FOIAengine Reveals Media Pushing FDA for Answers
Journalists made an unusually high number of requests last month to the Food and Drug Administration for information about the safety of India’s pharmaceutical factories, a signal that news organizations are taking note of FDA inspection shortfalls that have led to deaths in the U.S.
According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, the June 2023 Freedom of Information Act requests to the FDA came from numerous media outlets, including Bloomberg, CNBC, and India’s Business Standard, that country’s leading business newspaper. Numerous plaintiffs law firms peppered the FDA with similar requests.
FOIA requests to the federal government can be an important early warning of bad publicity or litigation to come. In this case, the FOIA requests almost certainly presage both. The U.S. deaths and resultant FOIA requests about India’s pharma facilities highlight FDA foreign-inspection inadequacies that investigators from the Government Accountability Office first uncovered last year.
Investigative journalists at ProPublica have also focused on the problems at the FDA, most recently with an April 19 story revealing that the FDA inspected only 3 percent of India’s pharmaceutical manufacturers in 2022 – significantly less than in pre-pandemic 2019, when 45 percent of India’s plants were inspected.
There were other notable media FOIA requests to the FDA in June, including one from the New York Times seeking information about a possible conflict of interest on the part of Dr. Jeffrey Shuren, the head of FDA’s Center for Devices and Radiological Health. We’ll break down those other significant FOIA requests below. But first, we’ll take a closer look at the media requests that illustrate growing concern about the FDA’s drug-safety inspections outside of the U.S.
The problem confronting the FDA is a huge one – because India’s pharmaceutical industry itself is massive. 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 Americans take. (Active ingredients are what make a drug effective against a particular disease or condition.) Of the 100 drugs Americans use most, 83 have no production source in the U.S. for their active ingredients. There are 183 factories in India that make more than 10 active ingredients for the U.S. market. Europe, with 83 such factories, and China, with 35, run a distant second and third. Bringing up the rear is the U.S., with only 19 factories making more than 10 active ingredients for the American market.
India’s government, in its latest Economic Survey, describes its drug industry in reverential terms: the largest provider of generic medicines, producing 20 percent of the world’s supply. It’s a $50 billion-a-year manufacturing industry that exports medicines to over 200 nations.
Given such size and scope, it might seem obvious that the FDA would have robust inspection protocols in place for India’s drug manufacturers, including unannounced inspections (the norm for U.S. plants). But that is not the case – as the GAO declared in its report. In a statement, the FDA blamed the Covid-19 pandemic for the near-total inspection stoppage; the agency recently began a small “pilot” program for unannounced inspections, instead of giving India’s plants advance notice that inspectors will arrive. An agency spokesman said inspections in India have increased in 2023. The GAO continues to express skepticism that the FDA is doing enough. And Congress is taking note. Legislation is pending that would force the FDA to strengthen its foreign-drug-facility inspections. The FDA said it doesn’t comment on proposed legislation.
Bloomberg has done the most comprehensive reporting on India’s pharmaceutical industry, and its journalists and opinion authors have been highly critical of the FDA’s foreign-facility oversight. In an April 4 article entitled, “Just How Dangerous Are India’s Generic Drugs? Very,” Bloomberg Opinion Editor Ruth Pollard wrote that “for a nation that seeks to claim the mantle of ‘pharmacy to the world,’ India is scandalously short on regulatory oversight. In the last six months alone, its generic cough syrups have killed dozens of children, its eye drops have caused blindness, and its chemotherapy drugs have been contaminated.”
The tainted cough syrup killed 70 in Gambia; the chemotherapy drugs were intended for the U.S. market. “The children who died [from tainted cough syrup] – mostly under the age of five years – were given India’s-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts,” Pollard wrote.
As for the eye drops that contained extensively drug-resistant bacteria, “so far, 68 patients across 16 U.S. states have been affected. Three people died, several had to have their eyeballs removed, some went blind.” In the months since Pollard’s article, the toll rose to 81 patients in 18 U.S. states, with four deaths, 14 patients with vision loss, and four cases of eyeballs being surgically removed, according to the latest update from the Centers for Disease Control.
Just one week ago, Bloomberg published what it said would be the first installment of Bad Medicine, “a series about how porous regulation and cheap drugs are endangering lives around the world.” The article recounted the toxic chemicals that were found in the India-produced cough medicine. The cough-syrup incident, the Bloomberg authors wrote, “revealed how poorly the country’s pharmaceutical industry is policed.”
Against this backdrop, FOIA requests about the FDA’s oversight of India’s pharma factories have mounted. Among the 64 news media requests to the agency last month were four from Bloomberg reporters, all focused on that controversy. One June 23 request from Bloomberg sought “the total number of unannounced drug facility inspections conducted in India in 2022 and 2023 so far,” and also asked for a breakdown of how many inspections were classified as “OAI, VAI, or NAI” – agency jargon for “Official Action Indicated,” “Voluntary Action Indicated,” or “No Action Indicated.”
CNBC also weighed in last month with three FOIA requests targeting India’s pharma industry and the FDA’s inspections of various plants there. And reporters at India’s Business Standard, that country’s newspaper equivalent of the Wall Street Journal, filed eight FOIA requests, all seeking detailed information about the FDA’s inspections of food and drug plants in India.
Other noteworthy FOIA requests to the FDA last month included:
- A June 1 New York Times request for “a document that contains a review of Dr. Jeffrey Shuren’s potential conflicts and/or a description of when or how he will recuse himself from decision making related to his wife, Allison Shuren, who co-chairs the Life Sciences and Healthcare Regulatory practice at the firm Arnold & Porter. Please also provide any waivers to the agreement from 8/1/2008 through 5/31/2023.” Shuren is head of FDA’s Center for Devices and Radiological Health, and is often name-checked in FOIA requests. An earlier New York Times request sought similar information about Shuren, but was not as specific. The FDA didn’t identify the reporter making the latest request. As of this writing, the Times hasn’t published anything about Shuren’s potential conflicts. Shuren didn’t respond to a request for comment. An FDA spokesperson, while not addressing Shuren’s situation specifically, responded that the agency, in general, takes all potential conflicts seriously, provides “robust” resources to its employees to ensure the highest possible ethical standards, and “finds its employees consistently comply.”
- A June 2 request from the Wall Street Journal for “copies of and access to any written, electronic, email or other notifications to FDA by Abbott Laboratories regarding any powdered infant formula products contaminated with Cronobacter, Salmonella or any other pathogen from May 1, 2022 to June 1, 2023, including any notifications required by the May 16, 2022 consent decree filed in the Western District of Michigan.” The Journal’s request was identical to an Associated Press request from the previous month, and was one of a number of recent requests – including some from plaintiffs lawyers – targeting Abbott’s tainted baby formula. The FDA didn’t identify either of the reporters making the request. For more background, read our story, “FOIA Requests Presaged Huge Problems for Baby-Formula Maker Abbott Labs.”
- A June 5 request from Abbott Laboratories for inspection reports and warning letters relating to the FDA’s 2019 inspection of a St. Paul, Minn. plant operated by Shanghai-based pharma company WuXi AppTec. WuXi AppTec’s revenues in 2022 were $5.8 billion. We don’t know anything more about this, but it certainly caught our attention.
- Numerous requests from media organizations, including the Wall Street Journal and the Washington Post, for reports of adverse events associated with the semaglutide weight-loss drugs such as Ozempic and Wegovy. For more background, read our story, “Riding the Ozempic Wave.”
Editor’s Note: This story was amended on July 20, adding the FDA’s response to a question about Dr. Jeffrey Shuren.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.