How HR 6607 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes an Office of Drug Manufacturing within the Department of Health and Human Services to increase competition and reduce prescription drug costs.

• 42 U.S.C. 241

  SEC. 310C. MANUFACTURING OF DRUGS.

  This introduces a new section specifically focused on drug manufacturing.

• 42 U.S.C. 241

  (a) Establishment of Office of Drug Manufacturing.--(1) In general.--There is established within the Department of Health and Human Services an office to be known as the Office of Drug Manufacturing (referred to in this section as the `Office').

  This establishes the Office of Drug Manufacturing within the Department of Health and Human Services.

• 42 U.S.C. 241

  (2) Purpose.--The purpose of the Office is--(A) to increase competition, lower prices, and address shortages in the market for prescription drugs, including insulin, asthma and chronic obstructive pulmonary disease (COPD) inhalers, naloxone, epinephrine auto-injectors, and antibiotics;

  This defines the purpose of the Office, focusing on drug competition and addressing market shortages.

• 42 U.S.C. 241

  (B) to reduce the cost of prescription drugs to Federal and State health programs, taxpayers, and consumers;

  This expands the objectives of the Office to include reducing drug costs for health programs and consumers.

• 42 U.S.C. 241

  (C) to increase patient access to affordable drugs and associated devices.

  This aims to improve patient access to affordable medications.

• 42 U.S.C. 241

  (3) Personnel.--(A) Director.--(i) In general.--The Office shall be headed by a Director, who shall be appointed by the President.

  This specifies that the Office will have a Director appointed by the President.

• 42 U.S.C. 241

  (C) Banned individuals.--(i) Drug company lobbyists.--No former registered drug industry lobbyist--(I) may be appointed to the position of Director of the Office; or (II) may be employed by the Office during the 6-year period beginning on the date on which the registered lobbyist terminates its registration in accordance with section 4(d) of the Lobbying Disclosure Act of 1995 (2 U.S.C. 1603(d)) or the agent terminates its status, as applicable.

  This bars former drug industry lobbyists from serving as the Director or being employed by the Office for 6 years after their registration ends.

• 42 U.S.C. 241

  (iv) determine a fair price for each applicable drug, in accordance with subparagraph (B);

  This grants the Office authority to determine fair pricing for drugs it manufactures.

• 42 U.S.C. 241

  (E) Active pharmaceutical ingredients.--(i) In general.--The Office shall manufacture, or enter into contracts with entities to manufacture, an active pharmaceutical ingredient if--(I) the Office determines that such ingredient is not readily available from existing suppliers;

  This allows the Office to manufacture key pharmaceutical ingredients to improve drug availability.

• 42 U.S.C. 241

  (F) Purchase requirements.--Notwithstanding applicable laws relating to the procurement of prescription drugs, the Office shall establish minimum purchase requirements for the Department of Veterans Affairs, the Department of Defense, the Public Health Service, and the Coast Guard to purchase drugs manufactured by or as a result of the Office.

  This mandates that specific federal departments purchase drugs manufactured by the new Office.

• 42 U.S.C. 241

  (7) Reports to congress.--The Director shall prepare and submit to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, an annual report that includes--(A) an assessment of the major problems faced by patients in accessing affordable applicable drugs;

  This requires annual reporting to Congress on drug access issues.