FOIAengine: Requests Show FDA Still Under Pressure
This week, we’re taking a closer look at the numerous Freedom of Information Act requests recently filed with the Food and Drug Administration concerning the problematic India pharmaceutical industry.
As we noted in an article last year (see “Big Questions About India’s Pharma”), the FDA has struggled since the Covid-19 pandemic to ramp up its inspections of India’s huge pharma industry. According to Bloomberg, India has the lion’s share of the world’s “active ingredient” manufacturing plants for generic drugs, which account for 90 percent of the drugs that Americans take.
Pharma is a global growth industry for India – the U.S. accounts for 30 percent of the $42 billion industry’s exports – but it remains a headache for the FDA, and thus an ongoing target of FOIA requests by stock traders and the media.
We’ll break down the FOIA numbers below. First, some background:
In the wake of the pandemic, there was a 79 percent decline in inspections of pharmaceutical manufacturing plants in foreign countries and a 35 percent decline in domestic facilities from 2019 to 2022. When travel restrictions limited in-person inspections overseas, the FDA attempted to conduct oversight by relying on facility inspections conducted by foreign regulators; requesting and reviewing records from manufacturers; and sampling products at the border. “But these efforts could not fully replace an on-site inspection. As a result, FDA faces a backlog,” said Mary Denigan-Macauley, director of health at the U.S. Government Accountability Office (GAO).
The FDA now says it’s set to increase the number of inspections at Indian drug manufacturing units in 2024, according to FDA Country Director (India) Sarah McMullen. She said that, after a lull in unannounced inspections during the pandemic, the FDA conducted more than 200 inspections in 2023 in India. “We are putting every effort into increasing the number of inspections … [and] requesting more drug investigators to be stationed here,” she said. The agency also has begun unannounced inspection pilot programs in India and China.
Nonetheless, during a congressional hearing in February, the FDA came under fire from lawmakers over a backlog in inspections of foreign drug manufacturers; delays in beginning unannounced inspections; and vacancies for foreign inspectors. The hearing of the House Energy and Commerce subcommittee on Oversight and Investigations focused on the frequency and quality of FDA’s foreign drug inspections compared to domestic ones, and challenges to increasing in-person inspections overseas, such as attracting and retaining inspection personnel.
“As long as foreign facilities remain uninspected, they pose a risk to quality and safety of life-saving medications that many Americans rely on,” said Rep. Cathy McMorris Rodgers (R-Wash.) chair of the House Energy and Commerce Committee.
Against this backdrop of controversy, investment firms and news media submitted 16 FOIA requests to the Food and Drug Administration during April requesting FDA documents about pharmaceutical manufacturing in India. The FOIA requests reflect continuing concerns about FDA drug supervision efforts in the country. The pharma-related requests were among 974 total FOIA requests made to the FDA during the month.
Eight India-related investment-firm FOIA requests targeted several different manufacturing facilities in India. Zydus Lifesciences Ltd. was the subject of three requests, Alkem Labs was targeted in two requests, and Sun Pharmaceutical Industries Ltd. was targeted in three requests.
Such requests – seeking so-called Form 483 reports and Adverse Event reports – are often made as part of an investment firm’s effort to assess whether FDA inspection and adverse-event reports contain information about a plant’s operations that could affect the company’s stock price. A Form 483 report is issued by FDA inspectors to firms at the conclusion of an inspection that has found indications that a drug has been or may become adulterated or injurious to health. An Adverse Event (FAERS) report describes adverse reactions and medication error reports associated with the use of drug or biologic products.
Following are the India-related FOIA requests filed by investment firms and hedge funds:
- Bank of America Securities submitted requests on April 16 and May 1 for Form 483 inspection reports for Sun Pharma’s Dadra facility in western India that was inspected from December 4 to December 15, 2023. On April 12, Bank of America Securities also submitted a request regarding “Zydus Lifesciences plant inspection at the injectable manufacturing site situated at Jarod, near Vadodara, India.”
- HSBC Securities and Capital Markets (India) Private Limited submitted two requests on April 1 and one request on April 15 for a Form 483 report issued to Alkem Labs for its Baddi, India plant after an FDA inspection in March 2024; a Form 483 report issued to Zydus for a plant in Ahmedabad inspected by the FDA in March 2024; and a Form 483 report issued to Sun Pharma for its facility located at Dadra, India.
- Morgan Stanley submitted a request on April 24 for a Form 483 for Zydus Lifesciences’ April 2024 inspection at Jarod, India.
- Sundaram Mutual Fund submitted on April 25 a request for the Form 483 for the Zydus Lifesciences site located at Jarod, India, which was inspected from April 15 to April 23, 2024.
Major news organizations also were focused on Indian manufacturing facilities during April, with eight requests from the Financial Times, Bloomberg News and CNBC. News organizations targeted several of the same companies that were targeted by the investment firm requesters: Zydus Lifesciences, Alkem Laboratories Limited, and Sun Pharmaceuticals, as well as Eugia Steriles Private Limited.
- The Financial Times on April 1 requested a Form 483 for Alkem Laboratories Limited’s manufacturing facility in Baddi, India, between March 19 and March 27.
- The Financial Times on April 1 requested a Form 483 following the inspection of Zydus Lifesciences Limited’s Injectable manufacturing plant at Ahmedabad, India, between March 18 and March 27.
- The Financial Times on April 9 requested a “Form 483 following inspection at Eugia Steriles Private Limited injectable facility in Parawada Mandal, Anakapalli District, Andhra Pradesh, India between March 28 and April 12.”
- CNBC on Apil 5 requested a “Form 483 for Cipla’s Patalganga (Maharashtra) plant.”
- CNBC on April 24 requested a “Form 483 for Zydus Lifesciences India, Jarod unit, near Vadodara from April 15 to April 23.”
- CNBC TV18 on April 8 requested a “Form 483 for Aurobindo – Eugia Steriles facility and Strides Pharma Chennai Facility.”
- CNBC on April 8 requested a “Form 483 for Alkem Baddi facility.”
- CNBC on April 25 requested a “FORM 483 for Zydus Life’s Vadodara Injectable facility.”
- Bloomberg News on April 12 requested “the FDA form 483 from the agency’s inspection of Sun Pharmaceutical’s Dadra facility that ended December 15, 2023.”
Other Finance Requests
Point72 of submitted 11 requests for a number of drugs and companies, including Ogsiveo, Veozah, Daybue, Syfovre, Izervay, Rezdiffra, Zurzuvae, Eylea, Vabysmo, Xdemvy, and Lonza Biologics. Following are the Point72 FOIA requests broken down by date:
- On April 1 for “FDA FAERS reports on the drug Ogsiveo (nirogacestat), from November 27, 2023 to April 1, 2024 (or the latest date available).”
- On April 3 for “FDA FAERS reports on the drug Veozah (fezolinetant), from 5/1/23 to 4/3/24 (or the latest date available).”
- On April 19 five separate requests for Adverse Event Reports for Daybue, Syfovre, Izervay, Rezdiffra and Zurzuvae.
- On April 22 two separate requests for Adverse Event Reports for Eylea (aflibercept 2mg) and Eylea HD (aflibercept 8mg), and Vabysmo (faricimab).
- On May 1 for “copies of any agency documentation or communication regarding the Form 483 (FEI 3001451441) issued to Lonza Biologics … from February 1 to the present.”
- On April 12 for “records related to up-to-date information on the Adverse Event Reporting related to Xdemvy (Lotilaner .25% produced by Tarsus).”
Deep Track Capital, LP submitted a request on April 2 for “all adverse event reports for OGSIVEO (used to treat desmoid tumors USAN name: nirogacestat), manufactured by SpringWorks Therapeutics, Inc., in Stamford CT from 1/1/2023 through 4/1/2024. Please include results under search term ‘nirogacestat’ prior to FDA approval on 11/27/23, in addition to results under both OGSIVEO and nirogacestat subsequent to 11/27/23.”
English Capital submitted a request on May 1 for “the database of FAERS adverse events reports relating to the drug Daybue (trofinetide) prescription medicine from Jan 1, 2024 to the latest date available at the time of request. Please provide all reports mating the keywords ‘Daybue’ and ‘trofinetide’.”
Krensavage Asset Management LLC submitted a request on April 16 for “483’s issued to LGM Pharma in Boca Raton Florida post inspections of Boca Raton FL and Erlanger KY facilities.”
RBC Capital Markets submitted on April 10 a request “for documents related to Applied Therapeutics’ NDA filing on govorestat (AT-007).”
RBC Capital Markets submitted on April 22 a request stating that “We were hoping to study the review documents that led to recent givinostat approval in DMD. We would love to learn more about your latest views on study endpoints in balance with the drug’s overall efficacy/safety profile. Hope you find this request acceptable.”
RBC Capital Markets submitted a request on May 1 stating: “Hi FDA FOIA Team, Can we please have the detailed case information packets for the following FAERS case IDs? These events occurred with Skyclarys (Omaveloxolone). 23650450 23656134 23646624 23450154 23608335 23472137 23439804 23422732 23250045.”
Vontobel Asset Management submitted on April 15 a request for “FDA corr[espondence] with Zoetis re Librela (Bedinvetmab) on insufficient or new warning labels or any failures in veterinary and clinical support etc.”
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities, and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
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Next from FOIAengine: Hedge fund requests to the Securities and Exchange Commission.
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Learn more about FOIAengine here. Sign up here to become a trial user of FOIAengine.
Write to Randy E. Miller at [email protected].
