“The recent outbreak of dangerous, potentially deadly disease indicates a clear and present need for stronger accountability and oversight. Stricter scrutiny by the FDA could help prevent contamination of medicines — apparently the cause of this 23 state crisis — produced by such compounding pharmacies,” Blumenthal wrote. “Their relative immunity from standards of safety and effectiveness seems anomalous and unacceptable. The FDA's authority should be extended if necessary to make and enforce stronger standards that protect the public and assure quality.”
Compounding is a process of combining, mixing or altering ingredients in an FDA-approved drug in order to customize a medication for a particular patient, such as a lower dosage for a child. Pharmacists that compound drugs are subject to less federal regulation because it’s impractical to require safety and efficacy trials for something used by just one patient with a prescription. But the fact that the steroid injection in question was distributed to 23 states shows it was not intended for just one patient and should be subject to FDA testing and approval, according to Blumenthal.
“This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies,” the letter stated. “I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution.”
Blumenthal asked the commissioner to recommend actions Congress could take to improve the situation and prevent future problems.