Date: 03/13/2014
Final
BILL SUMMARY for HB14-1281
HOUSE COMMITTEE ON HEALTH, INSURANCE, & ENVIRONMENT
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10:26 PM -- HB 14-1281
Representative McCann called the committee back to order. Representative Ginal presented House Bill 14-1281. Representative Ginal provided an informational packet (Attachment KK) to the committee. The bill allows, but does not require, eligible patients to participate in clinical trials and use investigational drugs, biological products, and devices. The bill defines an eligible patient as a person who has:
140313 AttachKK.pdf
- a terminal illness;
- considered all other treatment options currently approved by the U.S. Food and Drug Administration;
- given written, informed consent for the use of the investigational drug, biological product, or device; and
- documentation from his or her physician that he or she meets the definition of "eligible patient."
The bill clarifies that a health insurance carrier is not required to pay for the investigational drug, biological product, or device. The bill prohibits any action against a physician's license for his or her recommendation regarding the use of investigational drugs, biological products, or devices.
10:38 PM
Representative Joshi, who is the co-prime sponsor of the bill, made remarks about the bill. Representatives Ginal and Joshi responded to questions about the bill.
10:51 PM -- Larry Sarner, representing himself, testified against the bill. He discussed his concerns about the state's ability to allow exceptions to drug regulatory laws and possible unscrupulous activities that could occur with the enactment of the bill.
10:55 PM -- Maureen Maker, representing Colorado Citizens for Science in Medicine, testified against the bill. She discussed her experience as a cancer patient, her concerns about the consent process, and the safety of investigational drugs. Representative Ginal dialogued with Ms. Maker about the bill.
11:04 PM -- Dr. Bill Marsh, representing Kaiser Permanente, testified against the bill. He discussed his concerns about the bill related to the payments for investigational drugs, whether states can circumvent the federal drug approval process, whether physicians would be held liable for not allowing a patient to try an investigational drug, and the impact using investigational drugs may have on hospice patients.
11:07 PM -- Dr. Joshua Gordon, representing Kaiser Permanente, testified against the bill. He discussed clinical drug trial phases. Dr. Gordon responded to questions about the existing investigational drug approval process.
11:15 PM -- Lorraine McCartin, representing herself, testified in support of the bill. She discussed being a cancer patient and her experience with investigational drugs.
11:22 PM -- Phil McCartin, representing himself, testified in support of the bill. He discussed clinical drug trials and compassionate use of investigational drugs.
11:26 PM
Ms. McCartin and Mr. McCartin responded to questions about the consent form Ms. McCartin signed before she took the investigational drug and the investigational drug she took.
11:29 PM -- Steven Walker, representing the Abigail Alliance, testified in support of the bill. He discussed the investigational drug approval and use process. Mr. Walker responded to questions about physician liability and patient safety. He discussed his wife who was unable to access investigational drugs. Mr. Walker responded to questions about possible federal action concerning investigational drugs.
11:43 PM -- Kurt Altman, representing the Goldwater Institute, testified in support of the bill. He discussed physician liability. Mr. Altman responded to questions about how a physician would know what investigational drug might be appropriate for a patient. Representative Ginal discussed the website ClinicalTrials.gov. Mr. Altman responded to questions about who would pay for the costs associated with side effects from investigational drugs.
11:53 PM -- Janet Stephens, representing the Colorado Hospital Association, testified in a neutral capacity. She read from a written statement (Attachment LL) that was distributed to the committee.
140313 AttachLL.pdf
11:57 PM -- David Blake, representing the Colorado Attorney General's Office, testified in a neutral capacity. He discussed potential conflicts between the bill and federal law. Mr. Blake discussed his concerns about the bill's immunity provisions in response to a question. Mr. Blake discussed the similarity of enacting the bill to legalizing marijuana.
12:07 AM
Representative Primavera read a statement from Beth Davis representing the Colorado Center for Hospice and Palliative Care (Attachment MM).
140313 AttachMM.pdf
12:11 AM
Representative McCann distributed a written statement from Marc Reece, representing the Colorado Association of Health Plans (Attachment NN). Representative Joshi discussed hospice care. Representative McCann laid the bill over for action until a future date.
140313 AttachNN.pdf
12:14 AM
The committee adjourned.