S. 623 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 Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Points in Favor
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Points Against
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Visitor Comments
trinsic
From a quick read of this bill it looks like it forces the food and drug administration to release drugs too quickly and severely restricts due process when complaints are filed against a drug product, it also has language that is designed to lessen the impact of public comments that favor against any drug product.
Basically it makes it easier to release drugs before they are ready and limits speech against drug products. I doesn't look like it has much to do with the specifics of life saving drugs, more like its another attempt to lessen public outcry and necessary testing for health concerns.
Disease Survivor
I hope this bill passes as written. FDA should be the ones making decisions on what they need to evaluate, how long, etc. Isn't that what they do? If I can get the same drug for less money I need that help! I commend Senator Schumer for introducing this bill and I hope the big drug companies interests in profits doesn't drown out paitents needs.
Beyond the Veil
Those words sound more like they came from a pharmaceutical representative. The legislation actually hinds the FDA in verifying the safety and efficacy of the medications, gives the insurance final product prescription regardless of physician preference, and compromises an innovative company’s ability to recoup investments incurred during research and development. Schumer, Waxman, & Hatch may have sponsored the bill but it is the product of big insurance, big business, and major pharmaceutical companies. Just look for the coalition lobbying in support of the legislation.