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FDA chief renews push for specialty pharmacy rules

Published on NewsOK Modified: December 19, 2012 at 4:54 pm •  Published: December 19, 2012

While the FDA's proposal has idled in Congress it has also attracted criticism from consumer safety advocates — who typically favor more regulation.

The health safety group Public Citizen argued that the FDA already has the authority to shut down operations like the NECC, since the pharmacy had clearly crossed the line from mixing prescriptions to manufacturing drugs. In a letter released Tuesday, the group said that the new laws sought by the FDA would actually do more harm by legitimizing the activities of rogue pharmacies like the NECC.

"This proposal, if implemented, would validate the FDA's current lax enforcement practices for drug manufacturing conducted under the guise of pharmacy compounding," the group states in a letter to Health and Human Services Secretary Kathleen Sebelius.

Also on Wednesday, health officials released new details about the outbreak investigation.

In an article published by the New England Journal of Medicine, officials discussed how illnesses were tied to three lots of the steroid — methylprednisolone acetate — made at New England Compounding. The first lot was made in May and included about 6,500 vials. A second, of nearly 6,300 was, produced in June. The third, of 4,900 vials, was made in August.

Well over half of the cases of meningitis and other fungal infections were tied to the June lot, investigators said in the article.

The same finding applied to deaths, according to additional information released this week by the Centers for Disease Control and Prevention. Nearly two-thirds of the deaths were in people who received shots from the June lot.

It's not clear why deaths and illnesses were so much more common in patients who got the June doses, said Dr. Benjamin Park, head of the CDC team that investigates fungal diseases.

The CDC said the first death from the outbreak occurred in Florida in July. The 38 other known deaths occurred in September or afterward, including two this month.

Things could have been much worse. In some earlier fungal meningitis outbreaks, as many as 40 percent of the people who grew sick ultimately died. In this outbreak, 6 percent died.

CDC officials believe some lives were probably saved because health officials and health workers teamed up to quickly contact nearly everyone who got a shot from the tainted lots, and start treating those with worrisome symptoms.

Now it's been three months since the outbreak was first recognized, and new meningitis cases have become increasingly rare. But it's possible some cases may still develop. Meanwhile, health officials continue to discover a steady number of new cases of other types of fungal infections, including potentially dangerous pus pockets forming at the spine of some of the steroid patients.

Health officials believe there are more patients who need to undergo MRI scans to detect infections.

"It's not over yet," Park said.


AP Medical Writer Mike Stobbe contributed to this story from Atlanta