House File 503 - Introduced
HOUSE FILE
BY HOGG
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act prohibiting certain gifts from pharmaceutical marketers to
2 persons authorized or licensed to prescribe, dispense,
3 distribute, or purchase prescription drugs, and providing
4 penalties.
5 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
6 TLSB 2507HH 81
7 pf/cf/24
PAG LIN
1 1 Section 1. NEW SECTION. 155A.4A PHARMACEUTICAL MARKETERS
1 2 == PROHIBITION OF GIFTS.
1 3 1. A pharmaceutical marketer shall not offer or provide to
1 4 any practitioner, hospital, health care facility, pharmacist,
1 5 or health benefit plan administrator, or any other person in
1 6 this state authorized or licensed to prescribe, dispense,
1 7 distribute, or purchase prescription drugs, any gift not
1 8 otherwise exempt under this section.
1 9 2. The following gifts are exempt from the prohibition of
1 10 this section:
1 11 a. Free samples of prescription drugs intended for
1 12 distribution to patients.
1 13 b. The payment of reasonable compensation and
1 14 reimbursement of expenses in connection with bona fide
1 15 clinical trials. As used in this paragraph, "clinical trial"
1 16 means a clinical trial approved by an institutional review
1 17 board conducted in connection with a research study designed
1 18 to answer specific questions about vaccines, new therapies, or
1 19 new ways of utilizing known treatments.
1 20 c. Any gift, fee, payment, subsidy, or other economic
1 21 benefit the value of which is less than twenty=five dollars.
1 22 d. A scholarship or other support for medical students,
1 23 residents, or fellows to attend a significant educational,
1 24 scientific, or policymaking conference of a national,
1 25 regional, or specialty medical or other professional
1 26 association if the recipient of the scholarship or other
1 27 support is selected by the association.
1 28 3. a. Annually on or before January 1, every
1 29 pharmaceutical manufacturing company shall disclose to the
1 30 board the value, nature, and purpose of any gift, fee,
1 31 payment, subsidy, or other economic benefit provided in
1 32 connection with detailing, promotional, or other marketing
1 33 activities by the company, directly or through its
1 34 pharmaceutical marketers, to any practitioner, hospital,
1 35 health care facility, pharmacist, or health benefit plan
2 1 administrator, or any other person in this state authorized or
2 2 licensed to prescribe, dispense, distribute, or purchase
2 3 prescription drugs in this state. Disclosure shall be made on
2 4 a form and in a manner prescribed by the board and shall be
2 5 made for the period beginning July 1 and ending June 30 of the
2 6 previous fiscal year. An initial disclosure shall be made on
2 7 January 15, 2006, for the period beginning July 1, 2005, and
2 8 ending December 31, 2005. The board shall provide to the
2 9 office of the attorney general complete access to the
2 10 information required to be disclosed under this subsection.
2 11 The office of the attorney general shall report annually on
2 12 the disclosures made under this section to the governor and
2 13 the general assembly on or before March 1.
2 14 b. Each pharmaceutical manufacturing company subject to
2 15 the provisions of this section shall also disclose to the
2 16 board, on or before October 1, 2005, and annually thereafter,
2 17 the name and address of the individual responsible for the
2 18 company's compliance with this section.
2 19 c. The board and the office of the attorney general shall
2 20 keep confidential all trade secrets as defined in section
2 21 550.2. The disclosure form prescribed by the board shall
2 22 permit the company to identify any information that is a trade
2 23 secret.
2 24 d. A pharmaceutical manufacturing company is exempt from
2 25 disclosure of any gifts that are exempt from the prohibition
2 26 pursuant to subsection 2.
2 27 e. The attorney general may bring an action for injunctive
2 28 relief, costs, and attorney fees, and may impose a civil
2 29 penalty of not more than ten thousand dollars per violation on
2 30 a company that fails to disclose information as required by
2 31 this subsection. Each failure to disclose constitutes a
2 32 separate violation.
2 33 4. For the purposes of this section:
2 34 a. "Pharmaceutical manufacturing company" means any entity
2 35 engaged in the production, preparation, propagation,
3 1 compounding, conversion, or processing of prescription drugs,
3 2 either directly or indirectly by extraction from substances of
3 3 natural origin, or independently by means of chemical
3 4 synthesis, or by a combination of extraction and chemical
3 5 synthesis, or any entity engaged in the packaging,
3 6 repackaging, labeling, relabeling, or distribution of
3 7 prescription drugs. "Pharmaceutical manufacturing company"
3 8 does not include a wholesaler or a pharmacist licensed under
3 9 this chapter.
3 10 b. "Pharmaceutical marketer" means a person who, while
3 11 employed by or under contract to represent a pharmaceutical
3 12 manufacturing company, engages in pharmaceutical detailing,
3 13 promotional activities, or other marketing of prescription
3 14 drugs in this state to any practitioner, hospital, health care
3 15 facility, pharmacist, health benefit plan administrator, or
3 16 any other person licensed or authorized to prescribe,
3 17 dispense, distribute, or purchase prescription drugs.
3 18 "Pharmaceutical marketer" does not include a wholesaler or a
3 19 wholesale salesperson.
3 20 EXPLANATION
3 21 This bill prohibits a pharmaceutical marketer from offering
3 22 or providing to any practitioner, hospital, health care
3 23 facility, pharmacist, or health benefit plan administrator, or
3 24 any other person in the state authorized or licensed to
3 25 dispense, distribute, or purchase prescription drugs, any gift
3 26 not otherwise exempt under the bill.
3 27 The bill specifies the gifts exempt from the prohibition;
3 28 directs pharmaceutical manufacturing companies on an annual
3 29 basis to disclose gifts made to the board of pharmacy
3 30 examiners; directs pharmaceutical manufacturing companies on
3 31 an annual basis to provide the name and address of the
3 32 individual responsible for the company's compliance with the
3 33 bill; provides that all trade secrets are to be kept
3 34 confidential; and authorizes the attorney general to bring an
3 35 action for injunctive relief, costs, and attorney fees and to
4 1 impose a civil penalty for failure of a company to disclose
4 2 required information.
4 3 LSB 2507HH 81
4 4 pf:nh/cf/24