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When the federal government started issuing press releases about an Arkansas drug company, it was about as lethal as the lawsuit that followed.
The Federal Drug Administration alerted health care professionals and patients not to use drugs from Cantrell Drug Company. Adding injury to insult, the U.S. Department of Justice also issued a press release when it sued the company for allegedly distributing adulterated drugs.
Dr. James McCarley, Jr., founder and chief executive of the company, responded by issuing his own press release and filing his own suit against the government.
From 1952 Until?
Cantrell has been in business since 1952, providing injectable pharmaceuticals that are used primarily in hospitals. But that may be about to end because the federal government is trying to put the company out of business.
"My back is really against the wall," McCaley said. "The FDA has inspected us twice in the last year and voiced concerns about quality deficiencies that are strictly regulatory in nature and not in response to any product problem or patient illness."
The doctor is asking a bankruptcy court to stop the FDA from shutting him down. Meanwhile, the government is seeking a temporary restraining order to do just that.
"The Department of Justice is committed to ensuring that patients receiving compounded drugs are protected by the safeguards established in federal law," said Acting Assistant Attorney General Chad A. Readler.
In its lawsuit, the justice department says FDA inspected the drug company and found "evidence of insanitary conditions and significant deviations" from good practice regulations. The complaint says it found clean-room areas with microbes of bacteria in excess of their "action limit."
According to the government, certain bacteria could cause "serious adverse effects" to patients. The FDA also found "spore-forming bacteria" in areas used for drug compounding and on operator gloves.
The proposed injunction would require Cantrell to cease operations and to recall and destroy all non-expired drugs manufactured or distributed by the company.
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