SENATE HEALTH, EDUCATION AND SOCIAL SERVICES COMMITTEE March 8, 2000 2:40 p.m. MEMBERS PRESENT Senator Mike Miller, Chairman Senator Pete Kelly, Vice-Chairman Senator Gary Wilken Senator Kim Elton MEMBERS ABSENT Senator Drue Pearce COMMITTEE CALENDAR SENATE BILL NO. 261 "An Act relating to needle stick and sharps injury protections and the use of safe needles by health care facilities and health care professionals; and providing for an effective date." -HEARD AND HELD PREVIOUS SENATE COMMITTEE ACTION SB 261 - No previous Senate action. WITNESS REGISTER Senator Kim Elton Alaska State Capitol Juneau, Alaska 99801-1182 POSITION STATEMENT: Sponsor of SB 261   Mr. Jacob Mater II, Director Government Affairs Aventis Pharmaceuticals 169 John Henry Circle Folsom, CA 95630 POSITION STATEMENT: Supports SB 261 but asked that the bill be  amended.    ACTION NARRATIVE TAPE 00-10, SIDE A Number 001 CHAIRMAN MILLER called the Senate Health, Education and Social Services (HESS) Committee work session to order at 2:40 p.m. Present were Senators Wilken, Elton, and Chairman Miller. SB 261-PROTECTION FROM NEEDLE & SHARPS INJURIES  CHAIRMAN MILLER announced that today's meeting was postponed due to a lengthy Senate floor session and he apologized for the inconvenience. He noted his intention to hear the sponsor's statement today and to take testimony from a person who traveled from out-of-state to testify. He announced that the bill will be heard again on March 21 and asked anyone else wishing to testify on the bill to participate in that meeting. SENATOR KIM ELTON, District B, gave the following abbreviated sponsor statement. SB 261 provides for a safer needle and sharps instrument regime in health care facilities. Similar legislation has been addressed by five states and has been introduced in 20 other states. He worked closely with health care providers to try to develop a workable law. He indicated a proposed amendment, which he will ask members to support at the next meeting, that allows some leeway for pre-filled needle manufacturers to ensure that SB 261 works for them also. MR. JAKE MATER, Government Affairs Director for Aventis Pharmaceuticals, said he was speaking for Aventis and other manufacturers who have sent written letters to committee members. Manufacturers of pre-filled syringes are concerned that under the current laws in other states, pre-filled syringes are not currently engineered with sharps devices. Manufacturers will have to conduct stability studies for approximately two years and then wait for six months to one year for FDA approval. Manufacturers have asked other states to give them an exemption to allow for either FDA approval or some timeframe that will allow the free market to decide what products should be made available to patients. The manufacturers support the concept of SB 261 and the need for these devices. Their primary concern is for patient and physician access to needle products. SENATOR ELTON pointed out that the proposed amendment provides for a three-year period for manufacturers of pre-filled syringe devices to comply. He said he does not think any committee member will be unwilling to make additional adjustments if "hiccups" occur. MR. MATER explained that one of the manufacturers' concerns is that as more and more consolidation occurs in the pharmaceutical industry, products are being brought in from abroad. Because those products have not gone through the entire FDA process, SB 261 may limit product access to individuals. He wanted to encourage some forethought as far as the timeframe for getting FDA approval, rather than include a specific date. CHAIRMAN MILLER repeated his intent to hear SB 261 as the first item of business before the committee on March 20. The committee will take testimony, discuss proposed amendments, and hopefully move the bill on to its next committee of referral. He then adjourned the meeting at 2:48 p.m.