119th CONGRESS

1st Session

H. R. 4191

1. Short title
2. Essential medicines list
3. Essential medicines risk assessment
4. U.S. pharmaceutical supply chains mapping
5. Definitions
6. Additional provisions

1. Short title

This Act may be cited as the "Mapping America’s Pharmaceutical Supply Act" or the "MAPS Act".

2. Essential medicines list

(a) In general - The Secretary, in coordination with the heads of other relevant Federal departments and agencies and in consultation with, as appropriate, stakeholders who have relevant expertise, shall update and maintain a list of essential medicines (referred to in this Act as the "Essential Medicines List"), initially developed in response to Executive Order 13944 (85 Fed. Reg. 49929), to include active pharmaceutical ingredients and drugs—

(1) - that are directly related to responding to chemical, biological, radiological, or nuclear threats and incidents covered by the National Response Framework;

(2) - of greatest priority for providing health care and identified as being at high risk of shortage; or

(3) - the shortage of which would have an adverse health outcome on patients with chronic conditions.

(b) Updates to list - The Secretary shall review the Essential Medicines List regularly, on a timeframe that the Secretary determines necessary and appropriate, and not less frequently than every 2 years; and shall update the Essential Medicines List as necessary based on the findings of such review.

(c) Compilation of initial list - The Secretary shall complete the first updates to the Essential Medicines List required pursuant to subsection (a) not later than 180 days after the date of enactment of this Act.

(d) Publication of list - The Secretary shall publish the Essential Medicines List promptly after each update pursuant to subsection (b) or (c).

3. Essential medicines risk assessment

(a) In general - The Secretary, in consultation with the heads of other relevant departments and agencies, shall conduct a comprehensive risk assessment of the supply chains for active pharmaceutical ingredients and drugs included on the Essential Medicines List described in section 2.

(b) Contents of essential medicines risk assessment - At a minimum, the risk assessment under subsection (a) shall identify, to the extent available—

(1) - key starting materials and excipients used in manufacturing the active pharmaceutical ingredients and drugs on the Essential Medicines List;

(2) - the active pharmaceutical ingredients and drugs on the Essential Medicines List that rely on a foreign supplier for more than 50 percent of production;

(3) - the active pharmaceutical ingredients and drugs on the Essential Medicines List that are sourced exclusively or primarily from a single supplier, including drugs manufactured domestically from active pharmaceutical ingredients sourced exclusively or primarily from a single supplier;

(4) - current domestic manufacturing capabilities for active pharmaceutical ingredients and drugs on the Essential Medicines List, including the key starting materials and excipients of such ingredients and drugs, and any cost-effective manufacturing technologies, including advanced manufacturing;

(5) - public health and national security risks, including cybersecurity threats and critical infrastructure designations specific to the supply chains of active pharmaceutical ingredients and drugs included on the Essential Medicines List;

(6) - any deficiencies, lack of authorities, or limitations in policy or process that reduce the ability of the Federal Government to address any identified public health or national security risks related to supply chains for active pharmaceutical ingredients and drugs included on the Essential Medicines List; and

(7) - how the Federal Government will mitigate such national security risks, including through the use of authorities under the Defense Production Act of 1950 (50 U.S.C. 4501 et seq.).

(1) Submission of report - Not later than 180 days after the date of enactment of this Act, and annually thereafter, the Secretary, in consultation with the heads of relevant Federal departments and agencies consulted under subsection (a), shall submit a report with the findings under subsection (b) to the relevant Committees of Congress.

4. U.S. pharmaceutical supply chains mapping

(a) Pharmaceutical supply chain mapping - The Secretary of Health and Human Services (referred to in this section as the "Secretary"), in coordination with the heads of other relevant Federal departments and agencies, shall ensure coordination of efforts of the Department of Health and Human Services, including through public-private partnerships, to—

(1) - map, or otherwise visualize, the supply chains, from manufacturing of key starting materials through manufacturing of finished dosage forms and distribution, of drugs (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) included on the Essential Medicines List under section 2; and

(2) - use data analytics to identify supply chain vulnerabilities that pose a threat to public health or national security, as determined by the Secretary or the heads of other relevant Federal departments and agencies.

(b) Requirements - In carrying out subsection (a), the Secretary shall—

(1) - describe the roles and responsibilities of agencies and offices within the Department of Health and Human Services related to monitoring such supply chains and assessing any related vulnerabilities; and

(2) - facilitate the exchange of information between Federal departments, agencies, and offices, as appropriate and necessary to enable such agencies and offices to carry out roles and responsibilities described in paragraph (1) related to drugs described in subsection (a)(1). Such information should include, at a minimum—

(A) - the location of establishments registered under subsection (b), (c), or (i) of section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) involved in the production of active pharmaceutical ingredients and finished dosage forms of drugs described in subsection (a)(1), and the amount of such ingredients and finished dosage forms produced at each such establishment;

(B) - to the extent available and as appropriate, the location of establishments so registered involved in the production of the key starting materials and excipients needed to produce the active pharmaceutical ingredients and finished dosage forms, and the amount of such materials and excipients produced at each such establishment; and

(C) - any regulatory actions with respect to such drugs or the establishments manufacturing such drugs, including with respect to inspections and related regulatory activities conducted under section 704 of such Act (21 U.S.C. 374), the seizure of such a drug pursuant to section 304 of such Act (21 U.S.C. 334), any recalls of such a drug; inclusion of such a drug on the drug shortage list under section 506E of such Act (21 U.S.C. 356e), or prior reports of a discontinuance or interruption in the production of such a drug under section 506C of such Act (21 U.S.C. 356c).

(c) Report - Not later than 18 months after the date of enactment of this Act, and annually thereafter, the Secretary, in consultation with the heads of agencies with which the Secretary coordinates under subsection (a), shall submit a report to the relevant committees of Congress on—

(1) - the current status of efforts to map and analyze pharmaceutical supply chains, as described in subsection (a);

(2) - activities of the Secretary carried out under this section to coordinate efforts as described in subsection (a), including information sharing between relevant Federal departments, agencies, and offices;

(3) - the roles and responsibilities described in subsection (b)(1), including the identification of any gaps, data limitations, or areas of unnecessary duplication between such roles and responsibilities;

(4) - the extent to which Federal agencies use data analytics to conduct predictive modeling of anticipated drug shortages or risks associated with supply chain vulnerabilities that pose a threat to national security; and

(5) - the extent to which the Secretary has engaged relevant industry in such mapping.

5. Definitions

In this Act:

(1) Advanced manufacturing - The term "advanced manufacturing" has the meaning given the term "advanced and continuous pharmaceutical manufacturing" in section 3016(h) of the 21st Century Cures Act (21 U.S.C. 399h(h)).

(2) Cybersecurity threat - The term "cybersecurity threat" has the meaning given such term in section 2200 of the Homeland Security Act of 2002 (6 U.S.C. 650).

(3) Drug - The term "drug" has the meaning given such term in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).

(4) Secretary - The term "Secretary", except as otherwise specified, means the Secretary of Health and Human Services.

6. Additional provisions

(a) Clarification - The participation of the Secretary in developing and updating the list of essential medicines under section 2 shall be deemed to be full satisfaction of the requirements applicable to such Secretary under section 3 of Executive Order 13944 (85 Fed. Reg. 49929).

(b) Confidential commercial information - The exchange of information among the Secretary and the heads of other relevant Federal departments and agencies for purposes of carrying out sections 3 and 4 shall not be a violation of section 1905 of title 18, United States Code. This section shall not be construed to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), section 552 of title 5, United States Code, or section 1905 of title 18, United States Code.

(c) Cybersecurity measures - The Secretary shall ensure that robust cybersecurity measures are in place to prevent inappropriate access to, or unauthorized disclosure of, the information identified, exchanged, or disclosed under sections 3 and 4.

119-HR4191

MAPS Act