FDA is not empowered to directly regulate the timing for marketing of previously approved drug products, the agency says in response to citizen petitions from Mylan and Teva. The two companies wanted FDA to prohibit the marketing of authorized generics during a first ANDA filer's 180-day exclusivity period.
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The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.
