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The FDA, meanwhile, took the unusual step of deciding not to prevent compounders from compounding.
FORBES: KV Pharma Finally Wins A Victory, For Now
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As a result, the FDA has shifted resources this year and inspected dozens of compounders, issuing numerous inspection reports along the way.
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Rather embarrassingly, the pills from the compounders (meaning prescription D) were almost as variable as the OTC pills, varying from 23% to146% of the expected dose.
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In other words, the compounders are living in limbo.
FORBES: The Meningitis Outbreak: What Can Compounding Pharmacies Do Next?
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Beyond that, a good argument can certainly be made that the compounders are well-advised to welcome federal oversight and the confidence in its products that the FDA stamp of approval would engender.
FORBES: The Meningitis Outbreak: What Can Compounding Pharmacies Do Next?
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The recent congressional hearings held by House and Senate committees are being interpreted as a good indication that bi-partisan support can be mustered to pass legislation that would strengthen FDA oversight of compounders.
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The FDA, you may recall, has recently made a concerted effort to inspect compounders in the wake of the fungal meningitis outbreak that was linked to a pharmacy called the New England Compounding Center.
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But the decision not to pursue enforcement actions against compounders, unless there was a safety issue, signaled White House concern about publicity over cost, since a federal agency had effectively allowed a monopoly to develop.
FORBES: KV Pharma Finally Wins A Victory, For Now
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At the same time, KV Pharma filed a lawsuit against the FDA for failing to take action against compounders ( find it here), and also sued Georgia and South Carolina for restricting Makena coverage ( link to lawsuits are here).
FORBES: KV Pharma Finally Wins A Victory, For Now