; and (B) because of insufficient competition in the marketplace, consumers cannot reasonably avoid. (6) Qualifying drug The term qualifying drug means any drug, including a combination product whose primary mode of action is determined under section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) to be that of a drug, that— (A) is subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ); and (B) is covered by a Federal health care program. (7) Secretary The term Secretary means the Secretary of Health and Human Services. 3. Price gouging prohibited (a) In general A manufacturer shall not engage in price gouging in the sale of a qualifying drug. (b) Presumption Price gouging shall be presumed if the average manufacturer price has increased— (1) 10 percent or more within the previous 12-month period; (2) 20 percent or more in the previous 36-month period; or (3) 30 percent or more within the previous 60-month period. (c) Notice by Secretary The Secretary shall notify the manufacturer of an increase, within the previous 2 years, in the average manufacturer price of a qualifying drug the Secretary has reason to believe constitutes price gouging, by sending notice to the manufacturer, requesting a statement of justification for the increase, which may include— (1) itemizing the components of the cost of producing the qualifying drug; (2) identifying the circumstances and timing of an increase in materials or manufacturing costs that caused an increase in the average manufacturer price of the qualifying drug within the 5-year period preceding the date of the average manufacturer price increase; (3) identifying the circumstances and timing of any expenditures made by the manufacturer to expand access to the qualifying drug and explaining any improvement in public health associated with those expenditures