Sponsored by:
Senator LINDA R. GREENSTEIN
District 14 (Mercer and Middlesex)
SYNOPSIS
"Prescription Drug Right-to-Know Act"; establishes clinical trials registry in DHSS; requires pharmaceutical companies to publicly disclose clinical trial data.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning public access to information about clinical trials and supplementing Title 24 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. This act shall be known and may be cited as the "Prescription Drug Right-to-Know Act."
2. The Legislature finds and declares that:
a. Recent revelations to the general public of potential adverse health effects from using certain prescription drugs have demonstrated a need for the State to better protect New Jersey consumers using pharmaceutical products;
b. In some instances, the drug manufacturer had access to clinical trial data demonstrating serious potential adverse side effects or lack of effectiveness, but did not share that data with the research community or the general public;
c. Physicians and other health care professionals will be better equipped to make sound decisions about medicines, and patients will be better informed about the potential dangers of certain medicines, if all clinical studies of prescription drugs are accessible to the research community and the general public along with the information necessary to understand and critique the studies; and
d. It is the intent of the Legislature, in enacting this act, to require pharmaceutical companies to make public the results of all clinical trials conducted on their drugs if those drugs are made available to New Jersey consumers.
3. As used in this act:
"Adverse event" means a negative health outcome occurring in a clinical trial subject during the course of the clinical trial.
"Clinical trial" means a clinical investigation as defined by the federal Food and Drug Administration that involves an experiment to test the safety or efficacy of a drug or biological product with one or more human subjects.
"Clinical trial funding sources" means the name of and financial contribution amount for each person or entity that provides funding for the clinical trial.
"Commissioner" means the Commissioner of Health and Senior Services.
"Comparator drug" means an investigational or marketed drug or placebo against which a new drug is being tested and compared.
"Completion date" means the date of the last visit by a clinical trial subject necessary for completion of the trial or the date of the first publication of any data from the clinical trial, whichever is earlier.
"Department" means the Department of Health and Senior Services.
"Initiation date" means the date of enrollment of the first clinical trial subject in a clinical trial.
"Outcomes of the clinical trial" means the specific measurements that are taken to evaluate the effects of the drug and any comparator drug on the clinical trial subjects in a particular clinical trial.
"Outcomes to be tested" means the specific measurements that are to be taken to evaluate the effects of the drug and any comparator drug on the clinical trial subjects in a particular clinical trial.
"Pharmaceutical company" means an entity that is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, either directly or indirectly, by means of chemical synthesis or by a combination of extraction and chemical synthesis. "Pharmaceutical company" also means an entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs, and includes a person who engages in pharmaceutical detailing, promotional activities, or other marketing of a prescription drug in this State on behalf of a pharmaceutical company.
"Prescription drug" means a drug which is approved by the federal Food and Drug Administration and commercially available in this State.
"Principal researcher" means a principal clinical investigator responsible for conducting a clinical trial, who, at a minimum, is involved in: hypothesis development; design of the trial protocol; arranging for research support; attending to legal, ethical, and regulatory issues related to the clinical research; enrollment of clinical trial subjects; execution of the clinical trial; and analysis and reporting of the outcomes of the trial.
"Principal sponsor" means the entity that is responsible for funding a clinical trial and designing the trial protocol, and which owns the data generated by the trial.
"Purposes of the clinical trial" means the hypotheses that a clinical trial is testing, including, but not limited to: the effectiveness of a prescription drug in treating a specific, identified illness or condition, and what type of effect is being sought; the safety of that drug when used to treat a specific, identified illness or condition; and the relative effectiveness or safety of the drug in treating a specific, identified illness or condition as compared to another drug, and what type of effect or adverse event is to be compared.
"Registry" means the clinical trials registry established in the Department of Health and Senior Services pursuant to this act.
4. a. The Commissioner of Health and Senior Services shall establish a clinical trials registry to include the information set forth in subsection b. of this section.
b. A pharmaceutical company that sells, delivers, offers for sale or gives away any prescription drug within this State shall register with the Department of Health and Senior Services each clinical trial that the company conducts or sponsors for each prescription drug that the company sells, delivers, offers for sale or gives away in this State. The pharmaceutical company shall submit the following information to the department for inclusion in the registry, on a form and in a manner prescribed by the commissioner, no later than the 30th day after the initiation date:
(1) the name of the clinical trial;
(2) the commercial and chemical name of all prescription drugs to be tested, including any comparator drug;
(3) the dosages to be tested for each drug, including dosages of any comparator drug;
(4) the initiation date and expected completion date of the clinical trial;
(5) the purposes of the clinical trial, including any medical condition to be studied;
(6) the outcomes to be tested, including all time points at which outcome data will be measured;
(7) the clinical trial funding sources;
(8) the number of participants to be enrolled;
(9) a list of all specific characteristics used to include or exclude prospective clinical trial subjects, including, but not limited to, gender, race, age or pre-existing health conditions, and an explanation of why each characteristic was used to include or exclude subjects;
(10) the name and contact information for each principal sponsor of the trial, including, but not limited to, the telephone number, mailing address, and e-mail address for public inquiry;
(11) the name and contact information for each principal researcher engaged in the clinical trial, including, but not limited to, the telephone number, mailing address, and e-mail address for public inquiry;
(12) any financial interest that each principal researcher has in the drugs tested or compared in the clinical trial and in the principal sponsors of the trial;
(13) any other information required for clinical trial registration pursuant to section 113 of the federal "Food and Drug Administration Modernization Act of 1997," Pub.L.105-115; and
(14) any other information required by the commissioner.
c. The department shall make the information contained in the registry available electronically on its Internet website in clearly understandable language that is designed to assist consumers in understanding the content of, and how to access, that information.
d. The commissioner may charge a filing fee to a pharmaceutical company, to be paid with its first submission of information to the department pursuant to subsection b. of this section, in an amount determined necessary by the commissioner, to fund the development and maintenance of the registry and the related information on the Internet website of the department.
e. A pharmaceutical company that registers a clinical trial with the department pursuant to subsection b. of this section shall submit the following information to the department no later than the 90th day after the completion date, on a form and in a manner prescribed by the commissioner:
(1) any changes or updates to the information submitted pursuant to subsection b. of this section that is not otherwise described in paragraph (2) of this subsection; and
(2) the following information:
(a) the outcomes of the clinical trial, including all time points at which the outcome data were measured;
(b) the number of patients initially enrolled in the clinical trial and the number completing the clinical trial;
(c) the frequency, severity, and nature of all adverse events experienced by clinical trial subjects for each drug tested in the clinical trial; and a description of the information regarding adverse events that is included in the package insert for the new drug, including direct quotations from the package insert; and
(d) the citation for any publication in which data from the clinical trial were published, and the name and employer of any author of the published study.
f. A pharmaceutical company that registers a clinical trial with the department pursuant to subsection b. of this section but does not complete the clinical trial shall submit the following information to the department no later than the 90th day after the date that the clinical trial is terminated, on a form and in a manner prescribed by the commissioner:
(1) any changes or updates to the information submitted pursuant to subsection b. of this section that is not otherwise described in paragraph (2) of this subsection; and
(2) the following information:
(a) the date on which the clinical trial was terminated and the reasons for its termination;
(b) the number of patients initially enrolled in the clinical trial and the number enrolled in the clinical trial on the date that the trial was terminated;
(c) the frequency, severity, and nature of all adverse events experienced by clinical trial subjects for each drug tested in the clinical trial; and a description of the information regarding adverse events that is included in the package insert for the new drug, including direct quotations from the package insert; and
(d) the citation for any publication in which data from the clinical trial were published, and the name and employer of any author of the published study.
5. The commissioner shall seek to promote public awareness of the existence and uses of the registry and the information maintained on the Internet website of the department pursuant to this act.
6. Notwithstanding any other provision of the law to the contrary, a person or entity who is required to or authorized by the commissioner to report, receive or disclose information relating to the registry pursuant to this act shall be immune from liability for reporting, receiving or disclosing that information in accordance with the provisions of this act, or any rule or regulation adopted pursuant thereto.
7. a. A pharmaceutical company that violates any provision of this act, or the rules and regulations adopted pursuant thereto, shall be liable to a civil penalty of not less than $250 and not greater than $10,000 for each day that the pharmaceutical company is in violation if:
(1) the commissioner provides the pharmaceutical company with reasonable notice in writing of the commissioner's intent to levy the penalty; and
(2) at the discretion of the commissioner, the pharmaceutical company has 30 days, or such additional time as the commissioner shall determine to be reasonable, to remedy the violation and fails to do so within the time allowed.
b. The civil penalty shall be collected by the commissioner in the name of the State in a summary proceeding pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.); and the proceeds thereof shall be utilized by the commissioner to meet the costs of compiling and maintaining the information contained in the registry and on the Internet website of the department, and to promote public awareness of the existence and uses of the registry.
8. The commissioner shall adopt rules and regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), to effectuate the purposes of this act.
9. This act shall take effect on the 180th day after the date of enactment and shall apply to clinical trials that commence on or after the effective date of this act; however, the commissioner may take such anticipatory administrative action in advance as shall be necessary for the implementation of the act.
STATEMENT
This bill, which is designated the "Prescription Drug Right-to-Know Act," requires prescription drug manufacturers to report clinical trial data to the Department of Health and Senior Services (DHSS), which is to establish a clinical trials registry to include this information and make it accessible to the general public through its Internet website.
The bill provides specifically as follows:
· A pharmaceutical company that sells, delivers, offers for sale or gives away any prescription drug within this State is to register with DHSS each clinical trial that the company conducts or sponsors for each prescription drug that the company sells, delivers, offers for sale or gives away in this State. The pharmaceutical company is to submit the following information to DHSS for inclusion in its clinical trials registry, on a form and in a manner prescribed by the Commissioner of Health and Senior Services, no later than the 30th day after the initiation date of the clinical trial:
(1) the name of the clinical trial;
(2) the commercial and chemical name of all prescription drugs to be tested, including any comparator drug;
(3) the dosages to be tested for each drug, including dosages of any comparator drug;
(4) the initiation date and expected completion date of the clinical trial;
(5) the purposes of the clinical trial, including any medical condition to be studied;
(6) the outcomes to be tested, including all time points at which outcome data will be measured;
(7) the clinical trial funding sources;
(8) the number of participants to be enrolled;
(9) a list of all specific characteristics used to include or exclude prospective clinical trial subjects, including, but not limited to, gender, race, age or pre-existing health conditions, and an explanation of why each characteristic was used to include or exclude subjects;
(10) the name and contact information for each principal sponsor of the trial, including, but not limited to, the telephone number, mailing address, and e-mail address for public inquiry;
(11) the name and contact information for each principal researcher engaged in the clinical trial, including, but not limited to, the telephone number, mailing address, and e-mail address for public inquiry;
(12) any financial interest that each principal researcher has in the drugs tested or compared in the clinical trial and in the principal sponsors of the trial;
(13) any other information required for clinical trial registration pursuant to section 113 of the federal "Food and Drug Administration Modernization Act of 1997"; and
(14) any other information required by the commissioner.
· DHSS is to make the information contained in the registry available electronically on its Internet website in clearly understandable language that is designed to assist consumers in understanding the content of, and how to access, that information.
· The commissioner may charge a filing fee to a pharmaceutical company, to be paid with its first submission of information to DHSS pursuant to the bill, in an amount determined necessary by the commissioner, to fund the development and maintenance of the registry and the related information on the DHSS Internet website.
· A pharmaceutical company that registers a clinical trial with DHSS is to submit the following information to DHSS no later than the 90th day after completion of the clinical trial, on a form and in a manner prescribed by the commissioner:
(1) any changes or updates to the information submitted by the company when it registered the clinical trial; and
(2) the following information:
-- the outcomes of the clinical trial, including all time points at which the outcome data were measured;
-- the number of patients initially enrolled in the clinical trial and the number completing the clinical trial;
-- the frequency, severity, and nature of all adverse events experienced by clinical trial subjects for each drug tested in the clinical trial; and a description of the information regarding adverse events that is included in the package insert for the new drug, including direct quotations from the package insert; and
-- the citation for any publication in which data from the clinical trial were published, and the name and employer of any author of the published study.
· A pharmaceutical company that registers a clinical trial with DHSS but does not complete the clinical trial is to submit the following information to DHSS no later than the 90th day after termination of the clinical trial, on a form and in a manner prescribed by the commissioner:
(1) any changes or updates to the information submitted by the company when it registered the clinical trial; and
(2) the following information:
-- the date on which the clinical trial was terminated and the reasons for its termination;
-- the number of patients initially enrolled in the clinical trial and the number enrolled in the clinical trial on the date that the trial was terminated;
-- the frequency, severity, and nature of all adverse events experienced by clinical trial subjects for each drug tested in the clinical trial; and a description of the information regarding adverse events that is included in the package insert for the new drug, including direct quotations from the package insert; and
-- the citation for any publication in which data from the clinical trial were published, and the name and employer of any author of the published study.
· The commissioner is to seek to promote public awareness of the existence and uses of the registry and the information maintained on the DHSS Internet website pursuant to the bill.
· A person or entity who is required to or authorized by the commissioner to report, receive or disclose information relating to the registry is immune from liability for reporting, receiving or disclosing that information in accordance with the provisions of the bill, or any rule or regulation adopted pursuant thereto.
· A pharmaceutical company that violates any provision of the bill, or the rules and regulations adopted pursuant thereto, is liable to a civil penalty of not less than $250 and not greater than $10,000 for each day that the pharmaceutical company is in violation if: the commissioner provides the pharmaceutical company with reasonable notice in writing of the commissioner's intent to levy the penalty; and, at the discretion of the commissioner, the pharmaceutical company has 30 days, or such additional time as the commissioner determines to be reasonable, to remedy the violation and fails to do so within the time allowed.
· The bill takes effect on the 180th day after enactment and applies to clinical trials that commence on or after the effective date, but authorizes the commissioner to take anticipatory administrative action in advance as necessary for its implementation.