A consumer watchdog group is calling on the U.S. Food & Drug Administration to re-inspect more than a dozen compounding pharmacies with prior violations including one in Utah.
University Pharmacy in Salt Lake City is among 16 pharmacies in 15 states issued warnings by the FDA since 2003 for safety lapses that merit revisiting in light of a recent meningitis outbreak tied to compounded drugs, says the Washington, D.C.-based group Public Citizen.
The warnings "reveal a thriving [drugmaking] industry ... being carried out under the guise of compounding," the group wrote on Thursday to FDA Commissioner Margaret Hamburg.
Public Citizen obtained and released the warnings to contradict the FDA's claim that it lacks authority to regulate specialty pharmacies like the Massachusetts-based compounder blamed for meningitis-tainted injections that have killed 36 people and sickened more than 500. The New England Compounding Center had been investigated three times by the FDA and was issued a warning in 2006, a congressional inquiry found.
Compounding pharmacies make small batches of commercially approved drugs, customized for doctors to give to patients with allergies or special medical needs.
But some have grown quite large and have taken on roles traditionally reserved for drug manufacturers, such as employing sales teams to market across state lines and operating commercial-sized equipment, said Michael Carome, deputy director of Public Citizen's Health Research Group. "If these pharmacies are going to act like drug manufacturers they need to be held to the same standards as drug manufacturers."
University Pharmacy, 1320 E. 200 South, was targeted by the FDA in 2006 for selling topical anesthetic creams used to lessen pain in cosmetic procedures.
The FDA classified the creams as new drugs because they are more concentrated than commercial products. Also, they lacked proper warnings or directions for use, argued the FDA, which ordered the pharmacy to stop making and selling them.
The order was issued in 2006, two years after an Arizona woman who used one of the pharmacy's creams died.
The FDA's delayed action and apparent failure to follow up based on a lack of any subsequent FDA records disregard its primary mission to "protect the lives of citizens," said Carome.
University Pharmacy owner Richard Rasmuson disputes that his creams were misbranded or unsafe.
"We didn't do anything wrong. We had a prescription from a doctor for a patient who misused the cream," he said.
Rasmuson developed the Photocaine gel for a local doctor to use in his laser surgical practice. The doctor touted it to colleagues from around the country who started using it with their patients.
The drug was for in-office use only, but in January 2002 a technician at a medical spa in Tucson told 25-year-old Blanco Bolanos to apply some to her legs prior to laser hair removal, according to court records.
The cream can be dangerous when applied to a large area. Bolanos lapsed into a coma and died two years later.
The family sued the doctor and pharmacy, which settled.
But Rasmuson continues to market the creams. He agreed to no longer patent them and added more explicit warnings to labels.
The state's pharmacy board fined University Pharmacy $2,000 in 2002 for employing two unlicensed technicians, according to records at the state Division of Occupational and Professional Licensing.
In 2009, the board fined the pharmacy $1,250 for filling 60 drug orders for doctors across the country without patient-specific prescriptions.
Rasmuson said FDA inspections yielded no sanctions.
He agrees with Public Citizen on one point: that the FDA already has ample regulatory authority.
He believes the 2006 crackdown was an attempt by the FDA to build a case for more authority and to squeeze compounding pharmacies out of business.
Had regulators focused on doing their job, they might have prevented the meningitis outbreak, he said. The New England pharmacy crossed a line, producing drugs at a massive scale, he said. "Compounders across the nation are up in arms about what they did," Rasmuson added.
The FDA did not respond to requests for comment.
But Carome would like the FDA's assurance that drugs produced by University Pharmacy are safe.
"Patients don't realize that some of the drugs they're prescribed have not been approved by the FDA," he said.
Compounders have filled a void left by a nationwide drug shortage. But Carome said they should be held to the same safety standards as big drugmakers.
"If they can't come up to standard, that should force them out of business," he argued, noting lives are at stake.
O Utah pharmacy implicated in woman's 2004 death. > bit.ly/QtepC6