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Who cares
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Sponsors
3 Co-sponsors
History
- Referred to health
Full text
The text isn't available here yet. Check nysenate.gov.
Sponsor's memo
Title of bill
An act to amend the public health law, in relation to the substitution of interchangeable biological products for prescribed products
Purpose
This bill would establish requirements for pharmacies to substitute and dispense biological products.
Summary of provisions
Section 1 adds section 279-a of the public health law to add the definition of biological product as defined in subsection (i) of section 351 of the Public Health Service Act 42 U.S.C. Section 262(i); and adds the definition of interchangeable biologic product as defined pursuant to 42 U.S.C. Section 262(k)(4) or as determined by the FDA to be therapeutically equivalent.
The bill also extends notification to the patient by the prescriber regarding the product prescribed to include an interchangeable biological product, as is existing practice with a brand name or its generic equivalent drug product and suspends the requirement that a pharmacist substitute a biologic product when an interchangeable biological substitute is not available; makes technical changes necessary to reflect the substitution of an interchangeable biological product; sets forth the conditions under which the substitution of a biologic product is required; provides for the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biologic product dispensed; requires the Department of Health to maintain a link on its web site to the current list of all biological products determined by the Federal Food and Drug Administration to be an interchangeable biological product for a specific biological product.
Section 2 provides for an immediate effective date.
Justification
Biologic products represent the cutting edge of medical science and research. They successfully treat patients with difficult to treat diseases including cancer, heart disease, arthritis, multiple sclerosis, HIV/AIDS, among others. Biologics are often used to treat patients with complex chronic disease and/or critically ill patients that have not been responsive to traditional medical treatments alone.
There are currently more than 200 FDA approved biologic therapies, including some of the most innovative new treatments for patients suffering from debilitating diseases and conditions. While New York State law governs the substitution by pharmacists of generic drugs for their branded counterparts, the existing law has not been updated to allow for the substitution of biologic products with FDA approved interchangeable biologics. This bill will update the law to reflect the growing market of biologic products and increased availability of biosimilar products that are designated as interchangeable by the FDA. Without this change to current law, automatic substitution of biologic products will be prohibited.
Prior legislative history
None
Fiscal implications
None
Effective date
Immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.