Honorable Robert Bunda

President of the Senate

Twenty-Second State Legislature

Regular Session of 2003

State of Hawaii

Sir:

Your Committee on Health, to which was referred S.B. No. 1361 entitled:

begs leave to report as follows:

The purpose of this measure is to facilitate more timely review and adoption of drug product therapeutic equivalency information.

Testimony in support of this measure was received from the Department of Health (DOH).

This measure also clarifies prescription drug labeling to require that in the dispensing of an equivalent generic drug product, the statement "same as (brand name of the drug product prescribed or the referenced listed drug name)" or words of similar meaning be placed on the label, and to clarify which expiration date of the drug must be placed on the label.

According to the DOH, this measure is a collaborative effort involving the Drug Product Selection Board (Board) and industry members such as the Hawaii Medical Association, individual practitioners, and pharmacists. This measure would allow the Board to use the "Compendia of Therapeutically Equivalent Generic Drugs" also known as the "Orange Book", which makes for more timely approval of therapeutically equivalent generic drugs. This would result in more timely removal of nonequivalent drugs to reduce adverse patient outcomes. The Orange Book is a published document which comes online as the Compendia before it is printed.

Your Committee has amended this measure by adding a saving clause and by making technical, nonsubstantive amendments for clarity and style.

As affirmed by the record of votes of the members of your Committee on Health that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 1361, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 1361, S.D. 1, and be referred to the Committee on Commerce, Consumer Protection and Housing.