CATHY McMORRIS RODGERS, WASHINGTON FRANK PALLONE, JR.

, NEW JERSEY
CHAIR RANKING MEMBER
ONE HUNDRED EIGHTEENTH CONGRESS

Congress of the United States

House of Representatives
COMMITTEE ON ENERGY AND COMMERCE
2125 RAYBURN HOUSE OFFICE BUILDING
WASHINGTON, DC 20515-6115
Majority (202) 225-3641
Minority (202) 225-2927

December 13, 2023

The Honorable Robert M. Califf, M.D., MACC

Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903

Dear Dr. Califf,

Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee is

investigating the Food and Drug Administration’s (FDA) foreign drug inspection program. On
July 18, 2023, the Committee sent you an oversight request letter seeking information and
documents relevant to this ongoing investigation. To date, the FDA has not provided any response
to the Committee. We now reiterate our earlier requests for information and documents in this
letter to expedite our investigation.

Since our first letter to the FDA, it has come to light that the FDA ended its unannounced
foreign inspection program out because the agency believed it was an obstacle to deeper
collaboration with India.1 The same reporting also alleges that the FDA undermined a Department
of Defense initiative to independently test the quality of imported drugs used by the military out
of fear that it would undermine the FDA’s credibility.2 In addition, a newly published study has
confirmed that FDA foreign inspections in 2022 were down 79% compared to 2019 while at the
same time the number of “citations rose dramatically, despite all establishments being given
advance notice of inspections.”3

Since July there have also been additional drug recalls from Indian manufacturers and plant
closures in the United States. In August, Indian drug manufacturers, Alembic and Aurobindo

1
Anna Edney and Riley Griffin, The Pentagon Wants to Root Out Shoddy Drugs. The FDA Is In Its Way,
Bloomberg (Dec. 4, 2023), https://www.bloomberg.com/news/features/2023-12-05/pentagon-is-skeptical-of-cheap-
generic-drugs-approved-by-the-fda.
2
Id.
3
Emily Cuddy, Yun Peng Lu, and David B. Ridley, FDA Global Drug Inspections: Surveillance of Manufacturing
Establishments Remains Well Below Pre-COVID-19 Levels, 42 Health Affairs 12, 1758-1766 (Dec. 2023),
healthaffairs.org/action/showCitFormats?doi=10.1377%2Fhlthaff.2023.00686&mobileUi=0
Letter to The Honorable Robert M. Califf, M.D., MACC
Page 2

Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively.4
Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to
“failed impurities/degradation specifications.”5 Aurobindo recalled rufinamide tablets used to treat
seizure disorders.6 As you are aware, both companies have a history of drug recalls and quality
control failures. Last year, the FDA issued Alembic a Form 483, which cited its manufacturing
plant in Panelav, Gujarat with four observations following a 10-day inspection.7

Meanwhile, domestic production of vital medicines continues to be under stress. In early

August, Pfizer announced it would limit the distribution of injectable drugs manufactured at its
North Carolina plant after the facility suffered damage in the aftermath of a tornado.8 In
September, autoinjector maker Aktiv Pharma Group (“AktiVax, Inc.”) announced the closure of
three manufacturing facilities.9 AktiVax produces autoinjectors to treat life threatening
conditions.10 Just last year, the company was awarded over $45 million to supply a nerve agent
antidote to the Strategic National Stockpile.11 Shortages of cancer drugs appear to have eased
slightly in recent months, but demand continues to outstrip supply.12

In short, drug shortages plague our nation. The U.S. cannot afford additional disruptions to
the drug supply chain that reduce the availability of essential medications and force doctors and
patients to make difficult treatment decisions. Members of this Committee have repeatedly
expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program,
including at two separate hearings this Congress before the Subcommittee on Oversight and
Investigations and the Subcommittee on Health.13

Addressing drug shortages remains a top priority for the Committee. The Committee has a
right to the requested information and documents, which are necessary to carry out its
constitutional oversight responsibilities and to inform pending legislation. Accordingly, to assist

4
Joseph Keenan, Alembic and Aurobindo Issue US Drug Recalls, Citing Quality and Production Issues,
FiercePharma (Aug. 21, 2023), https://www.fiercepharma.com/manufacturing/alembic-aurobindo-pharma-issue-
recalls-citing-quality-and-production-issues.
5
Id.
6
Id.
7
Zoey Becker, Alembic Hit with Form 483, Citing 4 Observations at Panelav Plant in India, FiercePharma (Oct. 20,
2022), https://www.fiercepharma.com/manufacturing/alembic-pharmaceuticals-hit-form-483-noting-four-
observations-panelav-plant.
8
Annika Kim Constantino, Pfizer Limits Distribution of Some Drugs from North Carolina Plant Damaged by
Tornado, CNBC (Aug. 4, 2023), https://www.cnbc.com/2023/08/04/pfizer-limits-distribution-of-some-drugs-from-
nc-plant-damaged-by-tornado.html.
9
Fraiser Kansteiner, Government-Backed Autoinjector Specialist AktiVax Shutters ‘Substantially All of Its
Operations,’ Lays Off 70, FiercePharma (Sept. 5, 2023), https://www.fiercepharma.com/pharma/government-
backed-autoinjector-specialist-aktivax-shutters-substantially-all-its-operations.
10
Aktiv Pharma Group, ARAI Autoinjector, https://aktivpharmagroup.com/rescue-auto-injector.
11
Press Release, Aktiv Pharma Group, ARAI-2PAM BARDA Procurement Award (Oct. 3, 2022),
https://aktivpharmagroup.com/news.
12
Tina Reed, U.S. cancer centers report fewer drug shortages, but crisis continues, Axios (Oct. 6, 2023),
https://www.axios.com/2023/10/06/cancer-drug-shortages-crisis-september.
13
Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains: Hearing
Before the Subcomm. on Oversight & Investigation of the H. Comm. on Energy & Commerce, 118th Cong. (May 11,
2023); Preparing for and Responding to Future Public Health Security Threats: Hearing Before the Subcomm. on
Health of the H. Comm. on Energy & Commerce, 118th Cong. (May 11, 2023).
Letter to The Honorable Robert M. Califf, M.D., MACC
Page 3

the Committee in our oversight, please respond, by January 5, 2023, to the questions put forward
in our July 2023 letter, reiterated here for your convenience:

Foreign Inspections Generally

1. Section 3112(e) of the CARES Act gave the FDA additional authority to require
manufacturers to report certain supply chain information to it. The FDA’s May 9, 2023,
letter to the Committee stated that only 44 percent of facilities are reporting the required
data to the FDA.14 Based on the FDA’s letter, a disproportionate percentage of
noncompliant API and finished dose formula facilities are located outside of the United
States. How many regulatory actions has the FDA enforced against noncompliant foreign
facilities regarding the CARES Act reporting requirements? Provide a list of all foreign
facilities that have been penalized for noncompliance. Include in your response a detailed
description of the action taken by the FDA.

2. The FDA ensures the quality of drugs and other pharmaceutical products through
manufacturers’ compliance with facility registration and Current Good Manufacturing
Practice (CGMP) regulations. The Food and Drug Administration Safety and Innovation
Act (FDASIA, P.L. 112-144) contained several provisions providing the FDA greater
insight into the original sources of excipients, API, and finished dosage products.
Specifically, Section 703 requires that drug manufacturers identify the name and place of
business of all establishments involved in the production of drug excipients, while Section
711 revises CGMP regulations to require oversight over the production of any raw
materials for the manufacture of a drug. The FDA has indicated in its recent requests for
additional authorities over supply chain information that it does not currently have access
to original sources for API and other drug excipients, notwithstanding these and other
provisions providing such authorities.

a. Given its authorities under FDASIA, why does the FDA take the position that it
does not have visibility into where API and drug excipients are sourced?

b. Explain in detail, how the FDA processes information received under Sections 703
and 711. As part of your response, explain how has the data received under Sections
703 and 711 informs FDA’s foreign inspections programs and drug shortage
response efforts?

3. Was the FDA consulted by the Department of Defense regarding its decision to test
independently the quality and safety of generic drugs it purchases? If yes, provide
communications and documents related to the consultation.

4. Has the FDA considered a plan to end preannounced inspections of foreign manufacturing
facilities? If no, explain in detail why not? If yes, provide copies of any such plans.

14
Letter from Hon. Robert Califf, FDA Commissioner, to Hon. Cathy McMorris Rodgers, Hon. Morgan Griffith,
and Hon. Brett Guthrie (May 9, 2023) (on file with Committee).
Letter to The Honorable Robert M. Califf, M.D., MACC
Page 4

5. How many FDA inspectors are currently conducting domestic inspections?

6. How many FDA inspectors are currently conducting foreign inspections? Include in your
response how many of these inspectors are operating in each country.

7. How many positions are currently open for foreign inspections? In your response, please
identify the country where the open position is located and how long the position has been
unfilled.

8. The FDA has noted there is a backlog in conducting foreign inspections. How large is the
backlog and what progress has the FDA made in closing it? Include in your response a
complete list of the foreign facilities in the backlog.

9. In the last 10 years, for each year, what percentage of FDA inspections of foreign facilities
have been preannounced, and what was the lead time given for each preannounced
inspection?

10. In the last 10 years, for each year, what percentage of the FDA’s inspections of U.S.
domestic facilities have been preannounced, and what was the given lead time was given
for each preannounced inspection?

Inspections in India

11. Explain in detail why the FDA ended the unannounced inspection pilot program conducted
in India between 2014 to 2015.

12. Does the FDA plan to reinstate the unannounced inspection program in India? If not,
explain in detail why not.

13. For foreign facilities in India that have received a Warning Letter in the last 10 years,
provide a list of which of these facilities have been inspected in-person, inspected remotely,
or not inspected at all since the Warning Letter was issued.

14. In the last 10 years, how many times has a foreign manufacturer in India been inspected
and had their Warning Letter lifted before the FDA investigator filed a report, allowing the
company to get approval for a drug shortage product or its abbreviated new drug
application (ANDA)? Provide a list of these companies, dates of approval, dates of
inspection, and the product that was approved.

15. As early as November 2022, the FDA was aware of significant, repeated quality control
failures at Intas Pharmaceuticals’ Ahmedabad, India manufacturing facility. At the time,
this facility was one of only five finished product manufacturers supplying the U.S. market
Letter to The Honorable Robert M. Califf, M.D., MACC
Page 5

with chemotherapy drugs carboplatin and cisplatin.15 Intas voluntarily stopped operations
at its Ahmedabad plant in response to quality control failures on June 5, 2023.

During a June 9, 2023, briefing with Congressional staff on cancer drug shortages the FDA
stated that it was not aware of the company’s plans to halt operations at its Ahmedabad,
India, manufacturing facility until after the plant had shut down operations. This lapse in
communication is concerning, as the FDA was ostensibly aware of the ongoing quality
issues at the plant, as well as Intas’ significant U.S. market share for cisplatin and
carboplatin and the disruption a plant closure would cause in the supply of these drugs.

It is important for the Committee to understand exactly how and when the FDA was made
aware of Intas’ plans to halt voluntarily operations at its Ahmedabad facility. Explain in
detail and provide copies of any communications between the FDA and Intas
Pharmaceuticals from January 2023 through June 2023 related to the company’s decision
to halt voluntarily production at the Ahmedabad plant closure.

Inspections in China

16. What is the FDA’s plan to ensure that inspections in China can continue despite the
expanded scope of China’s National Security Law? Provide copies of any analysis or
relevant documentation related to China’s National Security Law and its implications for
FDA’s foreign drug inspection program and drug safety.

17. What actions will the FDA take in response to an inspector being detained, arrested, or
otherwise prevented from completing an inspection of a drug manufacturing facility in
China?

18. Has an FDA inspector ever been detained, arrested, or otherwise prevented from
completing an inspection of a drug manufacturing facility in China? Other countries?

19. Provide copies of all communications between the FDA and the Government of China
regarding in-person inspections of drug manufacturing facilities in China from January
2020 to the present.

20. Does the FDA plan to start an unannounced inspection program in China? If not, explain
in detail why not. If yes, provide copies of any such plans.

21. For facilities in China that have received a Warning Letter in the last 10 years, provide a
list of which of these facilities have been inspected in-person, inspected remotely, or not
inspected at all since the Warning Letter was issued.

22. In the last 10 years, how many times has a foreign manufacturer in China been inspected
and had their Warning Letters lifted before the FDA investigator filed a report, allowing

15
U.S. Food & Drug Admin., Form FDA 483 (09/08): Inspectional Observations of Intas Pharmaceuticals Ltd.
(Dec. 2, 2022), https://www.fda.gov/media/164602/download.
Letter to The Honorable Robert M. Califf, M.D., MACC
Page 6

the company to get approval for a drug shortage product or its ANDA? Provide a list of
these companies, dates of approval, and the product that was approved.

In closing, the Committee is concerned that the Department of Health and Human Services
(HHS), including the FDA, has made a deliberate decision to understaff and under-resource its
ability to respond to oversight requests. Therefore, to carry out our constitutional oversight
responsibilities, the Committee is prepared to issue a subpoena if the FDA does not produce the
requested documents by January 5, 2024. The Committee has a right to obtain these materials to
aid in its legislative activities and to ensure that the Executive Branch is complying with the law.

If you have questions about this correspondence, please contact the Majority Committee
Staff at (202) 225-3641. Thank you for your attention to this request.

Sincerely,

Cathy McMorris Rodgers H. Morgan Griffith

Chair Chair
Committee on Energy and Subcommittee on Oversight and
Commerce Investigations

Brett Guthrie
Chair
Subcommittee on Health

CC: Frank Pallone Jr., Ranking Member, Energy and Commerce Committee
Anna Eshoo, Ranking Member, Subcommittee on Health
Kathy Castor, Ranking Member, Subcommittee on Oversight and Investigations