US and UK authorities are monitoring pharmaceutical spending and disclosure in their respective jurisdictions, seeking transparency in the payments pharmaceutical companies make to the healthcare sector.
Payments covered include those made to patient groups. healthcare associations, charities and training providers.
Pfizer’s $60m to DOJ
The US Department of Justice (DOJ) has announced that Pfizer Inc, on behalf of its wholly-owned subsidiary Biohaven Pharmaceutical Holding Company Ltd, has agreed to pay $59,746,277 to resolve allegations that, prior to Pfizer’s acquisition of the company, Biohaven knowingly caused the submission of false claims to Medicare and other federal healthcare programs by paying kickbacks to healthcare providers to induce prescriptions of Biohaven’s drug, Nurtec ODT.
The anti‑kickback statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, TRICARE, and other federal health care programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives.
Paying providers
The DOJ alleged that Pharmaceutical Holding, from March 2020 through September 2022, selected certain healthcare providers to be part of a group to promote its drug Nurtec ODT, a migraine treatment. These providers were given paid speaking opportunities and meals at high-end restaurants with the intent of inducing them to prescribe Nurtec, the DOJ said. The kickbacks ended once Pfizer terminated Biohaven’s Nurtec speaker programs upon its acquisition of the company, the DOJ said.
“The settlement relates to alleged conduct at Biohaven before Pfizer’s acquisition of the company in October 2022 and does not include any admission of liability or wrongdoing,” a Pfizer spokesperson said. “We are pleased to put this legacy matter behind us, so that we can continue to focus on the needs of patients.”
Meanwhile, in the UK, alleged payments by a pharmaceutical company involved the maker of the popular weight-loss drug, Wegovy.
Novo Nordisk rebuked
The Prescription Medicines Code of Practice Authority (PMCPA), the UK’s pharmaceutical watchdog, has reprimanded Wegovy maker Novo Nordisk for failing to correctly disclose dozens of payments over seven years to pharmacy firms, obesity charities, training providers, professional bodies and patient groups.
The Danish drug giant, Europe’s most valuable listed company, systematically misreported, under-reported or did not disclose such funding, and even after admitting to errors and conducting an internal review, it failed to accurately report its spending.
The company has now been formally reprimanded by the PMCPA, which said it had brought the industry into disrepute. Finding 48 breaches of the industry code, the PMCPA said serious compliance failings – committed while Novo Nordisk was already the subject of an audit over prior breaches – “raised questions about the culture of the company and demonstrated poor governance and a lack of care.”
The alleged breaches included £183,000 ($228,700) in undeclared funding to a weight-loss-coaching company that partners with pharmacies and the NHS and sponsorship of webinars provided by a medical training provider and grants to charities and a royal college. A payment of £338,435 ($423.014) to a global obesity center was also incorrectly disclosed.
New investigations
The firm had previously admitted failing to correctly disclose payments, telling the PMCPA in 2023 that it had omitted more than 500 transactions worth £7.8m ($9.75m) to more than 150 organizations between 2020 and 2022.
The new, undisclosed payments came to light after an investigation by academics in the UK and Sweden who cross-referenced transparency disclosures by Novo Nordisk with financial statements and other records from UK healthcare organizations.
The investigation by researchers at Bath and Lund universities, which overlapped with the PMCPA probe, found that even after conducting an internal review and claiming to rectify the issue, Novo Nordisk failed to accurately record further payments totaling £635,000 ($793,070) to 30 organizations.
Previously, allegations in news reports detailed how Novo Nordisk paid experts who went on to promote its drugs in media appearances without always making their financial interests clear.
Sanctions
There is no legal requirement for companies to disclose payments to the healthcare sector, but many subscribe to an industry code that requires them to report through a voluntary scheme called Disclosure UK.
Disclosure UK is an industry-led initiative to deliver a searchable database that shows payments and benefits made by the pharmaceutical industry to doctors, nurses, and other heath professionals and organizations in the UK.
Alleged breaches are assessed by the PMCPA, which can impose sanctions, including a public reprimand or requiring the company to publish a corrective statement. It can also report the company to the Association of the British Pharmaceutical Industry board, which may suspend or expel the firm from the association.
