Congress’ year-end coronavirus relief and spending deal appears to include FDA-related provisions that would extend the agency’s rare disease priority review voucher program until 2024, allow biosimilars applicants to reference previously approved indications in their applications, give FDA authority to require that generic drug labels be updated, and clarify that orphan drugs and biologics must prove clinical superiority.
The provisions are included in an unconfirmed text of the bill that was floating among lobbyists late Sunday evening (Dec. 20).
The bill aims to extend the rare disease priority review voucher program until 2024.
The program, which allows companies that produce a drug or biologic approved to treat a rare pediatric disease to receive a voucher for priority review of a subsequent drug product, expired in September, but the program was extended until December under a continuing resolution.
Under the year-end deal, the PRV program would be extended through Sept. 30, 2024.
Congress also included two FDA provisions that the Senate health committee had previously tucked into drug pricing legislation.
One provision clarifies that biosimilars applicants can include information in their applications showing that proposed indications for a biosimilar were previously approved for the reference product.
Earlier this year, FDA published a draft guidance that recommends biosimilar makers, when possible, seek licensure for all of the reference product’s licensed conditions of use. However, the agency also makes clear that applicants are allowed to seek licensure for fewer than all of the reference product’s indications.
Also tucked into the year-end package is a provision, the Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act, that gives FDA authority to require that outdated labeling of certain generic drugs be updated to ensure accurate information is relayed to consumers. The provision requires FDA to report any labeling updates.
In November, the House passed its version of MODERN (H.R. 5668), which is sponsored by Rep. Doris Matsui (D-CA) and House Energy & Commerce oversight subcommittee ranking Republican Brett Guthrie (KY), but the bill didn’t move through the Senate.
Another provision in the year-end bill requires that sponsors seeking orphan drug designation and exclusivity for a drug or biologic demonstrate their product is clinically superior to an already-approved similar drug.
Sources said they had expected the bill to contain language about requiring certain biological product patent information to be submitted to FDA and published in the Purple Book. However, that language was not included in the text of the bills obtained by IHP. — Beth Wang (firstname.lastname@example.org)