In this subtitle the following words have the meanings indicated. “Essential off–patent or generic drug” means any prescription drug: For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired; That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or That has been designated by the Secretary as 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; That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and That is made available for sale in the State. “Essential off–patent or generic drug” includes any drug–device combination product used for the delivery of a drug for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired. “Price gouging” means an unconscionable increase in the price of a prescription drug. “State health plan” has the meaning stated in § 2–601 of this title. “State health program” has the meaning stated in § 2–601 of this title. “Unconscionable increase” means an increase in the price of a prescription drug that: 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 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: The importance of the drug to their health; and Insufficient competition in the market for the drug. “Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.

A manufacturer or wholesale distributor may not engage in price gouging in the sale of an essential off–patent or generic drug. It is not a violation of subsection (a) of this section for a wholesale distributor to increase the price of an essential off–patent or generic drug if the price increase is directly attributable to additional costs for the drug imposed on the wholesale distributor by the manufacturer of the drug.

The Maryland Medical Assistance Program may notify the Attorney General of any increase in the price of an essential off–patent or generic drug when: The price increase, by itself or in combination with other price increases: Would result in an increase of 50% or more in the wholesale acquisition cost of the drug within the preceding 1–year period; or Would result in an increase of 50% or more in the price paid by the Maryland Medical Assistance Program for the drug within the preceding 1–year period; and 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; 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 If the drug is made available to consumers only in quantities that do not correspond to a 30–day supply, a full course of treatment, or 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. On request of the Attorney General, the manufacturer of an essential off–patent or generic drug identified in a notice under subsection (a) of this section, within 45 days after the request, shall submit a statement to the Attorney General: 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 any increase in the price of the drug within the 1–year period preceding the date of the price increase; 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 Providing any other information that the manufacturer believes to be relevant to a determination of whether a violation of this subtitle has occurred. The Attorney General may require a manufacturer or a wholesale distributor to produce any records or other documents that may be relevant to a determination of whether a violation of this subtitle has occurred. On petition of the Attorney General and subject to subsection (e) of this section, a circuit court may issue an order: Compelling a manufacturer or a wholesale distributor: To provide the statement required under subsection (b) of this section; and To produce specific records or other documents requested by the Attorney General under subsection (c) of this section that may be relevant to a determination of whether a violation of this subtitle has occurred; Restraining or enjoining a violation of this subtitle; Restoring to any consumer, including a third party payor, any money acquired as a result of a price increase that violates this subtitle; Requiring a manufacturer that has engaged in price gouging in the sale of an essential off–patent or generic drug to make the drug available to participants in any State health plan or State health program for a period of up to 1 year at the price at which the drug was made available to participants in the State health plan or State health program immediately prior to the manufacturer’s violation of this subtitle; and Imposing a civil penalty of up to $10,000 for each violation of this subtitle. The Attorney General may not bring an action for a remedy under subsection (d)(2) through (5) of this section unless the Attorney General has provided the manufacturer or wholesale distributor an opportunity to meet with the Attorney General to offer a justification for the increase in the price of the essential off–patent or generic drug. Any information provided by a manufacturer or a wholesale distributor to the Attorney General under subsections (b) and (c) of this section shall be considered confidential commercial information for purposes of § 4–335 of the General Provisions Article unless the confidentiality of the information is waived by the manufacturer or wholesale distributor. In any action brought by the Attorney General under subsection (d) of this section, a person who is alleged to have violated a requirement of this subtitle may not assert as a defense that the person did not deal directly with a consumer residing in the State.