The U.S. House of Representatives recently passed a series of bills, including two important FDA-related legislation: the Generic Labeling Act and the Orphan Drug Franchise Act.
under the Objective Drug Evidence Amendment Act (MODERN Labeling Act) (H.R. 5668), the FDA can force changes to generic labels even if the reference product has been withdrawn from the market, leaving the label in a "frozen" state.
the FDA for many years.
has been trying to resolve the issue through the development of administrative regulations, but with little success, please refer to the "Label Proposed" collection of forest information on the history of the proposed labelling requirements.
the FDA's previous labeling proposals, the new law requires far more FDA requirements (constraints) than corporate requirements, and more work needs to be done by the FDA.
Under the Orphan Drug Franchise Fairness Act (H.R. 4712), the FDA can revoke or deny the product orphan drug franchise if the bidder cannot prove that the sale does not cover the full cost of development.
cost-recovery provisions in the Orphan Drugs Act have only been used a few times, but Congress only paid attention when Indivior claimed a seven-year franchise with sublocade in 2017 using the orphan drug pathway.
sublocade was identified as an orphan drug in 1994, but by the time it was approved, the opioid crisis was raging and cost recovery was highly likely.
the FDA ultimately refused to grant the franchise, but House members wanted to address the rule and ensure that generics were not delayed.
House of Representatives passed both bills by oral vote on 17 November and submitted them to the Senate for consideration.
addition, a pharmaceutical-related bill passed the House of Representatives in September and is awaiting Senate consideration , the 2019 National Center of Excellence for Continuous Drug Manufacturing (H.R. 4866). The
Act authorizes the FDA to identify the National Center of Excellence for Continuous Manufacturing (NCE), which will work with the FDA and industry to develop a national framework for continuous manufacturing implementation, including additional research and development to support this technology, workforce development, standardization, and working with pharmaceutical manufacturers to support the adoption of continuous manufacturing.
Act authorizes an annual grant of $80 million to NCE from FY2021 to FY2025.