HB 703-FN – AS INTRODUCED
2005 SESSION
01/09
HOUSE BILL 703-FN
AN ACT relative to advertisement of prescription drugs and establishing the pharmaceutical marketing disclosure law.
SPONSORS: Rep. DeJoie, Merr 11; Rep. Dexter, Ches 6; Rep. Pilliod, Belk 5; Rep. Matthew Quandt, Rock 13; Sen. Letourneau, Dist 19; Sen. D'Allesandro, Dist 20; Sen. Larsen, Dist 15
This bill clarifies advertisements for prescription drugs. This bill also requires pharmaceutical manufacturers to disclose certain information to the secretary of state.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
05-0282
01/09
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Five
AN ACT relative to advertisement of prescription drugs and establishing the pharmaceutical marketing disclosure law.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Pure Food and Drugs; Prohibited Acts; Misleading Added. Amend RSA 146:1, IV to read as follows:
IV. The dissemination of any false or misleading advertisement.
2 False Advertisement. Amend RSA 146:9, II to read as follows:
II. The advertisement of a drug or device [representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, chloecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia or venereal disease, shall also be deemed to be false; except that no advertisement not in violation of paragraph I of this section shall be deemed to be false under this section if it shall be disseminated only to members of the medical, dental or veterinary profession, or shall appear only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs or devices; provided, whenever the commissioner shall agree that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the commissioner shall, by regulation, authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the commissioner may deem necessary in the interests of public health; provided, this section shall not be construed as indicating that self-medication for disease other than those named herein is safe or efficacious] which requires a prescription for use shall also be considered false or misleading.
3 New Chapter; Pharmaceutical Marketing Disclosure Law. Amend RSA by inserting after chapter 5-C the following new chapter:
CHAPTER 5-D
PHARMACEUTICAL MARKETING DISCLOSURE LAW
5-D:1 Definitions. In this chapter:
I. “Clinical trial” means an approved clinical trial conducted in connection with a research study designed to answer specific questions about vaccines, new therapies, or new ways of using known treatments.
II. “Pharmaceutical marketer” means a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in pharmaceutical detailing, promotional activities, or other marketing of prescription drugs in this state to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe, dispense, or purchase prescription drugs. The term shall not include a wholesale drug distributor or the distributor’s representative who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug.
III. “Pharmaceutical manufacturing company” means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs. The term shall not include a wholesale drug distributor or pharmacist licensed under this chapter.
IV. “Trade secret information” includes but is not limited to, any formula, plan, pattern, process, tool, mechanism, compound, procedure, production data, or compilation of information which is not patented, which is known only to certain individuals within a commercial concern, and which gives its user or owner an opportunity to obtain business advantage over competitors who do not know it or use it.
5-D:2 Pharmaceutical Marketers.
I.(a) Annually on or before January 1 of each year, every pharmaceutical manufacturing company shall disclose to the secretary of state 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 company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator or any other person in this state authorized to prescribe, dispense, or purchase prescription drugs. Disclosure shall be made on a form and in a manner prescribed by the secretary of state. The secretary of state shall provide to the office of the attorney general complete access to the information required to be disclosed under this subparagraph. The secretary of state shall report annually on the disclosures made under this section to the general court and the governor on or before March 1.
(b) Each company subject to the provisions of this section shall also disclose to the secretary of state, on or before July 1, 2006 and annually thereafter, the name and address of the individual responsible for the company’s compliance with the provisions of this section.
(c) The secretary of state shall keep confidential all trade secret information. The disclosure form prescribed by the secretary of state shall permit the company to identify any information that is a trade secret.
(d) The following shall be exempt from disclosure:
(1) Free samples of prescription drugs intended to be distributed to patients.
(2) The payment of reasonable compensation and reimbursement of expenses in connection with bona fide clinical trials.
(3) Any gift, fee, payment, subsidy or other economic benefit the value of which is less than $25.
(4) Scholarship or other support for medical students, residents and fellows to attend a significant educational, scientific or policy-making conference of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.
II. The attorney general may bring an action in superior court for injunctive relief, costs, and attorneys fees, and to impose on a pharmaceutical manufacturing company that fails to disclose as required under this section a civil penalty of no more than $10,000 per violation. Each unlawful failure to disclose shall constitute a separate violation.
4 Effective Date. This act shall take effect January 1, 2006.
LBAO
05-0282
Revised 2/17/05
HB 703 FISCAL NOTE
AN ACT relative to advertisement of prescription drugs and establishing the pharmaceutical marketing disclosure law.
FISCAL IMPACT:
The Legislative Budget Assistant has determined that this legislation has a total fiscal impact of less than $10,000 in each of the fiscal years 2005 through 2009.