§ 2-801

339 words·~2 min read·/md/health-general/2-801

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

§2–801.

(a)In this subtitle the following words have the meanings indicated.

(1)“Essential off–patent or generic drug” means any prescription drug:

(i)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;

(ii)1. That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or

2. 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;

(iii)That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and

(iv)That is made available for sale in the State.

(2)“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.

(c)“Price gouging” means an unconscionable increase in the price of a prescription drug.

(d)“State health plan” has the meaning stated in § 2–601 of this title.

(e)“State health program” has the meaning stated in § 2–601 of this title.

(f)“Unconscionable increase” means an increase in the price of a prescription drug that:

(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:

(i)The importance of the drug to their health; and

(ii)Insufficient competition in the market for the drug.

(g)“Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.