Heritage Pharmaceuticals, a generic pharmaceutical company headquartered in New Jersey, was charged with conspiring with competitors to fix prices, rig bids, and allocate customers, the Department of Justice announced Monday.
According to a one-count felony charge filed on May 30 in the U.S. District Court for the Eastern District of Pennsylvania, from about April 2014 until at least December 2015, Heritage participated in a criminal antitrust conspiracy with other companies and individuals engaged in the production and sale of generic pharmaceuticals, a purpose of which was to fix prices, rig bids, and allocate customers for glyburide, a medicine used to treat diabetes. This charge is the third in the Department of Justice’s Antitrust Division’s ongoing investigation; Heritage’s former CEO and its former president were previously charged.
The Antitrust Division also announced a deferred prosecution agreement resolving the charge, under which Heritage admits that it conspired to fix prices, rig bids, and allocate customers for glyburide. Under the agreement’s terms, Heritage will pay a $225,000 criminal penalty and cooperate fully with the ongoing criminal investigation.
The U.S. will defer prosecuting Heritage for a period of three years to allow the company to comply with the agreement’s terms. The agreement will not be final until accepted by the court.
“American consumers have the right to generic drugs sold at prices set by competition, not collusion,” said Assistant Attorney General Makan Delrahim of the Department of Justice’s Antitrust Division. “It is particularly galling that, when healthcare prices in the United States are already high, certain generic pharmaceutical companies and executives engaged in collusive conduct at the expense of individuals who depend on critical medications. Heritage and its co-conspirators cheated and exploited vulnerable American patients to pad their bottom line.” Delrahim continued, “this resolution—requiring an admission of guilt, a criminal penalty, and cooperation in the ongoing investigation—sends a clear message to generic pharmaceutical companies and their executives that this conduct will not be tolerated. The Division and its law enforcement partners, including the FBI and the U.S. Postal Service Office of Inspector General, will continue to hold companies and individuals accountable for collusion that undermines the integrity of the market for drugs.”
The agreement specifically identifies the company’s “substantial and ongoing cooperation with the investigation to date, including its disclosure of information regarding criminal antitrust violations involving drugs other than those identified in the criminal charge and the agreement.” According to the agreement, this cooperation has allowed the United States to advance its investigation into criminal antitrust conspiracies among other manufacturers of generic pharmaceuticals.
Heritage also agreed to resolve all civil claims relating to federal health care programs arising from its conduct; and a conviction (including a guilty plea) would likely result in the Office of the Inspector General of the Department of Health and Human Services imposing mandatory exclusion of Heritage from all federal healthcare programs for a period of at least five years.
In a separate civil resolution, Heritage has agreed to pay $7.1 million to resolve allegations under the False Claims Act related to the price-fixing conspiracy. The government alleged that between 2012 and 2015, Heritage paid and received remuneration through arrangements on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs in violation of the Anti-Kickback Statute, and that its sale of such drugs resulted in claims submitted to or purchases by federal healthcare programs. The drugs allegedly implicated in this scheme address a wide variety of health conditions, and include hydralazine, used to treat high blood pressure, theophylline, used to treat asthma and other respiratory problems, and glyburide.