FOIAengine Reveals Requests from a Major Litigant
During May and June of this year, the conservative watchdog group Judicial Watch led the way among non-profit organizations in filing Freedom of Information Act (FOIA) requests to the Food and Drug Administration (FDA). During this period, the organization submitted five requests to the FDA, all on current or potential hot-button issues in Washington.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, 16 non-profit organizations submitted 21 FOIA requests to the FDA during May and June on a wide range of issues, including regulating nicotine products, the abortion drug mifepristone, and Elon Musk’s Neuralink brain implant application.
Judicial Watch’s requests focused on several politically controversial topics: blood donations from those at risk from HIV, the Pfizer and Moderna COVID-19 vaccine applications, drug supply shortages caused by dependence on foreign suppliers, and new approvals for the Abrysvo and Arexvy respiratory virus vaccines.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation, agency action, or future stock price movements.
Judicial Watch describes its mission as promoting “transparency, accountability and integrity in government, politics and the law.” Its website says it fulfills its educational mission through litigation, investigations and public outreach. With a 13-person legal staff and 12 investigators, it brings significant resources to its efforts.
The organization is well known for its use of FOIA requests and lawsuits to investigate claimed misconduct by government officials. Their active use of FOIA requests is reflected in the content of FOIAengine. Over the past three years, Judicial Watch has submitted 244 FOIA requests to at least 15 agencies and departments included in the FOIAengine database. Fifty-two of those requests were made to the FDA.
The conservative group has more than a thousand court cases listed in Docket Alarm and is a fundraising juggernaut. Its most recent IRS report available showed $110 million in annual revenue and $239 million in the bank. For more context on Judicial Watch see our article FOIA Requests Presaged the Post-Roe Fight Over Abortion Rights.
An in-depth article in The New York Times in 2016 reported that “the group has forced the release of government records that would otherwise have been kept from the public.” It went on to say “Judicial Watch’s strategy is simple: Carpet-bomb the federal courts with Freedom of Information Act lawsuits. A vast majority are dismissed…. Critics accuse Judicial Watch of weaponizing the Freedom of Information Act for political purposes.”
While it calls itself nonpartisan, the organization has primarily targeted Democrats since its founding in 1994 by attorney and Republican activist Larry Klayman. According to current president Tom Fitton’s publisher Simon & Schuster, Fitton’s most recent book “explains how the Radical Left and the Deep State destroyed the Trump presidency.”
Following are summaries of three of the controversial issues behind the May and June Judicial Watch requests:
HIV Blood Donor Eligibility: Judicial Watch submitted on May 17 a FOIA request asking for FDA records and communications “regarding assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.” The request asked specifically for “proposed individual risk assessments or risk assessment questions” and the “proposed Donor Health Questionnaire.”
The request relates to a May 11, 2023, FDA update to its guidelines regarding who can donate blood in the United States, eliminating a decades-old rules stemming from the AIDS crisis that prohibited men who have sex with men from donating. The result is new FDA recommendations for assessing blood donor eligibility using a set of individual risk-based questions that will have the effect of permitting certain formerly-HIV positive men to donate blood. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures. The FDA first proposed the changes in January.
Drug Supply Shortages Caused by Foreign Suppliers: Judicial Watch submitted a FOIA request on May 19 asking for records and communications of Emily Thakur, the U.S. Public Health Service team leader on the Drug Shortage Staff, “including emails, email chains, email attachments, text messages, meeting voice recordings, correspondence, statements, letters, memoranda, reports, presentations, notes, or other form of recording regarding … [d]rug supply shortages resulting from raw materials, active pharmaceutical ingredients and/or components from suppliers that originate outside the U.S.”
This request targets another issue that is receiving growing attention in Washington – the increasing U.S. reliance on generic drugs manufactured abroad, which sometimes are in short supply. Generic drugs account for about 90 percent of all prescriptions filled in the U.S., according to the Association for Accessible Medicines, a trade group that represents generic drugmakers. Yet generic drugs represent only about 20 percent of domestic drug spending. Because U.S. drugmakers make less money on generic drugs, production in the U.S. has dwindled, making consumers more dependent on foreign suppliers. For more background on regulatory issues relating to inspections of drug manufacturing facilities in India, see our article on Big Safety Questions About India’s Pharma.
The FDA stated in a June 7 report that it is concerned about the generic drug supply chain and reliance on overseas manufacturing. The FDA said that it “continues to work closely with its colleagues in foreign regulatory authorities and directly with manufacturers to understand what the future impact on supply disruptions might be. FDA is not currently aware of shortages caused by restrictions on exports from Asia or other regions, although the agency continues to monitor for any impact on supplies related to exports.”
The Senate Committee on Homeland Security & Governmental Affairs issued a report last March 20 that found “a continued U.S. overreliance on both foreign and geographically concentrated sources for medications and their raw materials.” The report expressed concerns that shortages of critical medications continue to rise, with the number of active drug shortages in the U.S. reaching a peak of 295 at the end of 2022. It found that nearly 80 percent of manufacturing facilities that produce active pharmaceutical ingredients (APIs)—the key ingredients that give a drug its intended effect—are located outside of the U.S.
Two New Vaccine Approvals: Judicial Watch submitted to the FDA on May 24, 2023, two broad requests for records and communications regarding two new respiratory syncytial virus vaccines (RSV): Abrysvo (manufactured by Pfizer) and Arexvy (manufactured by GSK). The request asked for “[r]ecords and communications of the below-listed U.S. Food and Drug Administration (FDA) persons, including emails, email chains, email attachments, text messages, voice recordings, correspondence, letters, spreadsheets, logs, briefings, meeting minutes, calendar invites, calendar meetings, memoranda, or reports.”
The FOIA request came three weeks after the FDA approved Arexvy on May 3 and about a week before the FDA approved Abrysvo on May 31. Both approvals were for adults ages 60 and above, who are among the most vulnerable to this type of lower respiratory infection. The Centers for Disease Control on June 29 endorsed recommendations from its Advisory Committee on Immunization Practices for both vaccines, which could be available by this fall, ahead of the RSV season.
The vaccine approvals and Judicial Watch FOIA requests come as conservative vaccine opponents ramp up their efforts in opposition to all vaccines, including those for children such as the measles vaccine. Experts also wonder if Americans have so much vaccine fatigue that they will pass up the shot, especially since it is expected to be offered at the same time as the annual influenza vaccine and an updated COVID-19 booster.
RSV protection for infants and children, as referenced in the Judicial Watch request, is the next challenge in the field. Experts believe that one possible avenue is to vaccinate pregnant women. Pfizer is seeking approval for a maternal vaccine meant to prevent RSV in infants from birth to six months by immunizing pregnant women.
Additional non-profit FOIA requests during May and June include:
Physicians Committee for Responsible Medicine submitted to the FDA on June 1 a request for a wide range of documents, communications, and photographs related Neuralink’s brain implant approval application being considered by the FDA. For more perspective on Neuralink, which is owned by Elon Musk, see our article Big Bet on Brain Implants: Elon Musk, Cyborgs, and FOIA.
Functional Government Initiative submitted a request to the FDA on May 3 for “any contracts for consultants or outside experts related to the development of any rulemaking or other agency action on low nicotine products.” This relates to the FDA’s June 21, 2022, news release announcing plans for a proposed rule to establish a maximum level of nicotine in cigarettes with the goal of reducing youth use, addiction and death.
Advancing American Freedom submitted a request to the FDA on May 3 for all communications between any FDA personnel and any other person mentioning abortion drug “mifepristone” and other related terms. Mifepristone was approved by the FDA in September 2000, but has faced new challenges over the past year regarding the FDA’s approval process.
Education for All submitted a request to the FDA on June 15 for a Form 483 Notice of Inspection Observations issued to Baxter Pharmaceuticals relating to a manufacturing facility in Ahmedabad, India.
PETA Foundation submitted a request to the FDA on May 24 for “[a]ny and all records related to PETA’s March 29, 2023 request to investigate Cool Zoo, dba Mister Crabs.” The documents they sought include “inspection reports, citations, agency final decisions of action/inaction, permits/permit applications, photos, videos, and email or other correspondence.” Mister Crabs provides crab race comedy shows for corporate parties, festivals, and school assemblies. People for the Ethical Treatment of Animals (PETA) is the largest animal rights organization in the world, and PETA entities have more than nine million members and supporters globally.
Next: Highlights and lowlights from 803 new FOIA requests filed with the SEC.
Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information companies and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Randy 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 beta user of FOIAengine.
Write to Randy E. Miller at [email protected].
