Maryland first US state to enact anti-generic drug price gauging legislation

Maryland will become the first state in the USA to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers, according to a posting on law firm Hyman, Phelps & McNamara’s FDA Law Blog by David Gibbons and Alan Kirschenbaum.

The Bill was passed by the Maryland General Assembly on April 20, 2017 and, on May 26, Maryland Governor Larry Hogan sent a letterto the Speaker of the House stating that he would allow the bill to become law without his signature.

There are two essential provisions of the Bill. First, it prohibits a generic drug manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.” An essential off-patent or generic drug, for purposes of the Bill, is a prescription drug (1) with no unexpired marketing exclusivity under the Federal Food, Drug, and Cosmetic Act; (2) that either appears on the World Health Organization’s model list of essential medicines or is designated as essential for treating a life-threatening or certain chronic health conditions by the Maryland Secretary of Health and Mental Hygiene; (3) is actively marketed in the USA by three or fewer manufacturers; and (4) is available for sale in Maryland.