FDA & Compounders: More Oversight Needed?

1 day ago by editor
By Ed Silverman

ver the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (readhere and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

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The Sound of Silence

LINDA GREENHOUSE October 31, 2012, 9:00 PM

Reading about the belated scramble by Massachusetts regulators toinspect the compounding pharmacies in their state in the wake of the meningitis crisis left me wondering about the apparent lack of federal oversight of the $3 billion

Markey to unveil plan sparked by deaths linked to Framingham lab

Markey to unveil plan sparked by deaths linked to Framingham lab

Mass. to Hold Hearings on State Health Department

November 1st, 2012

BOSTON (AP) — Massachusetts lawmakers are planning to announce a series of public hearings looking into the state Department of Public Health’s handling of two recent crises.

The first hearing will look at the department’s oversight of pharmacies in Massachusetts.

The hearing comes in the wake of a deadly fungal meningitis outbreak linked to a compounding pharmacy in Framingham that has sickened 377 nationwide, 29 of whom have died.

The second public hearing will look at the department’s supervision of the state drug laboratory following the testing scandal at the drug lab.

A third public hearing will look at the state’s role in overseeing the department and the need for increased transparency at the department.

State Reps. Jeffrey Sßnchez, David Linsky, and Harold Naughton plan to announce the hearing schedule Thursday at the Statehouse.

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Huge Drug Recall Latest Fallout in Meningitis Outbreak

By Sharon Begley | November 1, 2012

Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 29 people, announced on Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.

In particular, the U.S. Food and Drug Administration and a number of hospitals are concerned about the availability of several drugs for which Ameridose has been a major supplier, including those given as shots or intravenous drips or used during surgery.

The Westborough, Massachusetts-based company, which was closed on Oct. 10, said it had not received any reports of adverse reactions to the products it is recalling but that the FDA has asked it to improve its sterility testing processes.

“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health,” the company said in a statement, adding that it shipped its medications nationwide.

The company asked its customers to quarantine Ameridose drugs while they arrange to return them to the company.

Earlier in October, the FDA said, “The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”

The FDA “is aware that this recall might affect the availability of certain drugs,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Reuters. “This is a company that produces and ships a lot of sterile injectables. We are trying to mitigate the effects (of the Ameridose recall) on drug supplies.”

FILLING THE GAP

The FDA has already spoken with other manufacturers about filling the supply gap left by the shutdown of Ameridose and now the recall of its products, Woodcock said, including helping those whose manufacturing facilities have been curtailed by technical or other issues “get back into production.”

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