Guilty Plea Likely For Local Drug ExecAug 10, 2004 | www.charlotte.com
The former manager of a Charlotte pharmaceutical plant is to plead guilty this week to a federal felony charge that she and others conspired to put the wrong expiration date on the packaging for millions of generic thyroid pills, federal prosecutors said Monday.
Frances Hutchins, who still works at Vintage Pharmaceuticals Inc., has agreed to plead guilty Wednesday before a U.S. magistrate judge. She also pledged to cooperate with the government's ongoing investigation, prosecutors said.
Hutchins was manager of the Vintage plant, at 3241 Woodpark Blvd. in northeast Charlotte. The company makes generic versions of medications, including Levothyroxine Sodium USP, a treatment for hypothyroidism.
U.S. prosecutors say that from January 1999 to January 2001, Vintage officials sold about 57 million Levothyroxine tablets labeled with expiration dates of 12 months from the time of production.
But that labeling was an intentional error, because Vintage officials knew the pills lost their potency before 12 months, the government alleges.
Late last month, a federal grand jury in Charlotte issued an indictment against company officials alleging conspiracy, wire fraud and the introduction of misbranded and adulterated drugs into interstate commerce.
The company responded with a brief prepared statement that said, in part; "The allegations made today by the government are totally without merit."
A company spokesman declined further comment. Neither Hutchins nor her attorney could be reached for comment Monday.
Vintage, a private company, has production plants in Charlotte and Huntsville, Ala. It employs 120 people at the Charlotte plant.
Vintage's products are distributed to retail pharmacies through a sister company, Qualitest Products Inc. of Huntsville.
Vintage's problems with the government date to at least 1997, according to a narrative included in the indictment.
In 1997, U.S. Food and Drug Administration inspectors found problems at Vintage's Charlotte and Huntsville plants. The FDA said the company wasn't taking proper steps to make sure its products were safe, effective and potent for as long as product packaging indicated.
In July 1998, the government sought a court order to shut down manufacturing in Charlotte and Huntsville. The suit was settled four months later, when the company agreed to several steps, including hiring independent experts to audit and help improve plant operations.
But in October 2000, a former employee at the Charlotte plant told the FDA that problems persisted. The whistleblower said Vintage was using 12-month expiration labels on the thyroid drug, even though internal analyses showed the tablets didn't retain their strength that long.
That led to the criminal investigation and the recent indictment against the company and two individuals: William Propst Sr., president of Vintage; and William Propst Jr., assistant to the president.
In a separate but related case, U.S. Attorney Gretchen Shappert charged Hutchins with conspiracy to defraud the government and sell adulterated and misbranded drugs from state to state.
Hutchins still works for Vintage, a company spokesman said. He declined to specify her current position.
Hutchins and the Propsts are not going to comment about the legal actions, he said.
Criminal prosecutions of pharmaceutical companies are relatively unusual. In 2002, the U.S. government prosecuted only about a half-dozen drug makers.
"It is not a routine action," said Mary Lewis, spokeswoman for the FDA office in Raleigh.