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Conditional marketing authorisation: easier to grant than to revoke

Progesterone is ineffective at preventing preterm delivery, but proved difficult to withdraw from the market. It is not the only example of this phenomenon.
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Many marketing authorisations are granted despite inadequate evaluation, with certain conditions attached, such as a requirement to conduct clinical trials after the product's market introduction: they are conditional marketing authorisations.

Intramuscular hydroxyprogesterone (Makena°) was authorised by the US Food and Drug Administration (FDA) in 2011 on condition that the company produced results showing efficacy in reducing neonatal morbidity and mortality from complications of preterm birth. The trial, conducted for this purpose and completed in 2018, did not demonstrate the product's efficacy in improving these outcomes.

In 2019, an FDA advisory committee concluded that the conditions attached to this marketing authorisation had not been met, but the pharmaceutical company requested a hearing to contest its withdrawal.

In September 2022, the FDA's internal evaluators again recommended revoking the marketing authorisation for Makena°, due to lack of efficacy and its adverse effects for the mother (in particular deep vein thrombosis). In April 2023, the FDA's Commissioner and Chief Scientist finally decided to withdraw approval for Makena°.

©Prescrire 1 September 2023

Source: "Conditional marketing authorisation: easier to grant than to revoke" Prescrire International 2023; 32 (251): 223. Free.

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