US FDA’s Narrow Path For Imports: Beware The 'SIP'-pery Slope
Newly proposed pathway to allow states to pursue wholesale importation of drugs from Canada is extremely narrow and restrictive, at least in draft form. It is still a terrible precedent for industry – one that can be easily expanded if it takes effect.
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Proposed rule allowing states to import certain drugs from Canada would require tight supply chain, extensive security and reporting responsibilities. The potential costs and rigor involved in implementing the program could impede its uptake.
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.
Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.