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Makena’s Reimbursement Coverage Remained Unchanged After Confirmatory Trial Failure

 
• By Cathy Kelly

As milestone approaches in FDA effort to pull the pre-term birth drug, the findings suggest that by leaving Makena on the market, the agency may be ‘furthering plan inaction,’ Tufts Medical Center researchers conclude.

Ongoing Coverage May Reflect Lack Of Alternative Treatments • Source: Shutterstock

Private health plans continued to cover Covis Pharma’s preterm birth prevention drug Makena without restrictions even after the drug failed in the confirmatory trial finally completed nine years after the drug’s controversial accelerated approval, according to an analysis published in Health Affairs on 13 January.

The apparent lack of any effort to curtail access to a drug that has not been shown to be effective...

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• By Dean Rudge

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.