Actually lack of regulations and enforcement is killing people.
This editorial from yesterday's New York Times sums it up:
The more that reporters and regulators dig into the cause of the meningitis outbreak that has sickened more than 300 people in 18 states and killed 24, the worse it all looks. The Massachusetts pharmacy that produced the contaminated injectable steroid linked to the outbreak has a long, troubled history. But the issues of shoddy manufacturing practices and lax regulation go well beyond one company.
The New England Compounding Center in Framingham, Mass., has a record of violating state law by selling compounds in bulk without prescriptions for individual patients. It has also failed to follow standard procedures to keep its facility clean and its products sterile. In fact, it appears to have shipped the injectable steroid to some customers without even waiting for final sterility test results.
State regulators, who have primary responsibility for policing compounding pharmacies, did too little monitoring before this outbreak. A state inspection at the pharmacy last year found virtually no problems. Yet an inspection after the outbreak found dirty mats and hoods, and even debris floating in vials of medicine.
Manufacturing problems appear to affect many compounding pharmacies, whose products are not routinely tested by safety and effectiveness, as are the drugs made by major manufacturers. State regulatory tests in Missouri and Texas found that up to 25 percent of randomly sampled compounded drugs failed potency tests. And tests by the Food and Drug Administration on a limited number of drug samples from compounding pharmacies found that roughly a third of the products failed quality tests.
Gov. Deval Patrick has belatedly announced a new approach — periodic, unannounced inspections of compounding pharmacies and requiring annual reports on the volume and distribution of their products. Other states would be wise to look at their own laws and practices to see if they need tightening.
Meanwhile, Congress needs to grant the F.D.A. whatever additional powers it deems necessary to inspect the pharmacies, monitor their sales and judge the safety or effectiveness of their products. The problems need to be addressed on a nationwide basis, not just through states, which often have limited resources and expertise.
Buerkle would rather rely on the "magic of the marketplace."
But in your position you have the public trust to protect, Annie. Did you skip that class?
No comments:
Post a Comment