WASHINGTON (Reuters) - U.S. regulators need to do more to protect asthma patients from inhaled medicines created by pharmacists from bulk ingredients, a consumer advocacy group said on Thursday.
Such drugs, known as compounds, are susceptible to contamination and doses that are too strong or not strong enough, the Consumer Health Alliance for Safe Medication said.
The coalition of patient groups and academics also said the drugs, which are liquid suspensions, have not been proven safe and rarely include proper instructions or warnings.
Large producers are the biggest concern, the group said in a petition to the Food and Drug Administration, adding that the FDA's authority to directly oversee compounds was unclear.
The group said it was most concerned about water-based compounds inhaled through breathing devices called nebulizers. Brand-name versions of such drugs include AstraZeneca Plc'a Pulmicort Respules and Sepracor Inc's Xopenex.
"You're not ... talking about local pharmacies mixing things up for special-needs patients," David Adams, the group's lawyer who helped file the request, told reporters. "What you're talking about is large-scale manufacturing that is going on under the guise of pharmacy."
Compounds are customized prescription medicines mixed from separate ingredients that can range from a pill made into a liquid to special treatments.
Such drugs were the mainstay until the mid-1900s. Now pharmaceutical companies sell most medicines in finished form for pharmacies to dispense.
LAW STRUCK DOWN
It was not clear how much of the $235 billion U.S. drug industry in 2004 came from compounded drugs. The Government Accountability Office has said anywhere from 1 percent to 10 percent of U.S. prescriptions are compounds.
FDA spokeswomen Laura Alvey said the agency had not yet received the petition but would review it carefully.
While the FDA has said compounds are technically not approved and would not meet regulatory requirements, it also has argued that they can help patients who need special treatments.
A 1997 law aimed to give the agency clear oversight and impose strict guidelines but was struck down by the Supreme Court in 2002.
Instead, the agency has said it exercises "enforcement discretion" and focuses on larger compounding companies that act more like manufacturers, relying on state pharmacy boards for other oversight.
The petition calls on the FDA to clarify its authority over compounds, then take action to ensure they are properly labeled to show they are not FDA-approved. It also asks the agency to inform the public about such drugs.
A spokeswoman for the American Pharmacists Association (APhA) said that overseeing all compounds would be unrealistic and that the FDA should instead focus on bigger firms, regulating them as manufacturers and not as compounding pharmacists.
"We support patients knowing that they are getting a compounded product," Susan Winkler said, adding that APhA did not necessarily agree with labeling that would say the drugs are unapproved.