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Drug Maker Oversight
Tue December 18, 2012
Meningitis Outbreak Shows Gaps in Regulation
Originally published on Mon December 17, 2012 1:56 pm
When the nationwide fungal meningitis outbreak exploded into headlines two months ago, Florida health officials responded quickly, tracking the contaminated drug lots and finding potential victims. At least 25 in Florida were sickened, and three died.
While the response was swift, Florida health officials concede the state failed to foresee the danger and take steps to reduce the risk. New England Compounding Center, identified as the source of the tainted drugs, had a Florida non-resident license that allowed it to send drugs into the state.
Florida relied on Massachusetts to oversee NECC's operations and make sure its drugs were safe. After the extent of its problems were exposed, NECC was shut down.
Florida law gives health officials in this state no power to regulate companies that sell drugs inside Florida but aren’t located here, Assistant Attorney General David Flynn told the Board of Pharmacy at a recent all-day hearing in Orlando.
“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box."
No permit is required
It was mere chance that the meningitis outbreak began in a different state, Board of Pharmacy members discovered. It could just as easily have started in Florida, because the state has no information on how many of the 7,897 licensed pharmacies are compounders. No permit is required.
State officials sent out a survey to all pharmacies in October, trying to learn which ones were making their own drugs, especially drugs that require a super-sterile manufacturing environment. But only 10 percent of the pharmacies filled out the survey.
So the Pharmacy Board passed an emergency rule that requires pharmacies to answer the survey or face punishment. The answers must be in by Monday.
Of all states, Florida should have foreseen trouble with compounding, after the 2009 deaths of 21 polo ponies that were scheduled to compete in a championship in Wellington. The drugs -- supposed to be vitamins -- had been made by a veterinary compounding pharmacy in Ocala.
'I couldn't answer the question'
After the NECC outbreak became big news at the beginning of October, calls started coming in to the Health Department from reporters, asking how many compounding pharmacies Florida has. Cassandra Pasley, chief of the bureau that regulates health care practitioners, saw there was a gap in the state's information.
"I couldn't answer the question as to how many compounding pharmacies we have in Florida because we really don’t have a permit called 'compounding pharmacies,'" she said.
Family doctor Kenneth Woliner says he tried to sound a warning about compounding pharmacies in early 2011 after receiving a marketing flier from Rejuvi Pharmaceuticals Inc. in Boca Raton. The flier touted the profits that doctors could make by buying drugs in bulk from Rejuvi at wholesale prices and then selling them to patients at a mark-up.
To Woliner, that didn't seem right. Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version -- if they have a doctor's prescription. They're not supposed to mass-produce other companies' patented drugs and sell them in bulk.
Specializing in hormone replacement
Rejuvi's specialty, the flier said, was hormone replacement therapy. It advertised human growth hormone and HCG, a pregnancy hormone, for anti-aging and body-building, purposes for which the drugs are not FDA-approved. While it is legal for doctors to prescribe the drugs for non-approved purposes, drug makers are not supposed to tout them for those uses.
Woliner said he thought what Rejuvi was suggesting might be illegal for the pharmacy, the doctors, or both. He felt it was certainly unethical. He filed a complaint in April 2011.
“I’ve been frustrated because I’ve seen enough of my patients who have come in from other physicians that have been exploited financially and also hurt physically because they are prescribed drugs inappropriately in excessive quantities," he said. "It's mainly because the doctor went for the mark-ups, not because the patients needed therapy.”
A month after submitting his complaint to the Health Department, Woliner got a reply. DOH said there wasn’t enough evidence to warrant action.
Complaints disappear without a trace
Woliner says this type of abuse happens all the time—and he has filed numerous complaints -- but he says the Health Department seldom does anything with them.
"It’s almost like they do not want to do the work to investigate and prosecute these cases or protect the health of the public because it’s work for them to do,” he said.
A Health Department inspector finally visited Rejuvi in early October, 18 months after Woliner filed his complaint. The inspector found a long list of problems, as Health News Florida reported. They included mouse droppings, dead insects, dirty water standing in the sink, and a covering of dust all through the compounding area.
In addition, information on patients and prescriptions was missing from the pharmacy, and drug labels were missing crucial information on the dose, lot number, and prescribing physician, the report said. Without that information it would be impossible to track down and recall the drugs if a lot were contaminated, the report said.
'Never been as horrified'
The pharmacy had been cited for problems before, the report said, but this time was worse. The inspector “has never been as horrified by the conditions of a pharmacy department as he was by the conditions of Rejuvi,” the report said.
Surgeon General John Armstrong issued an emergency suspension order on Rejuvi, shutting it down along with another compounding pharmacy.
The owner of Rejuvi declined to speak with Health News Florida; his attorney, Julie Gallagher, said of the Woliner complaint that went nowhere: “I have no comment on hearsay and speculation. If a case was closed for lack of legal sufficiency, that should tell you something. “
The Health Department can’t explain why Dr. Woliner’s complaint was so quickly shelved; in fact, officials can’t even confirm they ever got the complaint. Unless formal charges are brought, under the law the complaint remains confidential.
Gallagher says Rejuvi will appeal the suspension unless it reaches an amicable settlement.
Affordable Care Act