FDA Tells 3 Companies to Stop Making Unapproved Drugs
WASHINGTON — U.S. authorities said on Thursday they told three companies to stop mass-producing and distributing unapproved medicines to treat asthma, bronchitis and other breathing disorders.
The Food and Drug Administration said the companies sold thousands of doses of inhaled drugs nationwide. The companies argued they were working under a practice known as "compounding" in which pharmacists customize formulations for specific patients, the FDA said.
The FDA allows compounding if a doctor prescribes something that meets a medical need and is unavailable in an approved product. A pharmacist, for example, could crush a tablet and mix it into a liquid for someone with trouble swallowing pills, or provide a version without a preservative that could cause an allergic reaction.
The three companies – Rotech Healthcare Inc, CCS Medical and Reliant Pharmacy Services – produced large quantities of unapproved drugs that did not provide benefits over approved medicines, the FDA said.
Joe Grillo, a spokesman for Reliant’s parent Lincare Inc., said the company had no comment. Officials at Rotech and CCS Medical did not immediately return calls seeking comment.
The FDA said the products were inhaled drugs for treating asthma, emphysema, bronchitis and cystic fibrosis. Each of the conditions has FDA-approved treatments.
The medicines were distributed through mail order, Web sites and companies that sold devices used to inhale the medicines, said Steve Silverman, acting assistant director of compliance in the FDA’s Center for Drug Evaluation and Research.
Officials urged patients to talk with their doctors and pharmacists to make sure they did not unknowingly receive some of the unapproved products.
"Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk," Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.