State Laws on Pharmaceutical Marketing and Promotion

According to the National Conference of State Legislatures (NCSL), five states (California, Maine, Minnesota, Vermont, and West Virginia) and the District of Columbia have enacted laws affecting pharmaceutical marketing and advertising practices. So far, only Maine has passed laws this year affecting pharmaceutical marketing. Maine is one of the five states that have existing laws regulating pharmaceutical advertising and marketing.

In 2005, twenty eight states (AR, CA, CT, FL, HI, IL, IA, ME, MA, MN, MT, MS, NV, NH, NJ, NY, NM, OH, OK, OR, PA, RI, SC, TN, VT, WA, WI, and WY) proposed legislation to address marketing and direct-to-consumer advertising of pharmaceuticals.

A summary of the new and existing laws follows:

California

California passed two laws in 2004 regulating the marketing and advertising practices of pharmaceutical companies:

SB 1765, effective 7/1/05, requires pharmaceutical companies to:

  • adopt a Comprehensive Compliance Program that is in accordance with the US Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) publication "Guidance and the Pharmaceutical Research and Manufacturers of America Code;"

  • adopt policies on marketing interactions with health care professionals;

  • set limits on gifts and incentives to medical or health professionals, including "specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or health care professional;" and

  • publish annual declarations of compliance on company websites, including a toll-free telephone number where a copy or copies of the Comprehensive Compliance Program and written declaration of compliance may be obtained.

SJR 24 requests the President and U.S. Congress to recognize the problems caused by direct-to-consumer advertising of prescription drugs by pharmaceutical companies and to take specified actions in the regulation of consumer advertising of prescription drugs.

Maine

Maine passed three laws in 2005 addressing pharmaceutical marketing and direct-to-consumer advertising:

LR 487/LD 1618: prohibits pharmaceutical companies from advertising on television, radio or in print unless material meets federal guidelines; includes clinical trial requirements that manufacturers "shall post on the public website of the federal National Institutes of Health or another publicly accessible website information concerning any clinical trial that the manufacturer conducted or sponsored beginning October 15, 2002; and includes a fee for prescription drug manufacturers that advertise in the state for maintaining the clinical trial database.

LR 1703/LD 1539: limits the pricing information that a pharmaceutical manufacturer must report to the state the average manufacturer price (AMP) and the best price as defined by federal law; eliminates the instructions on calculating other pharmaceutical pricing information and the requirement to describe the methodology for calculating pricing information that is reported; and strengthens the confidentiality protections afforded to the reported information.

LR 1703/LD 1541: delays implementation of the deadline for filing reports regarding marketing activities by pharmaceutical manufacturers; and clarifies that the Department of Health and Human Services may disclose that information to an entity that provides services to the department under the laws requiring those reports, but specifies that such disclosure does not change the confidential status of the information.

In 2003, Maine passed LD 254/H 209. The law requires manufacturers or labelers of prescription drugs to file annual reports with the department of Human Services and requires manufacturers to be fined for failure to report. The report should specify the "value, nature, purpose, and recipient expenditures" for:

A. All advertising expenses

B. With regard to all persons and entities licensed to provide health care in this State, the cost of:

  1. educational or informational programs;

  2. food, entertainment, gifts valued at more than $25;

  3. trips and travel; and

  4. product samples, except for free patient samples

C. The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed above, including all forms of payment to those employees within the state

Exemptions: expenses of $25 or less; compensation and reimbursement of expenses for bona fide clinical trial activities; and scholarships and expenses for attending educational or policy conferences if the attendee was chosen by the sponsoring organization.

Minnesota

Enacted in 1993, Minnesota law (151.461) prohibits manufacturers or wholesale drug distributor, and their agents from giving any gift of value to a practitioner. "Gifts" do not include:

  • professional samples of a drug provided to a prescriber for free distribution to patients;

  • items with a total combined retail value, in any calendar year, of not more than $50;

  • a payment to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is not made directly to a practitioner and is used solely for bona fide educational purposes;

  • reasonable honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting;

  • compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project;

  • publications and educational materials; or

  • salaries or other benefits paid to employees.

Vermont

Vermont passed a bill (H. 768) in 2004 requires pharmaceutical marketers to: disclose to health care professionals the prescription drug average wholesale prices (AWP), including a comparison of the AWP to other drugs in the same therapeutic class; and report gifts and marketing expenditures to the Attorney General.

A second bill (H.31) passed in 2002 that: 1) implements education programs, including a counterdetailing program, designed to provide information and education on the therapeutic and cost-effective utilization of prescription drugs to physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs; 2) requires pharmaceutical manufacturers to annually (on or before January 1) disclose to the state (Vermont Board of Pharmacy) the "value, nature and purpose" of their marketing activities in the state. It covers most gifts, fees and payments over $25 made to doctors or other health professionals (anyone in Vermont authorized to prescribe, dispense, or purchase prescription drugs in the state), with a $10,000 penalty for violations. Free samples, clinical trials, material having a value less than $25 and scholarship funding are exempt from disclosure. Trade secrets are to be kept confidential. The Board shall provide to the Office of the Attorney General complete access to the information required to be disclosed under this subsection. The Office of the Attorney General shall report annually on the disclosures made under this section to the General Assembly and the Governor on or before March 1.

West Virginia

West Virginia enacted two laws in relations to pharmaceutical advertising and marketing:

HB. 4084 of 2004 requires reporting of pharmaceutical advertising costs.

SB. 127 of 2001, states that the West Virginia Public Employees Insurance Agency may explore "requiring prescription drug manufacturers to disclose to the state expenditures for advertising, marketing and promotion, as well as for provider incentives and research and development efforts."

District of Columbia

In 2004, the District of Columbia passed B15-569. The law requires manufacturers and labelers to disclose and file annual reports (by July 1) all prescription drug marketing costs, with some exceptions, to the Department of Health. The report shall specify the "value, nature, purpose and recipient of expense" for:

A. All advertising, marketing and direct promotion

B. With regard to all persons and entities licensed to provide health care in this State, the cost of:

  1. educational or informational programs;

  2. food, entertainment, gifts valued at more than $25;

  3. trips and travel; and

  4. product samples, except for free patient samples

C. The aggregate cost of all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed above, including all forms of payment to those employees within the state Exemptions: expenses of $25 or less; compensation and reimbursement of expenses for bona fide clinical trial activities; and scholarships and expenses for attending educational or policy conferences if the attendee was chosen by the sponsoring organization.

Source: National Conference of State Legislators (NCSL), CA, DC, ME, MN, VT, WV State laws, and The Food and Drug Law Institute (FDLI) report, "New Sheriffs On The Block: Growing Number of State Laws Target drug Marketing and Promotion," by Sandra Cohen Kalter and Kelly N. Reeves.