House Committee on Health, Insurance, & Environment (03/05/2015)

Final
STAFF SUMMARY OF MEETING

HOUSE COMMITTEE ON HEALTH, INSURANCE, & ENVIRONMENT

Date:	03/05/2015	ATTENDANCE

Time:	01:36 PM to 06:13 PM	Brown	X
		Esgar	X
Place:	HCR 0107	Humphrey	X
		Joshi	X
This Meeting was called to order by		Klingenschmitt	X
	Representative McCann	Landgraf	X
		Lontine	X
This Report was prepared by		Mitsch Bush	X
	Amanda King	Primavera	X
		Ransom	X
		Ryden	X
		Ginal	X
		McCann	X
		X = Present, E = Excused, A = Absent, * = Present after roll call

Bills Addressed:		Action Taken:
SB15-071		Amended, Referred to the Committee of the Whole

01:37 PM -- SB15-071

Representative McCann and Representative Landgraf presented Senate Bill 15-071. Under current law, a pharmacist can substitute chemical drugs of the same generic drug type if the pharmacist determines that the substituted drug is therapeutically equivalent to and interchangeable with the prescribed drug. The bill permits a pharmacist to also substitute biological drug products that are similarly equivalent and interchangeable with the prescribed biological product. Biological drug products covered by the bill are generally made from human or animal materials, but the bill does not apply to most vaccines and immunizations.

Under the bill, a pharmacist may substitute a biological product for another prescribed biological product if:
• the federal Food and Drug Administration (FDA) has determined that the biological product is interchangeable with the prescribed biological product;
• the biological product costs the purchaser less than the prescribed biological product;
• the prescribing practitioner has not prohibited the pharmacist from making a substitution; and
• the pharmacist communicates information to the prescribing practitioner about the specific biological product dispensed to the patient in a reasonable time frame. This requirement does not apply to certain situations, as specified in the bill.

The pharmacist must also communicate in writing and orally with the patient about the biological product substitution. This disclosure requirement does not apply to institutionalized patients.

Further, the bill requires the State Board of Pharmacy within the Department of Regulatory Agencies to maintain a link on their website to FDA resources identifying approved biological products. Representative Landgraf discussed the physician notification requirement in the bill. An informational packet was distributed to the committee (Attachment A).

150305 AttachA.pdf

01:44 PM

Representative Landgraf and Representative McCann answered questions about the bill. The committee dialogued with the bill sponsors about the physician notification requirement.

02:01 PM

Committee discussion about the bill ensued.

02:07 PM -- Charlie Sheffield, Colorado Chain Pharmacy Committee, testified in opposition to the bill. He provided two handouts (Attachments B and C). He relayed statistics about insulin. He discussed possibly adding a three-year sunset to the physician notification requirement. Mr. Sheffield answered questions about the bill and biological products. Committee discussion continued about the physician notification requirement.

150305 AttachB.pdf

150305 AttachC.pdf

02:25 PM -- Marla Frawner, King Soopers, testified in opposition to the bill. She outlined the timeline for biological products being introduced into the pharmaceutical market and the lack of reference materials for pharmacists about interchanging biological products. She discussed institutionalized patients, the federal Health Insurance Portability and Accountability Act requirements for e-mail communications, and potential liability for the pharmacists when making substitutions. Ms. Frawner answered questions about biological products.

02:38 PM

The committee dialogued with Ms. Frawner about the bill, insulin, and biological products.

02:44 PM

Representative McCann and Representative Landgraf answered question about why the bill is drafted with a safety clause.

02:46 PM

Ms. Frawner answered questions about the costs of biologic products.

02:48 PM -- Brad Young, Rx Plus Pharmacies, testified in opposition to the bill. He stated that his organization supports permitting the substitution of biological products, but opposes the physician notification requirement. He discussed the position of the Colorado Pharmacists Society on the bill. He discussed the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) and the FDA Lists of Licensed Biological Products (Purple Book). He discussed the bill and the physician notification requirement. Mr. Young answered questions about the physician notification requirement and the bill.

03:04 PM -- Bruce Lott, Mylan, testified in opposition to the bill. He discussed interchangeable biological products versus biosimilar products. He discussed insulin, the Orange Book, and the Purple Book. He discussed the lack of FDA guidance on biological product substitutions. He shared information about laws in other states concerning the substitution of interchangeable biological products. Mr. Lott answered questions about the Orange Book, the Purple Book, and the European Medicines Agency. Mr. Lott answered questions about FDA approval of interchangeable biological products and biosimilar products.

03:20 PM -- Rachel Lee, CVS Health, testified in opposition to the bill. She discussed the physician notification provision in the bill and interchangeable biological products. Ms. Lee answered questions about the safety of interchangeable biological products.

03:26 PM -- Virginia Morrison Love, America's Health Insurance Plans, testified in opposition to the bill. She discussed the physician notification provision in the bill. She addressed the cost of biological products and possible liability issues for pharmacists. Ms. Morrison Love answered questions from the committee.

03:32 PM -- Shirley Leow, AARP, testified in opposition to the bill. She discussed how the bill could create barriers for consumers to interchangeable biological products. Ms. Leow answered questions about her organization's position on the bill.

03:38 PM -- April Giles, Colorado BioScience Association, testified in support of the bill. She discussed how the physician notification requirement provides transparency. She stated that 16 states are currently considering legislation about interchangeable biological products. Ms. Giles answered questions about biosimilars. Representative McCann answered questions about the definition of biological products as outlined in the bill. Ms. Giles answered questions about possible patient reactions to biological products. Representative McCann referenced the handout titled Colorado: Biologics Represented 0.31% of Prescriptions Dispensed by Retail Pharmacies in 2013 from the informational packet (Attachment A).

03:47 PM -- Christy Chase, Office of Legislative Legal Services, responded to questions about the definition of interchangeable in the bill and biosimilars.

03:50 PM

In response to questions, Ms. Giles discussed prescriptions for biosimilars and the FDA-approval process.

03:52 PM -- Laura Rosseisen, Arthritis Foundation, testified in support of the bill. She discussed arthritis and the need for physician notification when a substitution of a interchangeable biological products occurs. Ms. Rosseisen answered questions about substitutions of interchangeable biological products. Representative McCann answered questions about whether current law prohibits the substitution of a biological products.

03:58 PM -- Mark Godfrey, Eli Lilly and Company, testified in support of the bill. He shared information about the FDA-approval process for biological products. Mr. Godfrey answered questions about possible merger of the FDA-approval process for biological products in 2020. The committee dialogued with Mr. Godfrey about biological products.

04:12 PM -- Mariah Leach, Global Healthy Living Foundation, testified in support of the bill. She shared her experience taking biological products for rheumatoid arthritis. Ms. Leach answered questions about whether patients could notify physicians of a substitution and the medications she has taken for her condition.

04:20 PM -- Patrick Boyle, Express Scripts, testified in support of the bill. He discussed his organization's position on House Bill 13-1211, concerning the ability of a pharmacist to substitute a biosimilar product for a prescribed biological product when certain conditions are satisfied. He responded to questions from the committee regarding physician liability and the physician notification provision in the bill.

04:26 PM -- Frank Ramirez, International Cancer Advocacy Network, testified in support of the bill. He discussed his diagnosis with cancer and noted that biological products are a very important part of treatment for cancer. He discussed the importance of doctors knowing the particular drugs that are dispensed to patients. He responded to questions from the committee.

04:32 PM -- Paul Thompson, International Cancer Advocacy Network, testified in support of the bill. He stated that there are consequences to the specific drugs that are used in treating patients and discussed his wife's experience with generic medications. Mr. Thompson answered questions from the committee. The committee dialogued with Representative McCann and Mr. Thompson about the physician notification provision in the bill.

04:49 PM -- Eileen Doherty, Colorado Gerontological Society, testified in support of the bill. She discussed patients' rights and the physician notification requirement in the bill.

04:53 PM -- Dr. Mitchell Achee, representing himself, testified in support of the bill. He discussed biological products, the physician notification requirement, and the costs for biological products. Representative Ginal commented on how physicians document adverse events in patient records.

05:02 PM -- Anita Fricklas, representing herself, testified in support of the bill. She shared her experience with several auto-immune diseases. Representative Landgraf answered questions about the sunset review of the pharmacy practice act in 2021.

05:10 PM -- Brian Tobias, Department of Regulatory Agencies, answered questions about sunset review about the pharmacy practice act. He stated that he was not aware if the department has taken a position on the bill. He responded to questions about adding a sunset review to the bill and what the sunset report would potentially address.

05:14 PM -- William Ray, representing himself, testified in support of the bill. He discussed his daughter who has type 1 diabetes.

05:19 PM -- R.J. Ours, American Cancer Society Cancer Action Network, testified in support of the bill. He discussed clarifying what a reasonable time means as the term is used in the bill. He distributed a position paper (Attachment D).

150305 AttachD.pdf

05:23 PM -- Dr. Gino Grampp, Amgen, testified on the bill. He discussed the physician notification requirement in the bill. He discussed the need for transparency and safety concerning biological products. Dr. Grampp answered questions about post-marketing studies for drugs and when a substitution of a biological product might occur. In response to a question, he stated that currently there are no interchangeable biological products approved by the FDA.

05:35 PM -- Mr. Lott returned to the table to answer questions about patient notification of drug substitutions under current law. Mr. Lott dialogued with the committee about how substitutions of biological products would occur if the bill is not enacted.

05:38 PM

Dr. Grampp responded to questions about what would happen if the bill is not enacted and the FDA-approval process for biological products. The committee continued to dialogue with Mr. Lott and Dr. Grampp.

05:48 PM

Representative Landgraf discussed the potential consumer savings the bill could provide.

05:51 PM

Representative Klingenscmitt discussed amendment L.012 (Attachment E). The committee discussed the amendment.

150305 AttachE.pdf


BILL:	SB15-071
TIME:	05:56:12 PM
MOVED:	Klingenschmitt
MOTION:	Adopt amendment L.012 (Attachment E). The motion failed on a vote of 3-10.
SECONDED:	Humphrey
		VOTE
	Brown	No
	Esgar	No
	Humphrey	Yes
	Joshi	Yes
	Klingenschmitt	Yes
	Landgraf	No
	Lontine	No
	Mitsch Bush	No
	Primavera	No
	Ransom	No
	Ryden	No
	Ginal	No
	McCann	No
YES: 3 NO: 10 EXC: 0 ABS: 0 FINAL ACTION: FAIL

05:58 PM

Representative Joshi discussed amendment L.013 (Attachment F). The committee discussed the amendment.

150305 AttachF.pdf


BILL:	SB15-071
TIME:	06:02:45 PM
MOVED:	Joshi
MOTION:	Adopt amendment L.013 (Attachment F). The motion failed on a vote of 6-7.
SECONDED:	Humphrey
		VOTE
	Brown	Yes
	Esgar	No
	Humphrey	Yes
	Joshi	Yes
	Klingenschmitt	Yes
	Landgraf	No
	Lontine	No
	Mitsch Bush	Yes
	Primavera	No
	Ransom	Yes
	Ryden	No
	Ginal	No
	McCann	No

YES: 6 NO: 7 EXC: 0 ABS: 0 FINAL ACTION: FAIL

06:05 PM

Representative Humphrey discussed why the bill was drafted with a safety clause with the bill sponsors.

06:06 PM

Representative McCann and Representative Landgraf made concluding remarks. The committee members discussed the bill.


BILL:	SB15-071
TIME:	06:12:49 PM
MOVED:	McCann
MOTION:	Refer Senate Bill 15-071 to the Committee of the Whole. The motion passed on a vote of 12-1.
SECONDED:	Landgraf
		VOTE
	Brown	Yes
	Esgar	Yes
	Humphrey	Yes
	Joshi	Yes
	Klingenschmitt	No
	Landgraf	Yes
	Lontine	Yes
	Mitsch Bush	Yes
	Primavera	Yes
	Ransom	Yes
	Ryden	Yes
	Ginal	Yes
	McCann	Yes

Final YES: 12 NO: 1 EXC: 0 ABS: 0 FINAL ACTION: PASS

06:13 PM

The committee adjourned.