO of Forest Laboratories (“Forest”), may be one of the most polarizing figures in the pharmaceutical industry today. Recognized as the driving force behind Forest’s success story, he is seen by many as visionary leader. In the course of seeking an appropriate medication for his mentally ill son, Howard learned of the antidepressant now known as Celexa, and he had the foresight to purchase the license to it in the United States. Because of Celexa’s popularity, Forest was catapulted from a relatively small pharmaceutical company to a powerhouse during his tenure as Chief Executive and Chairman. Howard Solomon has also functioned as a strong voice for the mentally ill and as a devoted advocate for his son.
To his critics, Solomon is seen as the man responsible for Forest’s illegal activities. With Solomon at the corporation’s helm, Forest allegedly failed to comply with the required distribution “phase-down” of its levothyroxine sodium drug product, and according to the allegations submitted inaccurate information to the FDA as part of its NDA submission for Levothroid. In addition, Forest allegedly marketed Celexa and Lexapro to pediatric patients, although they were not approved for this use. As a result, the company entered into a settlement agreement for $313 million and an onerous corporate integrity agreement. In addition to these corporate actions, Solomon is seen as a man who has profited handsomely from this behavior. According to BusinessWeek’s 2001 annual survey, Solomon was the third-highest-paid U.S. executive.
Regardless of whether you consider Solomon a role model, his potential exclusion from federal healthcare programs is peculiar and unwarranted. According to Forest’s website, Solomon was notified on April 12, 2011, of potential exclusion from federal healthcare programs in a letter from the Office of the Inspector General, Department of Health and Human Services (“HHS-OIG”). Although the company entered into a settlement and corporate integrity agreement last September, Mr. Solomon was never accused of wrongdoing in connection with these matters. This stands in stark contrast to prior exclusions, which occurred after the executive in question was personally charged and pled guilty. According to the Forest website, “the only basis given in the letter notifying Mr. Solomon of the potential action is that he is ‘associated with’ Forest.” One can only wonder why the HHS-OIG decided to make an example of an executive with such a positive image and one who was neither charged nor found guilty of a crime. Many believe HHS-OIG is trying to assert its strength, specifically its ability to wield the sword of exclusion, but its actions are likely to have the opposite effect and cause individuals to question whether it should have such power, if it’s used so indiscriminately.