Makena Pricing Prompts Multi-Pronged Appeals: FDA, FTC – Bayh-Dole?
The uproar among insurers, physicians and patient groups over the relatively high price of KV Pharmaceutical’s new injectable treatment for preventing preterm births, Makena, has elicited appeals to FDA and the Federal Trade Commission for intervention.
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The controversies have shown that, while it may be easy to scapegoat outliers, it is remarkably hard to lower a drug price by political fiat. It took a while, but now Makena, Daraprim and Acthar are all facing very different days of reckoning.
West-Ward could be the first to gain approval for phenylephrine in hypotension, but the drug’s widespread use as a stand-by medication during surgery could deter FDA enforcement against unapproved versions.
During a hearing in the company’s lawsuit against FDA, a federal judge repeatedly questions her authority to require the agency take enforcement action against compounding pharmacies; KV filed for bankruptcy protection three days earlier, citing its inability to realize full value of the pre-term birth drug due to competition from cheaper compounded versions of 17-P.