Prescription Drug Ethical Marketing Act
Summary: The Prescription Drug Ethical Marketing Act requires drug manufacturers to disclose the value, nature and purpose of gifts to doctors.
SECTION 1. SHORT TITLE
This Act shall be called the “Prescription Drug Ethical Marketing Act.”
SECTION 2. FINDINGS AND PURPOSE
(A) FINDINGS—The legislature finds that:
1. Prescription drugs are the fastest growing component of health care spending in the United States.
2. Drug manufacturers’ marketing to doctors, or “detailing,” causes doctors to prescribe the most expensive medicines, even when less expensive drugs are as effective or safer.
3. Gifts from prescription drug detailers to doctors play a major role in persuading doctors to change which drugs they prescribe.
(B) PURPOSE—This law is enacted to lower prescription drug costs for individuals, businesses and the state—and to protect the health of residents—by deterring the practice of unethical gift-giving by drug manufacturers.
SECTION 3. PRESCRIPTION DRUG ETHICAL MARKETING
After section XXX, the following new section XXX shall be inserted:
(A) DEFINITIONS—in this section:
1. “Pharmaceutical marketer” means a person who, while employed by or under contract to represent a manufacturer or labeler, 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 or dispense prescription drugs.
2. “Secretary” means the Secretary of the Department of [Health], or the Secretary’s designee.
3. “Manufacturer” means a manufacturer of prescription drugs as defined in 42 U.S.C. Section 1396r-8 (k)(5), including a subsidiary or affiliate of a manufacturer.
4. “Labeler” means an entity or person that receives prescription drugs from a manufacturer or wholesaler to repackage for retail sale, and that has a labeler code from the Food and Drug Administration under 21 C.F.R. Section 207.20.
(B) DISCLOSURE OF MARKETING PRACTICES
1. On or before January 1 of each year, every manufacturer and labeler that sells prescription drugs in the state shall disclose to the Secretary the name and address of the individual responsible for the company’s compliance with the provisions of this section.
2. On or before February 1 of each year, every manufacturer and labeler that sells prescription drugs in the state shall file a marketing disclosure report with the Secretary listing the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit provided in connection with detailing, promotion 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 [State] authorized to prescribe or dispense prescription drugs. Each gift recipient shall be clearly identified by full name and address. The marketing disclosure report shall cover the prior year and be submitted on paper and in a standardized electronic database format prescribed by the Secretary.
3. On or before February 15 of each year, the Secretary shall make the marketing disclosure reports available to the public on paper and through the Internet.
4. The following shall be exempt from disclosure:
a. Any gift, fee, payment, subsidy or other economic benefit worth less than 25 dollars.
b. Free samples of prescription drugs to be distributed to patients.
c. The payment of reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial conducted in connection with a research study designed to answer specific questions about vaccines, new therapies, or new uses of known treatments.
d. Scholarship or other support for medical students, residents and fellows to attend a bona fide educational, scientific or policy-making conference of an established professional association, if the recipient of the scholarship or other support is selected by the association.
(C) ADMINISTRATION AND ENFORCEMENT
1. This section shall be enforced by the Secretary, who shall promulgate such regulations as needed to implement and administer compliance, including regulations describing bona fide clinical trials in section (B)4c and bona fide conferences in section (B)(4)(d).
2. If a manufacturer or labeler violates this section, the Secretary may bring an action in court for injunctive relief, costs, attorneys’ fees, and a civil penalty of up to $10,000 per violation. Each unlawful failure to disclose shall constitute a separate violation.
SECTION 4. EFFECTIVE DATE
This Act shall take effect on July 1, 2007. Initial disclosure shall be made on or before February 1, 2008 for the six-month period July 1, 2007 to December 31, 2007.
Prescription Privacy Act
Summary: The Prescription Privacy Act prohibits the sale of information listed on prescriptions that identifies specific prescribers or patients.
SECTION 1. SHORT TITLE
This Act shall be called the “Prescription Privacy Act.”
SECTION 2. PRESCRIPTION PRIVACY
After section XXX, the following new section XXX shall be inserted:
(A) PRESCRIPTION PRIVACY—Information that identifies a specific prescriber or patient on a prescription shall not be transferred by any pharmacy, pharmacy benefits manager, insurance provider, data transfer intermediary, or their agents.
(B) EXCEPTIONS—If no payment is received for the disclosure, information that identifies a specific prescriber or patient on a prescription may be released to:
1. The patient for whom the original prescription was issued.
2. A licensed prescriber who issued the prescription or who treats the patient.
3. An officer, inspector or investigator for a government health, licensing or law enforcement agency.
4. A person authorized by a court order to receive the information.
5. A pharmacy or medical researcher who has written authorization signed by the patient or the patient’s legal guardian to receive such information.
6. Another pharmacy, for the limited purpose of preventing individuals from misusing or falsifying prescription forms to illegally obtain excessive or unauthorized drugs.
7. The patient’s insurance provider or the provider’s agent, for the limited purpose of reimbursing the pharmacy.
(C) ENFORCEMENT
1. This section shall be enforced by the [Secretary of Health], who shall promulgate such regulations as are necessary to implement and administer compliance.
2. If any person violates this section, the [Secretary of Health] may bring an action in court for injunctive relief, costs, attorneys’ fees, and a civil penalty of up to $1,000 per violation. Each unlawful disclosure shall constitute a separate violation.
SECTION 3. EFFECTIVE DATE
This Act shall take effect on July 1, 2007.