As noted in prior posts, “Vermont Marketing Disclosure Reports Move from Fiscal Year to Calendar Year” and “Legislators in Maine and Massachusetts Make Noise About Disclosure and Gift Ban Laws,” we continue to see states with aggregate spend disclosure requirements proposing revisions to their existing requirements. Most recently, West Virginia’s Governor’s Office of Health and Lifestyle Planning (“GOHELP”) proposed amendments to Title 210 of West Virginia’s Legislative Rules, entitled “Prescription Drug Advertising Expense Reporting.”
West Virginia currently requires manufacturers and labelers of prescription drugs who employ, direct, or utilize marketing representatives in the state to annually report to GOHELP the “total number of West Virginia prescribers to whom the reporting entity provided, directly or indirectly, gifts, grants or payments of any kind in excess of [$100] for the purpose of advertising prescription drugs.” The proposed amendments to these regulations would, among other things, adjust the reporting threshold from the current $100 to $99.99. Further, the proposed amendments would change the deadline for disclosure and the manner of submission of the disclosure reports. Currently, entities must submit their reports to GOHELP via mail by April 1st. The proposed rule would require disclosure reports to be submitted “electronically by means to be established by GOHELP” by May 1st. Notably, the proposed amendments would also repeal the existing discretionary provisions that permit, but do not require, entities to report free samples of prescription drugs distributed to patients, payments in connection with a bona fide clinical trial, and scholarships and other support for medical students, residents and fellows to attend conferences.
West Virginia’s proposed amendment has been approved by the Legislative Rule Making Review Committee, but must still be approved by the state legislature for final approval.
West Virginia’s proposed amendments reflect the states continued struggle to clarify their role in the face of pending federal disclosure requirements. Here, West Virginia’s repeal of the discretionary provisions may be an effort to remove duplicative disclosures that manufacturers will disclose to the federal government and that will be available to the states and to the general public. With Maine’s repeal of its disclosure statute, Vermont’s modification of its reporting period, and now West Virginia’s effort to repeal its discretionary reporting provisions, we see a trend developing of states amending their disclosure requirements to either rely on the disclosures made by entities to the federal government or to modify their existing disclosure requirements to streamline the reporting process. To date, California, D.C., and Minnesota have been silent about any changes to their disclosure requirements. Are these state just waiting to see the impact of the federal regulations before they make any changes to their existing requirements? Will the trend continue? We can only hope…