How compounding pharmacies rallied patients to fight regulation

Published October 16, 2012

Reuters

When senators met nearly a decade ago to consider the dangers of pharmacies that mix or alter drugs with little federal oversight, health officials briefed them on some alarming findings about the safety and efficacy of drugs made by these "compounding pharmacies."
Dr. Steven Galson, a top official at the Food and Drug Administration, told the Senate Health, Education, Labor and Pensions Committee that in 2001 the agency had done a "limited" survey of drugs from 12 such pharmacies, including hormones, antibiotics, steroids and drugs to treat glaucoma, asthma and erectile dysfunction.
And he shed some light on the risks from an industry now at the heart of today's unprecedented meningitis outbreak.
Ten of the 29 drugs failed one or more quality tests, including nine that failed potency testing, some with less than 70 percent of their declared potency. By contrast, in its analyses of more than 3,000 samples from drug manufacturers, who are subject to FDA oversight, only four had quality problems.
"They had ample warning of problems in this industry," said Sarah Sellers, a pharmacist who worked in compounding before joining the FDA in 2005 to work on compliance issues surrounding compounding.
Now, as the deaths and illnesses mount from fungal meningitis linked to a contaminated steroid injection, the question of why early concerns about pharmacy compounding did not change U.S. law is a top focus for patients, regulators and lawmakers.


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