Drug Company Pleads Guilty to “End Run” Around the FDA

According to Timothy McInnis, one of the plaintiffs’ lawyers, Par Pharmaceutical “risked the lives of senior citizens across the U.S., by illegally off-label marketing [the drug, Megace ES] to the elderly.”

Today, Par pleaded guilty in federal court in Newark to “misbranding” criminal charges.  A federal magistrate judge sentenced the company to pay an $18 million fine, along with $4.5 million in forfeiture of its ill-gotten gains.  The company was also made to pledge $45 million to resolve a slew of civil cases against it.

In 2005, Par successfully won FDA approval for Megace ES.  The drug was designed to help treat AIDS patients suffering from severe weight loss.  But by then, after the drug was developed and finally brought to market, AIDS-related weight loss was no longer the crippling problem it once was.  And, faced with a declining market for its new drug, Par took a different course.

U.S. Attorney Paul Fishman called Par’s actions an “end run” around the FDA.  Refocusing its efforts, the company began marketing the drug – not to AIDS patients – but to geriatric patients, including many in New Jersey nursing homes.  This demographic can also suffer from what is known in the industry as “wasting.”

In the ensuing years, Par made $11 million of off the rebranding, never approved or assessed by the FDA.  There do not appear to be any specific allegations of harm done to geriatric patients who took Megace ES.  But, speaking at a news conference, Fishman said, “that’s not a risk that we should have to run.”

In addition to paying these large sums, the New Jersey Star-Ledger reported that Par “also signed on to a five-year integrity agreement with the federal Department of Health and Human Services that brings to bear extensive oversight of the company – with teeth.”

Hopefully, both Par and other drug companies will learn from the lessons of this case, and work with the FDA, instead of around it, to promote new pharmaceuticals.