The FDA has been threatening to move against pharma executives whose companies stray outside the law. Perhaps out of frustration with repeated off-label marketing violations, agency officials have publicly promised that some people would be held personally accountable. Who would be first?
Apparently that dubious honor falls to Forest Laboratories chief Howard Solomon. The Department of Health and Human Services Inspector General has notified Solomon that he may be barred from the pharma industry completely. Solomon gets 30 days to respond to the IG, and if that doesn't convince the agency, then he'll have to persuade a judge that he shouldn't be excluded. If that fails, then he'll be forced to resign.
Forest quickly announced Solomon's intent to fight back. "Mr. Solomon plans to commence immediate litigation to prevent such exclusion from taking effect," the company said, calling the HHS move "unwarranted and unprecedented." The inspector general's letter doesn't accuse Solomon of wrongdoing, but bases its potential ban on the fact that he is "associated with" Forest, the company says. In fact, Forest board member William Candee said in a statement, "At no time during the government's six-year investigation of Forest was Mr. Solomon ever accused of any wrongdoing in connection with the matters settled in 2010."
Those "matters" would be the company's $313 million settlement with the Justice Department to resolve accusations that it marketed three drugs for off-label uses, distributed a drug that wasn't FDA-approved, and obstructed the government's investigations. Criminal penalties amounted to $164 million of that agreement.
In Forest's statement, its general counsel rightly points out that other drugmakers have agreed to pay larger criminal and civil penalties, but those companies' executives haven't faced personal consequences. "[O]ther major pharmaceutical companies have pled guilty to much more egregious offenses," Herschel Weinstein said, "and none of them has faced the exclusion of a senior executive who has not himself been convicted of a crime or pleaded guilty to a crime." Is Solomon's case a test of the agency's legal ability to pursue individual managers?
- see the Forest release
- get the news from Reuters
- read Pharmalot's take
Special Report: Big Pharma behaving badly: A timeline of settlements.