Designates the subtitle the ‘‘Biologics Price Competition and Innovation Act of 2009” for citation purposes and expresses the sense of the Senate that a biosimilars pathway “balancing innovation and consumer interests” should be established.
Browse the sections of Title VII
Authorizes a process through which to license products that are biosimilar to, or interchangeable with, a reference product. Provides a 12-year exclusivity period for the reference product. Additionally creates a one-year exclusivity period, generally, for the first biosimilar product to be determined as interchangeable for a given reference product before other such determinations can be made. Amends the Federal Food, Drug...
Requires that any savings resulting from this subtitle, determined by HHS and Treasury each fiscal year, be applied to deficit reduction.
Amended by section 2302 of HCERA. Effective January 1, 2010, broadens eligibility for participation in the 340B drug discount program to certain children’s hospitals and free-standing cancer hospitals; critical access hospitals; and rural referral centers or sole community hospitals meeting certain criteria. Excludes orphan drugs from 340B discounts for newly qualifying entities.
Creates new reporting, auditing, oversight and other compliance procedures for HHS relevant to both manufacturers and 340B covered entities, including civil monetary penalties against manufacturers as well as sanctions for covered entities. Directs HHS to implement an administrative dispute resolution process for covered entity as well as manufacturer claims.
Requires the GAO report to Congress within 18 months on whether individuals served by 340B covered entities are receiving “optimal healthcare services,” including providing recommendations on whether the program should be expanded, whether mandatory sales of certain products by the 340B program could hinder patients’ access to those therapies through any provider, and whether income from the 340B program is...