In FOIAengine, Media Requests Seek the Answer
When word leaked in late August that the Department of Health and Human Services recommended that marijuana should no longer be considered a dangerous drug, media organizations quickly responded with a flurry of Freedom of Information Act requests to the Food and Drug Administration.
The FOIA requests were among many filed by journalists in the past two months relating to drugs and pharmaceuticals, part of a recent overall uptick in FOIA requests from news organizations. Pfizer, Moderna, Abbott Labs, and Novo Nordisk are among the pharmaceutical companies targeted.
Bloomberg, the Associated Press, the New York Times, and the Washington Post are in the latest batch of requests found in FOIAengine, the competitive-intelligence database from PoliScio Analytics that tracks FOIA requests in as close to real-time as their availability allows. We’ll break it all down below, starting with the Biden Administration’s effort to reclassify marijuana. That could have a profound effect on the nascent cannabis industry that’s seeking to go mainstream.
Bloomberg broke the story about the recommendation to put marijuana into the same Schedule III category as drugs like Tylenol.
Currently, marijuana remains classified by the Drug Enforcement Administration as a Schedule I substance, along with drugs such as heroin and LSD. The Schedule I classification is reserved for drugs with a high potential for abuse, no currently accepted medical use in treatment, and a lack of accepted safety for use under medical supervision.
Changing the classification is a stated objective of the Biden Administration – and doing so could give cannabis entrepreneurs a needed boost, providing a tax break and making banking easier.
Reclassifying a drug is a two-step process, and President Biden ostensibly controls the two agencies with responsibility for the decision. The first step in the process is for the FDA or its parent department, HHS, to recommend rescheduling marijuana as a “safe” Schedule III drug. That’s just been done. Now it’s up to DEA to decide whether to implement the recommendation. That review is underway.
But navigating the reclassification could be tricky. The White House has said it’ll be an “independent process. . . . guided by evidence.” As recently as 2015, during the Obama Administration, the FDA explicitly recommended against changing marijuana’s classification.
Before Bloomberg’s August 30 story broke, none of the agencies involved in the decision had made an announcement. The Bloomberg story referenced a letter, from an unnamed official within the Department of Health and Human Services, said to be recommending marijuana’s reclassification as a safe drug. HHS confirmed the letter but didn’t release it. The White House press secretary said she had nothing to add. And the FDA stayed quiet.
FOIA requests became the obvious next step.
CBS News on September 1 asked the FDA for “the memo or equivalent correspondence from the FDA commissioner addressed to the assistant secretary for health describing the recommendation for Controlled Substances Act scheduling of marijuana.”
The New York Times got more specific on September 6, asking for “a document prepared by CDER [the Center for Drug Evaluation and Research] and called ‘Basis for the recommendation to reschedule marijuana into schedule III of the Controlled Substances Act.’”
Bloomberg followed on September 13 with even more details, requesting “a report titled ‘Considerations for Whether Marijuana Has a Currently Accepted Medical Use in the United States for Purposes of Section 202(b) of the Controlled Substances Act,’ which was prepared by the Food and Drug Administration’s Center for Evaluation and Research (CDER), by personnel located in CDER’s Office of the Center Director’s Controlled Substances Staff.”
Neither the DEA nor the FDA has volunteered further guidance, and it’s unclear when or if a decision will be made. In response to questions, a DEA spokesperson told us: “We can confirm DEA received a letter from the Department of Health and Human Services providing its findings and recommendation on marijuana scheduling, pursuant to President Biden’s request for a review. As part of this process, HHS conducted a scientific and medical evaluation for consideration by DEA. DEA has the final authority to schedule or reschedule a drug under the Controlled Substances Act. DEA will now initiate its review.”
Meanwhile, news organizations have been busy with other pharma-related FOIA requests. Weight-loss drugs, and their makers, led the list.
Novo Nordisk: FOIAengine logged at least 11 requests last month from the media about Wegovy, Ozempic, Mounjaro, Rybelsus, and other semaglutide drugs. The principal target of the requests was Novo Nordisk (NYSE: NVO), the high-flying Danish pharmaceutical company behind most of the semaglutides.
News broke on September 19 that an FDA inspection found quality-control lapses at a Novo Nordisk plant in North Carolina that makes Rybelsus. The inspection at the Novo Nordisk plant occurred in mid-July, but hadn’t previously been revealed. Novo Nordisk’s stock took an immediate hit on the September news, but later rebounded to an all-time high.
Reuters, Bloomberg, the Wall Street Journal, and Investor’s Business Daily filed FOIA requests on the same day, September 19, seeking the so-called Form 483 report documenting “objectionable conditions” following an inspection. CBS News and the Washington Post made requests a day later. All were reacting to the initial report by Fierce Pharma. One organization, however, was out in front. Five days before the story hit, the Capitol Forum, which specializes in public-policy investigations for its clients, had Novo Nordisk in its sights, and made a FOIA request for the unfavorable inspection report. (For more about Ozempic and the other semaglutides, see our story, Riding the Ozempic Wave.)
Pfizer: Another noteworthy news media FOIA request focused on Pfizer (NYSE: PFE). That company’s stock has fallen far from its pandemic highs. Adding to its headaches, Pfizer has been under a foreign-bribery investigation by the SEC, but hasn’t said anything beyond terse notices in its quarterly disclosures. (See our story, Foreign Bribery Investigations Loom for Pfizer.)
Pfizer’s most recent notice to shareholders about the ongoing investigation was filed on August 9. Two days later, Bloomberg made multiple FOIA requests to the SEC for “emails, letters, memos, reports and criminal referrals” referencing Pfizer and the three countries – Mexico, Russia, and China – where Pfizer’s payments are the subject of investigation. The SEC denied the requests.
Moderna: It’s been more two years since the FDA green lighted the first mRNA covid vaccines from Pfizer and Moderna (NASDAQ: MRNA), and FOIA requests relating to the approvals continue to roll in. On September 20, Reuters submitted separate FOIA requests relating to each company, referencing requests made earlier by others, including the covid-skeptic Epoch Times.
As to both Pfizer and Moderna, Reuters sought the results of studies of cardiac damage attributable to covid boosters. Completing those studies of subclinical myocarditis and submitting the results to the FDA was a condition of each company’s vaccine’s approval. Pfizer’s report was required by December 30, 2022, and Moderna’s was due by June 30, 2023.
Abbott Labs: We launched FOIAengine earlier this year with a story detailing the numerous FOIA requests that preceded multiple federal investigations into the deadly cronobacter contamination at an Abbott Labs (NYSE: ABT) infant-formula plant. (See FOIA Requests Presaged Huge Problems for Baby-Formula Maker Abbott Labs.) Media interest in the case continues, as a September 12 request from the Associated Press demonstrates. The AP made a sweeping FOIA request to the FDA for “any and all” Abbott- or cronobacter-related documents. The AP’s request replicated one made last year by Brown & Crouppen, a St. Louis plaintiff’s law firm.
Next: What are hedge funds asking about?
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.
Write to John A. Jenkins at JAJ@PoliScio.com.