WASHINGTON -- The FDA should have closed a Texas compounding pharmacy in March shortly after inspectors found sterility problems, an action that would have prevented the recent hospitalization of 15 patients, public health advocates charged Wednesday.
In fact, Speciality Compounding in Cedar Park, Texas, is one of 50 compounding pharmacies the FDA has identified as having "significant objectionable conditions" despite only 16 such entities initiating a recall or being the subject of the agency enforcement action, consumer watchdog Public Citizen said.
"[The FDA] can prevent future injuries by exercising its authority more aggressively when it identifies problems during an inspection," the Washington-based advocacy group wrote in a letter to Health and Human Services Secretary Kathleen Sebelius. Public Citizen routinely calls for the FDA to not approve drugs it deems unsafe or to place strict warnings on others.
Speciality Compounding, about 20 miles north of Austin, Texas, announced a recall of all sterile products Friday, following reports of bacterial bloodstream infections potentially related to the company's calcium gluconate infusions.
Fifteen patients were hospitalized in Texas after receiving the calcium gluconate infusions, developing bloodstream infections caused by Rhodococcus equi. Cultures from the pharmacy's products "show growth of bacteria that are consistent with Rhodococcus species," the FDA said.
The FDA has increased its inspections and enforcement around compounding pharmacies following last fall's fungal meningitis outbreak linked to the New England Compounding Center in Framingham, Mass. That center, whose manufacturing processes were questioned by the FDA, has been linked to 63 deaths and several hundred other infections.
Other compounders, including one in Tennessee, have been linked to fungal infections this year.
Public Citizen sent the letter to Sebelius Wednesday calling for an injunction against Specialty Compounding to prevent the company from making any more sterile products.
The letter to Sebelius also called for an Inspector General investigation to determine why the FDA didn't spark a recall, issue a public safety alert, or seek an injunction after its inspection of Specialty Compounding, conducted from March 18 to 22.
A spokesman from the Texas Department of State Health Services told MedPage Today the FDA didn't provide the department with the inspection report until around Aug. 1 -- nearly 4 months after the inspection.
That inspection found employees not preventing possible contamination, committing infractions such as wearing improper clothing and picking up items off the floor with gloved hands and then not changing gloves, according to an FDA inspection report.
"The FDA knew there was a serious problem here but didn't use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected," Michael Carome, MD, director of Public Citizen's Health Research Group, said in a press release. "What's the purpose of inspecting a facility if you're not going to take appropriate action when you find conditions that pose a safety threat to patients?"
Congress is still trying to figure out how -- or whether -- to give the FDA greater power over compounding pharmacies like Speciality Compounding and the New England Compounding Center following outbreaks in the last year. The FDA has called its authority over compounders "limited, unclear, and contested" following a series of court challenges.
While the practice of pharmacies is regulated by the states, manufacturing is overseen by the FDA, so large-scale compounders are a grey area for regulators.
Senators seem willing to give the FDA authority to regulate compounding pharmacies who ship sterile products across state lines and in advance of a patient prescription. The Senate was close to voting on the bill before the full chamber 2 weeks ago but failed to do so before leaving Washington for its long August break.
Lawmakers in the House say the FDA has all the authority it needs to take action against compounders at the center of public health outbreaks. However, the unwillingness to regulate compounders has eased in recent weeks as lawmakers debate over where to draw the line between what FDA oversees and doesn't.
The FDA declined to comment Wednesday. "We are unable to comment on ongoing investigations in order to preserve the integrity of those investigations," a spokesman said.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/40998
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