SF 2114

as introduced - 85th Legislature (2007 - 2008) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; requiring disclosure of clinical trials for prescription drugs;
proposing coding for new law in Minnesota Statutes, chapter 144.

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

Section 1.

new text begin [144.6601] CITATION.
new text end

new text begin This act may be cited as the "Patient Safety and Drug Review Transparency Act."
new text end

Sec. 2.

new text begin [144.6602] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Scope of definitions. new text end

new text begin The terms used in sections 144.6602 to
144.6605 have the following meanings, unless the context indicates otherwise.
new text end

new text begin Subd. 2 new text end

new text begin Clinical trial. new text end

new text begin "Clinical trial" means any pharmacological, pharmacokinetic,
or other study of the safety or efficacy of a pharmaceutical drug, biological product, or
vaccine that has been approved for sale by the federal Food and Drug Administration,
whether or not completed in full, except for Phase 1 trials as defined in Code of Federal
Regulations, title 21, section 312.21(a), or any successor regulations, including, but not
limited to:
new text end

new text begin (1) a clinical investigation that involves any trial to test the safety or efficacy of a
pharmaceutical drug or biological product with one or more human subjects and that
is intended to be submitted to, or held for inspection by, the federal Food and Drug
Administration as part of any application for a research or marketing permit or for any
other type of application, permit, procedure, or requirement of the Food and Drug
Administration, including, but not limited to, an abbreviated new drug application, an
investigational new drug application, a new drug application, nonconfidential additions to
the drug master file, postmarketing adverse events recording, and compliance with the
electronic or paper common technical document;
new text end

new text begin (2) any pharmacological study subsequent to initial approval for sale by the Food
and Drug Administration, including studies assessing potential off-label applications and
new drug trials assessing the efficacy or safety of a drug compared to other therapies; and
new text end

new text begin (3) any other study cited or relied upon by a manufacturer for claims made in
marketing or educational efforts or materials to prescribers or consumers.
new text end

new text begin Subd. 3. new text end

new text begin Manufacturer. new text end

new text begin "Manufacturer" means a manufacturer of prescription
drugs or biological products or an affiliate of the manufacturer.
new text end

Sec. 3.

new text begin [144.6603] DISCLOSURE OF CLINICAL TRIALS OF PRESCRIPTION
DRUGS.
new text end

new text begin Subdivision 1. new text end

new text begin Information to be disclosed. new text end

new text begin A manufacturer of prescription drugs
shall make publicly available, in accordance with subdivision 3, the following information
regarding clinical trials conducted or sponsored by the manufacturer, or any entity on its
behalf, for each prescription drug the manufacturer sold, delivered, dispensed, offered for
sale, or gave away in this state:
new text end

new text begin (1) the names of all participating organizations and funding sources of the clinical
trial, including the name and contact information, including institutional affiliation, of all
sponsors, cosponsors, and administrators, including the name of the principal investigators
and study centers, of the clinical trial;
new text end

new text begin (2) a summary of the purpose of the clinical trial, including the name of the drug
being tested and its active ingredients; overall design of the study, including statistical
method to be employed; status or phase type of the trial; inclusion and exclusion criteria;
treatment methods to be used; all hypotheses tested by the trial; the medical condition or
conditions being studied; and outcomes that were evaluated;
new text end

new text begin (3) the dates during which the trial took place; and
new text end

new text begin (4) a summary of information concerning the results and outcomes of the clinical
trial, which shall also include, but not be limited to, specific data and information about
the potential or actual adverse effects of the drug, including the frequency, severity, and
nature of adverse events for any trial participant and the numbers of participants who
discontinued participation in the trial and the reasons for their discontinuance. For any
clinical trial that is terminated, a description of the reasons leading to the decision to
terminate the trial, including whether efficacy, adverse events, or safety issues were factors.
new text end

new text begin Subd. 2. new text end

new text begin Application. new text end

new text begin The disclosure requirement in subdivision 1 shall apply
to all clinical trials completed or terminated on or after January 1, 1990, including any
clinical trials completed after a prescription drug has been approved for sale by the federal
Food and Drug Administration.
new text end

new text begin Subd. 3. new text end

new text begin Information to be posted. new text end

new text begin The information required to be disclosed under
subdivision 1 shall be posted on the publicly accessible Web site. In order to satisfy the
requirements of this subdivision, the publicly accessible Web site and manner of posting
must be acceptable to the commissioner and shall be a free, nonsubscription Web site that
clearly indicates the location and instructions for downloading the files or information
submitted under subdivision 1.
new text end

new text begin Subd. 4. new text end

new text begin Disclosure of terminated trials. new text end

new text begin Disclosure of clinical trials under
subdivision 1 shall include clinical trials that the manufacturer, or an entity on its behalf,
initiated but terminated prior to completion. For these trials, the manufacturer shall
include an explanation for the termination of the trial, including, but not limited to,
potential or actual adverse effects of the drug, including the frequency, severity, and nature
of adverse events for any trial participant and numbers of participants who discontinued
participation in the trial and the reasons for their discontinuance.
new text end

Sec. 4.

new text begin [144.6604] FEES.
new text end

new text begin Beginning January 1, 2008, each manufacturer of prescription drugs that are
provided to state residents through the medical assistance program shall pay a fee of
$1,000 per calendar year to the commissioner. Fees collected under this section are
appropriated to the commissioner to cover the cost of overseeing implementation of
sections 144.6602 to 144.6605, including, but not limited to, maintaining links to publicly
accessible Web sites to which manufacturers are posting clinical trial information under
section 144.6603 and other relevant sites.
new text end

Sec. 5.

new text begin [144.6605] COMPLIANCE DATES.
new text end

new text begin A manufacturer shall post the information required by section 144.6603 as follows:
new text end

new text begin (1) for trials completed or terminated before the effective date of sections
144.6602 to 144.6605, within six months after the effective date of sections 144.6602 to
144.6605, or six months after the date of approval for sale by the federal Food and Drug
Administration, whichever is later;
new text end

new text begin (2) for trials completed or terminated after the effective date of sections 144.6602 to
144.6605, within six months after the date of approval for sale by the federal Food and
Drug Administration, or six months after the date on which the trial was completed,
whichever is later;
new text end

new text begin (3) for trials whose results are being submitted for publication to a peer-reviewed
medical journal, the dates in clauses (1) and (2) may be extended to facilitate publication.
The final extended compliance date shall not exceed 12 months after the trial is completed
or terminated. The manufacturer shall post the required information not later than the
earlier of:
new text end

new text begin (i) 30 days after the time of publication; or
new text end

new text begin (ii) 30 days after receipt of a rejection for publication unless the paper is submitted
to another peer-reviewed journal for publication.
new text end

new text begin If a manufacturer wishes to use the extended compliance date, it shall post notice on
a publicly accessible Web site within the time frames specified in items (i) and (ii) that it is
seeking publication in a peer-reviewed journal and the notice shall include the names and
affiliations of all authors of the study and the names of the peer-reviewed journals that
are considering publication of the paper.
new text end