Minnesota may have been the first state to enact a law related to pharmaceutical, but it definitely was not the last. Five states and the District of Columbia already have laws on the books, and new proposed bills are flooding into state legislatures at an ever-increasing volume. Some, such as the pharmaceutical marketing disclosure laws in Maine and Washington, D.C., include CME grants, while others provide exemptions for CME.
On the Books
Minnesota's statue 151.461, passed in 1993, includes a $50 per-physician cap on what pharmaceutical companies can spend in any specific calendar year. It exempts payments “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.” It also exempts “reasonable” honoraria and expenses for conference, and compensation for “the substantial professional or consulting services of a practitioner in connection with a genuine research project,” though it does not further define what constitutes “reasonable” or “genuine.”
In 2004, West Virginia passed HB 4084, which requires pharmaceutical companies to report prescription drug advertising costs. The West Virginia laws do not directly address CME grants, but do exclude scholarship programs for interns and residents, according to Garineh S. Dovletian, Esq., Porzio, Bromberg & Newman, P.C., Morristown, N.J., a law firm that specializes in pharma marketing legislation. While the disclosure law is on the books, Dovletian says it has yet to be implemented, though the state this spring issued draft legislative rules that would make clear the rules and forms necessary for implementation.
The District of Columbia and the state of Maine both passed laws in 2003 that require the disclosure of gifts to physicians, including expenses related to educational or informational programs, Dovletian says. “Those kinds of expenses are subject to disclosure regardless of whether the manufacturer or whoever else is involved in the distribution chain provides the educational or informational session. One interpretation of the statute would be that if a manufacturer provides a CME grant to an independent provider, that would fall under the scope of disclosure” in the Maine and D.C. statutes.
The Maine law also requires disclosure of food, entertainment, and gifts valued at more than $25, and travel. It exempts “scholarships and reimbursement expenses for attending a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar.” This spring, Maine issued proposed regulations for its marketing and clinical trial disclosure laws that would include the names of healthcare providers that receive gifts.
California has been busy in this arena lately, with SB 1765, effective as of July 1, 2005. It requires pharmaceutical companies and medical device manufacturers (a bill in 2005 to exclude the latter was pulled) to implement a compliance program that conforms with the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals and the Office of Inspector General's pharma marketing guidance, and that caps expenditures directed to healthcare providers. There are exemptions to the spending limits that the manufacturers establish in order to comply with this law, including an exemption for CME commercial support, as long as those grants are in compliance with the PhRMA Code as well as the OIG guidance.
Vermont has passed two laws, one in 2002 and another in 2004, that require pharma companies to report gifts and marketing expenditures to the state attorney general. “It is probably the most advanced of the state disclosure laws in that it actually requires that companies synthesize the information and provide reports to the legislature,” says Dovletian. She adds that Vermont's laws exempt from disclosure drug samples, gifts valued at less than $25, scholarships for conferences, and grants for CME.
More on the Horizon
Physician-marketing legislation has been proposed in Arkansas, Illinois, Iowa, Maryland, Massachusetts, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Washington, and Wisconsin. There also are federal proposals on the table that could affect CME. For a Web exclusive article on these, click here.
For more articles on regulatory issues, click here.