FDA seeks input from states on drug compounders

Dec 21 2012

FDA Commissioner Margaret Hamburg convened a meeting that included federal officials and representatives from state boards of pharmacy and governors' offices. Meanwhile, the Los Angeles Times reports on "rogue pharmacists."

The New York Times: F.D.A. And States Discuss Regulation Of Drug Compounders
The Food and Drug Administration conferred with public health officials from 50 states on Wednesday about how best to strengthen rules governing compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted pain medication produced by a Massachusetts pharmacy. It was the first public discussion of what should be done about the practice of compounding, or tailor-making medicine for individual patients, since the F.D.A. commissioner, Dr. Margaret Hamburg, testified in Congress last month about the need for greater federal oversight of large compounding pharmacies. So far, 620 people in 19 states have been sickened in the outbreak, and 39 of them have died (Tavernise, 12/19).

The Wall Street Journal: FDA Lagged On Specialized Pharmacy Regulations
The Food and Drug Administration under President Barack Obama didn't push for a law to regulate drug-mixing pharmacies before a recent outbreak of more than 600 meningitis cases tied to such a pharmacy, the head of the agency said Wednesday. FDA Commissioner Margaret A. Hamburg said her agency didn't press for such a law despite numerous deaths and illnesses over several years linked to compounding pharmacies. She made the remark at a summit meeting the FDA held Wednesday with officials of all 50 states who regulate compounding pharmacies (Burton, 12/19).

CQ HealthBeat: State And Federal Officials Explore Details Of Additional Regulations On Compounding Pharmacies
Some state officials seemed open to more uniform definitions and standards for overseeing compounding pharmacies, at a meeting Wednesday between officials from all 50 states and the Food and Drug Administration. However, FDA Commissioner Margaret Hamburg called the daylong meeting the beginning of a long conversation among state boards of pharmacy, governors' staffs and federal officials. The focus on compounding pharmacies emerged after a company, the New England Compounding Center in Massachusetts, released contaminated products that sparked a widespread national outbreak of deadly fungal meningitis that resulted in 620 illnesses and 39 deaths as of Dec. 17 (Adams, 12/19).

Medpage Today: Compounding Pharmacies Focus Of All Day Hearing
The FDA and health officials from all 50 states came together Wednesday for a one-day workshop to help identify and close the gaps in overseeing compounding pharmacies including the ones like the Massachusetts one linked to 39 deaths from fungal meningitis. Heads of state boards of pharmacy -- who oversee compounding pharmacies -- told the FDA they need better communication with the federal agency and greater clarity in certain areas to understand what aspects they're responsible for and what the FDA controls. In the nearly 3 months since the outbreak started, the FDA has claimed gaps in regulating compounding pharmacies helped facilitate lax oversight of Framingham, Mass.-based New England Compound Pharmacy (NECC), found to have shipped tainted steroids that later infected more than 600 patients in 19 states (Pittman, 12/19).

Meanwhile, the impact of the meningitis outbreak continues to reverberate -

Reuters: U.S. Fungal Meningitis Outbreak Could Have Been Much Worse: CDC
As bad as the 2012 fungal meningitis outbreak has been, so far infecting 620 people in 19 states and killing 39 of them, it could have been a lot worse, U.S. health officials said on Wednesday. Prior and much smaller fungal outbreaks involving tainted spinal injections were far more deadly, killing as many as 40 to 50 percent of those who had become infected, said Dr. Rachel Smith, an epidemic intelligence service officer at the Centers for Disease Control and Prevention (Steenhuysen, 12/19).

Also, the Los Angeles Times continues its look at misuse of prescriptions.

Los Angeles Times: Rogue Pharmacists Fuel Addiction
Pharmacists are supposed to be a last line of defense against misuse of prescription medications. By law, they are required to scrutinize prescriptions, size up customers and refuse to dispense a drug when they suspect the patient has no medical need for it. Some, however, provide massive amounts of painkillers and anti-anxiety drugs to addicts and dealers with no questions asked, according to state records, regulators and law enforcement officials. Rogue pharmacists are key enablers of drug abuse and an important source of supply for the illegal market (Glover, Girion and Branson-Potts, 12/20).