BioCentury
ARTICLE | Politics & Policy

May 8 P&P Quick Takes: FTC, Part D, Orange/Purple Book, FDA, Cornyn/Blumenthal

May 8, 2019 11:06 PM UTC

FTC objects to FDA's latest guidance on biologic naming
The Federal Trade Commission again advised that FDA drop its biologic suffix naming convention because it could diminish biosimilar competition, bolstering arguments from some biosimilars manufacturers that have asked FDA to reconsider its policy. FDA's latest guidance would not affect legacy biologics, which FTC said would create two groups of biologics -- those with a suffix and those without -- and "likely would create consumer confusion and discourage use of newly introduced biosimilar and interchangeable products" (see "FTC Challenges FDA's Biosimilar Naming Proposal").

HHS-Labor committee faults CMS's attack on Part D protected drug classes
In a report, the House appropriations committee raised a concern that CMS's proposed Part D rule change to allow increased use of prior authorizations and step therapy requirements for drugs in protected classes such as HIV and cancer treatments could delay access to those drugs (see "CMS Takes Aim at Protected Drug Classes, Allowing Step Therapy, Exclusions")...