An Act To Increase Consumer Prescription Drug Protections
Sec. 1. 5 MRSA §200-K is enacted to read:
§ 200-K. Consumer protections; prescription drugs
(1) For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, Section 351 of the federal Public Health Service Act and federal patent law have expired;
(2) That appears on the model list of essential medicines most recently adopted by the World Health Organization or that is otherwise an essential medicine due to its efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual's ability to engage in activities of daily living; and
(3) That is made available for sale in the State.
(1) Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health; and
(2) Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of:
(a) The importance of the drug to their health; and
(b) Insufficient competition in the market for the drug.
(1) Three or fewer manufacturers are actively manufacturing and marketing the drug for sale in the United States;
(2) The price increase, by itself or in combination with other price increases:
(a) Would result in an increase of 50% or more in the wholesale acquisition cost of the drug within the preceding 3-year period; or
(b) Would result in an increase of 50% or more in the price paid for the drug within the preceding 3-year period; and
(3) One of the following applies:
(a) A 30-day supply of the maximum recommended dosage of the drug for any indication, according to the label for the drug approved under the Federal Food, Drug, and Cosmetic Act, would cost more than $80 at the drug's wholesale acquisition cost;
(b) A full course of treatment with the drug, according to the label for the drug approved under the Federal Food, Drug, and Cosmetic Act, would cost more than $80 at the drug's wholesale acquisition cost; or
(c) If the drug is made available to consumers only in quantities that do not correspond to a 30-day supply or a full course of treatment or in a single dose, it would cost more than $80 at the drug's wholesale acquisition cost to obtain a 30-day supply or a full course of treatment.
(1) Itemizing the components of the cost of producing the drug and identifying the circumstances and timing of any increase in materials or manufacturing costs that caused the increase in the price of the drug within the 3-year period preceding the date of the price increase;
(2) Identifying the circumstances and timing of any expenditures made by the manufacturer to expand access to the drug and explaining any improvement in public health associated with those expenditures; and
(3) Providing any other information that the manufacturer believes to be relevant to a determination of whether a violation of this section has occurred.
(1) All factors that have contributed to the wholesale acquisition cost increase;
(2) The percentage of the total wholesale acquisition cost increase attributable to each factor; and
(3) An explanation of the role of each factor in contributing to the wholesale acquisition cost increase.
A violation of this section is a violation of the Maine Unfair Trade Practices Act. In any action brought pursuant to this section, the Attorney General has the same authority to investigate and to obtain remedies as if the action were brought under the Maine Unfair Trade Practices Act.
This bill requires the Maine Health Data Organization to annually identify, upon the request of the Attorney General, prescription drugs on which the State spends significant amounts of money and for which the manufacturer's list price for the drug has increased by 50% or more over the past 5 years or 15% or more over the past 12 months. The Maine Health Data Organization is required to provide the list to the Attorney General, who must require the manufacturer of the drugs to provide a justification for the increase.
The bill also prohibits manufacturers and wholesale distributors from price gouging in the sale of essential off-patent or generic drugs. It authorizes the Attorney General to obtain data from the Maine Health Data Organization concerning increases in prices of essential off-patent or generic drugs and requires manufacturers of essential off-patent or generic drugs to submit information to the Attorney General upon request of the Attorney General.