Report Title:

Health; New Drugs; Clinical Testing

Description:

Requires the manufacturer or sponsor of clinical testing of a new drug to report data to DOH and to ClinicalTrials.gov and to notify the person to whom a new drug is being administered and the person's primary care physician where they can obtain the data.

THE SENATE

S.B. NO.

897

TWENTY-THIRD LEGISLATURE, 2005

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to new drugs.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. Section 328-17, Hawaii Revised Statutes, is amended as follows:

1. By amending subsection (d) to read:

"(d) The director shall [promulgate regulations] adopt rules for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. [Such regulations may, within the discretion of the director,] The rules, among other conditions relating to the protection of the public health[,] within the discretion of the director, [provide for conditioning such] shall condition an exemption upon:

(1) [the] The submission to the director before any clinical testing of a new drug is undertaken, of any reports, by the manufacturer or the sponsor of the investigation of [such] the new drug, of preclinical tests (including tests on animals) of [such] the new drug adequate to justify the proposed clinical testing;

(2) [the] The manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each [of such investigators] investigator that patients to whom the drug is administered [will] shall be under [his] the investigator's personal supervision, or under the supervision of [investigators] someone responsible to [him] the investigator, and that [he] the investigator [will] shall not supply [such] the new drug to any other investigator, or to clinics, for administration to human beings; [and]

(3) [the] The establishment and maintenance of [such] records, and the making of [such] reports to the director by the manufacturer or the sponsor of the investigation of [such] the new drug, of data (including but not limited to analytical reports by investigators) obtained as the result of [such] the investigational use of [such drugs,] the new drug, [as] so the director [finds will enable him to] can evaluate the safety and effectiveness of [such] the new drug in the event of the filing of an application pursuant to subsection (b)[.];

(4) [Such regulations shall provide that [such] an exemption shall be conditioned upon the] The manufacturer, or the sponsor of the investigation, requiring that [experts] an expert using [such drugs] a new drug for investigational purposes to certify [to such manufacturer or sponsor] that [they will] the expert shall inform any person to whom [such drugs,] a new drug, or any [controls] control used in connection therewith, [are] is being administered, or [their representatives,] the person's representative, that [such drugs are] the new drug is being used for investigational purposes and that the expert [will] shall obtain the consent of [such] the person or [their representatives] the person's representative[, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such person.]; and

(5) The manufacturer, or the sponsor of the investigation, reporting data, including but not limited to analytical reports by investigators, obtained as the result of the investigational use of the new drug to the web site developed by the U.S. National Institutes of Health in collaboration with the Food and Drug Administration known as ClinicalTrials.gov, or its successor, and notifying the person to whom a new drug, or any control used in connection therewith, is being administered, or the person's representative, and the person's primary care physician, in writing, where the data can be obtained."

2. By amending subsection (f) to read:

"(f) The director [may], after affording an opportunity for hearing, may revoke an application approved pursuant to this section if [he] the director finds that the drug, based on evidence acquired after such approval, may not be safe or effective for its intended use, or that the facilities or controls used in the manufacture, processing, or labeling of such drug may present a hazard to the public health."

SECTION 2. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun, before its effective date.

SECTION 3. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 4. This Act shall take effect upon its approval.

INTRODUCED BY:

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