Washington State House of Representatives Office of Program Research | BILL ANALYSIS |
Health Care & Wellness Committee |
HB 2251
This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent. |
Brief Description: Concerning the expiration date for notification of dispensing an interchangeable biological product.
Sponsors: Representatives Thai and Cody.
Brief Summary of Bill |
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Hearing Date: 1/14/20
Staff: Riley O'Leary (786-7296) and Chris Blake (786-7392).
Background:
Biological Products.
A biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biological products are more complex than traditional chemical-based drugs because they are manufactured from living organisms by programming cell lines to produce desired substances. A replicated biological product will therefore not be identical to the reference product. When assessing the comparability of biological products, there are two federal Food and Drug Administration (FDA) classifications:
Biosimilars are a biological product that is compared against a reference biological product and has minor differences in clinically inactive components and there are no meaningful differences in terms of safety, purity, and potency of the product.
Interchangeable biological products are a higher standard of product than a biosimilar. These products can be expected to produce the same results in any given patient without compromising safety or efficacy.
Regulation of Substitutions.
Federal law allows a product that has been determined by the FDA to be an interchangeable biological product to be substituted for the reference product without intervention of the health care provider who prescribed the original product. State law, however, governs the substitution of drugs by pharmacists and requires that every prescription must contain an instruction on whether a therapeutically equivalent generic drug or interchangeable biological product may be substituted in its place, unless substitution is permitted under a prior-consent authorization. If interchangeability has been approved, and a cheaper alternative for the prescribed biological product is in stock, the pharmacist must substitute the interchangeable product with the original.
Notification Requirement.
Within five days of dispensing an interchangeable biological product, the dispensing pharmacist or their designee must notify the patient's practitioner and specify the biological product that has been provided to the patient. The notification must include either the name and manufacturer of the product, or the FDA's national drug code and may either take the form of a record entry in an interoperable health records system, or communication with the practitioner. This notification requirement expires August 1, 2020.
Summary of Bill:
The notification requirement for interchangeable biological products is extended from August 1, 2020, until August 1, 2025.
Appropriation: None.
Fiscal Note: Available.
Effective Date: The bill takes effect 90 days after adjournment of the session in which the bill is passed.