Amid legal crisis, health care exec sends $1 million to MAGA Inc.

On May 26, the Food and Drug Administration (FDA) sent a letter to QOL Medical, a pharmaceutical company, with some serious allegations. The potential consequences pose an existential threat to the company. In response, QOL Medical’s CEO, Frederick “Derick” Cooper, wrote a $1 million check to MAGA Inc., President Trump’s super PAC.

QOL Medical sells Sucraid, a drug that treats congenital sucrase-isomaltase deficiency (CSID), a rare but serious medical condition. Sucraid is effective at treating CSID but is very expensive. The list price can exceed $12,000 per month or $150,000 per year.

The FDA letter accused QOL Medical of using “false or misleading” advertising to sell more Sucraid. The marketing materials, according to the FDA, encouraged doctors to prescribe Sucraid to “patients suffering with unresolved IBS-like symptoms, including gas, bloating, diarrhea, and/or nausea.”

But Sucraid cannot treat irritable bowel syndrome (IBS) or its symptoms. It can only be used to treat “sucrase deficiency.” Overall, the FDA said, the advertising creates a “misleading impression.” As a result, the FDA informed QOL Medical that it was in violation of the Federal Food, Drug, and Cosmetic Act, which prohibits the misbranding of drugs in advertising.

This letter must have been of particular concern to Cooper. In November 2024, QOL Medical and Cooper agreed to a $47 million settlement with the Department of Justice (DOJ) for using a kickback scheme and aggressive sales tactics to induce doctors to prescribe Sucraid to patients who did not need it. As a result, the DOJ alleged, QOL Medical defrauded federal health systems.

“Let this case be a warning to others that we will aggressively pursue all those, motivated by greed, who try to unlawfully enrich themselves at taxpayers’ expense,” Jodi Cohen, FBI Special Agent in Charge, said in a statement.

In return for the $47 million payment, the Department of Health and Human Services (HHS) agreed not to seek to exclude QOL Medical and Cooper “from Medicare, Medicaid, and other Federal health care programs.” Exclusion from federal health care programs would be a devastating blow to nearly any medical company.

The agreement by HHS, however, was contingent upon QOL Medical and Cooper abiding by the terms of a Corporate Integrity Agreement (CIA), which the parties signed simultaneously with the DOJ settlement. The CIA requires QOL Medical and Cooper to comply “with the statutes, regulations, and written directives” of the FDA. Any material breach of the CIA “constitutes an independent basis for QOL’s exclusion from participation in the Federal health care programs.”

Specifically, under the agreement, any “probable violation of FDA requirements relating to the marketing or sale of Government Reimbursed Products” would be considered a “reportable event.” The letter the FDA sent to QOL Medical unambiguously qualifies as reportable. Ultimately, the Office of the Inspector General of the HHS makes a determination about whether any conduct constitutes a material breach.

In any event, the FDA’s May 26 letter gives QOL Medical 15 working days to respond. On June 8, MAGA Inc. received a $1 million check from Cooper.

This isn’t Cooper’s first donation to MAGA Inc. Cooper also donated $2 million to MAGA Inc. in February 2025 and another $1 million in October 2025. Cooper’s donations to MAGA Inc. in the last two years dwarf all of his previous political donations.

As of now, QOL Medical’s alleged violation appears to still be pending. The FDA has not posted a “close out letter,” which would indicate that the issue has been resolved.

Inside QOL’s fraudulent scheme

QOL Medical and Cooper’s 2024 settlement with the DOJ involved an aggressive marketing scheme to increase Sucraid prescriptions. According to the settlement agreement, starting in 2018, QOL Medical began offering health care providers free Carbon-13 breath test kits for people with common stomach and digestive symptoms, claiming that the test kits could “rule in or rule out” CSID.

But the breath test, which was not FDA-approved, did not actually diagnose CSID. It tested for sucrase activity, and other conditions could cause a positive result. According to the settlement, around 30% of the breath tests provided by QOL Medical came back positive. QOL Medical then used these positive tests to convince doctors to prescribe Sucraid to patients.

Between 2018 and 2022, QOL Medical paid for a laboratory to run more than 75,000 of the breath tests, paying around $105 for each test to be analyzed. QOL Medical also paid for the results to be sent to the health care providers and QOL Medical. While the results delivered to QOL Medical did not contain the names of the patients, they “did contain the name of the health care provider who ordered the test, along with the patient’s age, gender, symptoms, and test result.”

QOL Medical then “disseminated this information to its sales force with instructions to make sales calls for Sucraid” to providers of patients with a positive breath test. The company kept track of whether its sales representatives converted positive test results into new prescriptions for Sucraid. According to a press release, “Cooper was aware of and approved the implementation and continuation of this marketing program.”

According to the settlement, some members of the QOL Medical sales teams made unsupported claims about the test’s ability to diagnose CSID. In 2019, at a national sales training, QOL Medical said in slides reviewed by Cooper that sales representatives should tell providers, “If you have a positive breath test, the patient will not improve unless you treat with Sucraid.”

This was all part of a scheme to charge the government, private insurers, and others thousands of dollars a month for a highly specialized drug many patients did not need. QOL Medical’s conduct “resulted in some patients taking Sucraid even though it wasn’t medically necessary,” California Attorney General Rob Bonta said in a January 2025 press release.

In the settlement, the United States contends that QOL Medical and Cooper “caused the submission of false claims to Medicare, TRICARE, VA, and Medicaid.” These false claims were significant because the “restitution” portion of the settlement was $23.5 million. The remainder of the settlement is a penalty for the fraudulent conduct.

If the Trump administration, however, determined that QOL Medical violated its CIA, the economic consequences could be even more severe.