On July 8, 2011, Governor Paul LePage of Maine signed into law LD 719 titled “An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law” (the Act). The Act repeals three laws obligating manufacturers and labelers of prescription drugs to report drug pricing information, marketing costs, and clinical trials to the Maine Department of Health and Human Services. The Act is effective ninety (90) days following adjournment of the 125th Legislature, First Regular Session, which, in accordance with the Maine Senate website, is Wednesday, September 28, 2011.
The Act repeals Maine's law mandating the reporting of drug pricing information, codified at 22 M.R.S.A. § 2698-B. This statute required prescription drug manufacturers to disclose, on a quarterly basis, the average manufacturer price (AMP) and best price (BP) for all drugs dispensed in Maine that were subject to the Medicaid Drug Rebate Program. Beginning with third quarter 2011, prescription drug manufacturers will no longer be required to submit these price reports to Maine, although manufacturers will continue to be obligated to report AMP and BP to the Centers for Medicare and Medicaid Services (CMS) in accordance federal reporting requirements.
The Act repeals Maine’s marketing cost reporting requirement, codified at 22 M.R.S.A. § 2698-A. Maine’s marketing cost reporting requirement and the regulations promulgated thereunder required manufacturers and labelers of prescription drugs that employed sales representatives in Maine to report, on an annual basis, their costs associated with the advertising, marketing, and direct promotion of prescription drugs in or directed toward Maine, including the aggregate costs of employees and contractors retained to carry out those activities. Except in the case of certain enumerated exceptions, the law also mandated reporting of expenses related to company-sponsored educational and informational sessions and to food, entertainment, travel, and gifts valued at $25 or more. There was a $1,000 annual fee charged to drug manufacturers and labelers that accompanied the annual report.
Clinical Trial Reporting
Lastly, the Act repeals the Maine statute on clinical trial reporting, codified at 22 M.R.S.A. § 2700-A. Maine’s clinical trial reporting statute and the regulations promulgated thereunder required drug manufacturers to register clinical trials on the National Institutes of Health (or other publicly funded) website and to report trial results once available. Drug manufacturers were also required to notify the Maine Department of Health and Human Services in writing of the Internet link or links where their trials were registered and their trial results posted. There was a $1,000 annual fee imposed on each drug manufacturer with products used by Maine residents covered under the MaineCare program (Maine Medicaid program) or the state’s elderly low-cost drug program to support the Maine Department of Health and Human Services’ maintenance of the clinical trial website.
Because the repeal of the Maine laws mandating the reporting of actual prices, marketing costs, and clinical trials will result in a loss of revenue to the state of Maine, the Act also amended 22 M.R.S.A. § 2685 to require each manufacturer of prescription drugs that are provided to Maine residents through the MaineCare program or the elderly low-cost drug program to pay an annual fee of $500 to the state's Department of Health and Human Services to provide funding for such programs.