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Compounding pharmacy group says FDA changed inspection rules

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With legislation pending in Congress to give the Food and Drug Administration authority to better regulate compounding pharmacies such as the one linked to an outbreak that killed more than 50 people last year, the FDA went out on its own to crack down on more than 40 compounding pharmacies across the country, including one in Martinez.

The move came even as FDA Com­­missioner Margaret Ham­burg lamented that she needed authority from Congress to do what her agency was already doing.

A group representing compounding pharmacies complained that the FDA is imposing a much stricter sterility standard used for pharmaceutical makers that the pharmacies have never had to meet before, so naturally most of them are getting cited as unsterile, which “is almost akin to fear-mongering,” an industry spokesman said.

Compounding pharmacies make custom preparations, often repackaging existing drugs into different doses or creating combinations of drugs for physicians who might not be able to find the exact drug they need elsewhere.

A survey of the 23,000 members of the National Com­mun­ity Pharmacists Asso­cia­tion found almost 86 percent of them do compounding, according to testimony last week before a House subcommittee.

In the case of Clinical Specialties Compounding Pharmacy in Martinez, it was repackaging the cancer drug Avastin into smaller dose vials at the request of eye surgeons to treat patients with a form of macular degeneration.

Clinical Specialties was inspected by the FDA from March 18 through April 2 and was cited in 11 “observations,” according to a copy of the report obtained through a Freedom of Information Act request.

The most serious allegation is that those Avastin vials resulted in five cases of bacterial eye infection – four in Athens, Ga., and one in South Bend, Ind.

Clinical Specialties owner Austin Gore initially said he doesn’t have “any concerns” about the sterility of the vials and implied that the problem could have come during administration in the doctor’s office. He later referred questions to one of the pharmacy’s attorneys, Adam Moyers, who said they “remain cooperative” with the FDA.

The pharmacy recalled about six months’ worth of sterile products during the inspection process.

Clinical Specialties was one of 29 businesses apparently targeted by the FDA in the aftermath of the events involving the New England Compounding Center. That compounding pharmacy’s products have been linked to fungal bacterial infections that sickened 741 patients, including one in Georgia and three in South Carolina, and resulted in 55 deaths,
according to the Centers for Disease Control and Pre­vention.

The FDA was criticized by some for not intervening earlier when it had known about problems at the center since at least 2002.

“The agency recently took a critical look at our surveillance and enforcement approach to pharmacies that produce sterile drug products,” FDA spokesman Curtis Allen said in an e-mail. “Using a risk-based model, FDA identified 29 firms for priority inspections that focused on their sterile drug production practices.”

The agency worked with state pharmacy boards, who directly regulate compounding pharmacies, but “mobilized its Pharmaceutical Inspec­torate investigators” to do the inspections. The FDA directed The Chronicle to a site with at least 40 inspection reports on compounding pharmacies in the past few months, most with sterility concerns cited, which have resulted in a half-dozen recalls.

The problem is that the inspectors used standards for pharmaceutical manufacturers that compounding pharmacies have not had to meet before, said David Miller, the executive vice president and CEO of the International Academy of Compounding Pharmacists, which represents nearly 3,000 compounding pharmacists in the United States.

“It’s kind of like you showed up with your colleagues for your local softball team. And you’re all ready to play softball,” he said. “And the FDA team shows up wearing helmets, shoulder pads and carrying a football.”

Compounding pharmacies can’t meet those standards “so no matter what happens … I think you’re going to lose,” Miller said. “One of our big concerns is that while the agency has the ability to inspect pharmacies, it is not inspecting them consistent with how pharmacies should be inspected. They have painted this picture of compounding pharmacies as not meeting sterile standards, having to issue recalls, when in reality the yardstick by which they measured those pharmacies was totally inappropriate and incorrect.”

While the inspection reports for the drug makers almost never see the light of day, the pharmacy reports have, Miller said.

“The interesting thing is the agency appears to be using selectively identified problems at compounding pharmacies in a way that is almost akin to fear-mongering,” he said.

Legislation is pending in the U.S. Senate that would clarify the FDA’s ability to regulate compounding pharmacies and give the agency the ability to inspect them on a “risk-based schedule.” Hamburg wrote in a blog that there was need for legislation because “our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry.”

But the FDA has already asserted that authority, Miller said.

In the meantime, those who have been inspected are in various states of operation, with some completely shutting down their sterile drug business, and there is likely to be at least one lawsuit over it but nothing has been filed yet, Miller said.

As for Clinical Pharma­cies, Moyers would only say, “The pharmacy was never closed.”


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