House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

Regulatory NewsRegulatory News | 16 July 2020 |  By 

The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.
(RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more, Regulatory Focus 29 January 2020).
“These bills will expand coverage and access to care, strengthen mental health parity, provide mental health support to first responders, enhance transparency and operability of the Strategic National Stockpile and improve the safety of America’s food, drugs and medical devices,” said Committee Chairman Frank Pallone (D-NJ).
One of the bills, H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, would require drugmakers seeking orphan exclusivity for a product because it would not be profitable to demonstrate that there is no reasonable expectation that they will recoup the cost of developing the drug within 12 years of marketing in order to obtain or retain orphan drug exclusivity.
Another bill, H.R. 5663, the Safeguarding Therapeutics Act, would give FDA the authority to destroy imported adulterated, misbranded or unapproved medical devices that it deems to be a threat to public health. The new authority would build on the agency’s authority to destroy adulterated, misbranded or counterfeit drugs under the Food and Drug Administration Safety and Innovation Act.
FDA would gain another new authority under H.R. 5668, the Making Objective Drug Evidence Revisions for New Labeling Act of 2020, to require drugmakers to update the labeling of older generic drugs when new scientific evidence is available regarding the drugs’ use, to reflect accepted uses of the drug in clinical practice that are not currently reflected in the approved labeling and when the labeling does not meet current legal and regulatory requirements.
Additionally, H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, would direct FDA to designate national centers of excellence in continuous pharmaceutical manufacturing that would work with the agency and industry “to craft a national framework for continuous manufacturing implementation.” The bill would provide $80 million in appropriations for designated centers of excellence each year from FY2021-2025.


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