Citations Affected:
IC 16-18-2
;
IC 16-42-21-2; IC 16-42-25
;
IC 25-26-13-4
.
Synopsis: Drug company reports of gifts. Requires pharmaceutical
manufacturers to report information concerning gifts and payments that
are made to a person who prescribes or purchases prescription drugs.
Excludes certain gifts and payments from disclosure. Provides that
failure to disclose required information is a Class A infraction. Repeals
a definition superseded by this act.
Effective: July 1, 2003.
January 23, 2003, read first time and referred to Committee on Public Health.
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
compounding, encapsulating, entableting, or other process; or
(2) packages or repackages legend drugs.
(b) The term does not include pharmacists or practitioners (as
defined in section 288(a) and 288(c) of this chapter) in the practice of
their profession.
recipient of the scholarship or other support is selected by the
association.
Sec. 5. (a) Before October 15 of each year, each manufacturer
shall disclose, for the preceding twelve (12) month period ending
June 30, to the board the value, nature, and purpose of any gift,
fee, payment, subsidy, or other economic benefit provided in
connection with detailing, promotional or other marketing
activities by the manufacturer or through the manufacturer's
pharmaceutical marketers to any physician, hospital, nursing
home, pharmacist, health benefit plan administrator, or any other
person authorized to prescribe, dispense, or purchase legend drugs
in Indiana.
(b) Each manufacturer subject to this chapter shall annually
disclose to the board the name and address of the individual
responsible for the manufacturer's compliance with the provisions
of this chapter.
Sec. 6. (a) The board shall provide to the office of the attorney
general complete access to the information disclosed under section
5 of this chapter.
(b) Before February 1 of each year, the office of the attorney
general shall report to the general assembly and the governor on
the manufacturers' disclosures made the preceding year under this
chapter.
Sec. 7. (a) The board and the office of the attorney general shall
keep confidential all trade secrets (as defined by
IC 24-2-3-2
)
identified under this chapter.
(b) The disclosure form prescribed by the board must allow the
manufacturer to identify any information that is a trade secret.
Sec. 8. (a) A person who violates this chapter commits a Class
A infraction.
(b) The attorney general may bring an action for injunctive
relief, costs, and attorney's fees against a manufacturer that fails
to disclose information as required under section 5 of this chapter.
(c) Each failure to disclose information required under section
5 of this chapter constitutes a separate violation.
licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permit or
place on probation or fine any licensee or permittee under this
chapter;
(4) regulate the sale of drugs and devices in the state of Indiana;
(5) impound, embargo, confiscate, or otherwise prevent from
disposition any drugs, medicines, chemicals, poisons, or devices
which by inspection are deemed unfit for use or would be
dangerous to the health and welfare of the citizens of the state of
Indiana; the board shall follow those embargo procedures found
in
IC 16-42-1-18
through
IC 16-42-1-31
, and persons may not
refuse to permit or otherwise prevent members of the board or
their representatives from entering such places and making such
inspections;
(6) prescribe minimum standards with respect to physical
characteristics of pharmacies, as may be necessary to the
maintenance of professional surroundings and to the protection of
the safety and welfare of the public;
(7) subject to
IC 25-1-7
, investigate complaints, subpoena
witnesses, schedule and conduct hearings on behalf of the public
interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, and subjects
of licensing examinations which shall be given at least twice
annually; and
(9) administer the collection of information from
pharmaceutical manufacturing companies under
IC 16-42-25
;
and
(10) perform such other duties and functions and exercise such
other powers as may be necessary to implement and enforce this
chapter.
(b) The board shall adopt rules under
IC 4-22-2
for the following:
(1) Establishing standards for the competent practice of
pharmacy.
(2) Establishing the standards for a pharmacist to counsel
individuals regarding the proper use of drugs.
(c) The board may grant or deny a temporary variance to a rule it
has adopted if:
(1) the board has adopted rules which set forth the procedures and
standards governing the grant or denial of a temporary variance;
and
(2) the board sets forth in writing the reasons for a grant or denial
of a temporary variance.