H.R. 1038 would amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products.
Detailed Summary
Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product.
Sets forth conditions for approval of such an application by the Secretary.
Allows an applicant to request that the Secretary make a determination as to the interchangeability of a comparable product and the reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Provides market exclusivity to such an interchangeable product. Requires the Secretary to defer issuing a determination of interchangeability for a subsequent comparable biological product during the period of market exclusivity for a prior interchangeable comparable biological product.
Requires the Secretary to establish requirements for the efficient review, approval, suspension, and revocation of comparable biological product applications.
Sets forth provisions governing patent infringement claims against an applicant or prospective applicant for a comparable biological product license.
Status of the Legislation
Latest Major Action: 2/15/2007: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.
Points in Favor
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Points Against
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Visitor Comments
HotRod Quarterhorses
It is irresponsible NOT to have a pathway for the review of follow-on biologics. The big drug companies who actually care about patients, like Novartis, are not scared of competition and support this bill. A pathway, without roadblocks, should be implemented asap for patients sake. And the FDA should be given the authority to decide what trials/tests are necessary. That is the FDA's job! Not Congress. Unfortunatly, this debate has exposed the truth behind some of the big pharm's - they care about profit over patients.
Mark McGuigan
Please support this bill as it will serve to start the process of reducing ever-rising drug prices and give access to more individuals for treatment.