Pfizer
From a record criminal fine to the fight over its ATTR-CM franchise
Pfizer is the largest US-headquartered drugmaker by revenue. It is also one of the most litigated. This briefing examines two defining chapters: the 2009 Department of Justice settlement that was then the largest healthcare fraud fine in US history, and the ongoing controversy surrounding tafamidis — its $6.4 billion heart disease franchise — covering pricing, marketing claims, and the patent deals that push generic competition to 2031.
Questions
Why is Pfizer considered one of the most controversial drug companies in the US?
A pattern of recurring controversies — not a single event — defines the company's reputation with regulators, payers, and patient advocates.
Pfizer's reputation has been shaped by a pattern rather than a single event. In 2009 it paid what was then the largest healthcare fraud settlement in Justice Department history — $2.3 billion — over illegal promotion of several medicines. In 2024 it pulled a sickle cell drug from every market after data pointed to excess deaths. And since 2019 its top-selling rare-disease product, tafamidis, has drawn criticism on almost every front at once: its list price, its value for money, its marketing claims, its patient-support arrangements, and the legal deals that have pushed back generic competition.
Q2What was the Bextra scandal and why was the fine so large?
A $2.3 billion settlement — then the largest healthcare fraud fine in US history — over the illegal promotion of an anti-inflammatory painkiller the FDA had already declined to approve for those uses.
Bextra was an anti-inflammatory painkiller. According to NPR's reporting on the settlement, Pfizer asked the FDA to approve Bextra for additional uses, the agency declined over safety concerns, and Pfizer promoted it for those unapproved uses anyway. The drug was voluntarily withdrawn in 2005.
Q3Did the 2009 settlement involve more than just Bextra?
Yes — it covered illegal promotion of Geodon, Zyvox and Lyrica, plus kickback allegations tied to 13 separate products including Lipitor and Viagra.
The same agreement resolved civil allegations about the promotion of the antipsychotic Geodon, the antibiotic Zyvox and the nerve-pain drug Lyrica. Pfizer's own announcement set out roughly $503 million for Bextra, $301 million for Geodon, $98 million for Zyvox and $50 million for Lyrica.
Q4Why did Pfizer withdraw its sickle cell drug Oxbryta?
Clinical data showed the drug's benefit no longer outweighed its risks — including a higher death rate in a paediatric study — triggering an abrupt global withdrawal that disrupted patients with few alternatives.
In September 2024 Pfizer voluntarily withdrew all lots of Oxbryta (voxelotor) worldwide and halted all clinical trials and expanded access programmes. The company said the totality of clinical data showed the drug's benefit no longer outweighed its risks, citing an imbalance in vaso-occlusive (pain) crises and fatal events.
Q5What is tafamidis and why has its price been so heavily criticised?
A $225,000 annual list price at launch made it the most expensive cardiovascular drug on the market. By 2024 the price watchdog ICER concluded it needed an 85–95% discount to meet standard cost-effectiveness thresholds.
Tafamidis, sold as Vyndaqel and Vyndamax, treats transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive heart disease caused by protein deposits in the heart. When approved in 2019, it carried a $225,000 annual list price, making it the most expensive cardiovascular drug on the market. The lead investigator of the pivotal trial, Dr Mathew Maurer, publicly argued the price was not justified.
Q6What are the marketing complaints against Pfizer's Vyndamax?
Pfizer has been accused of describing Vyndamax as "the first and only approved treatment" after rivals were already on the market, and a German court ordered it to stop using "near-complete stabilisation" as a claim.
Critics allege that parts of Pfizer's Vyndamax promotion have been misleading. In September 2025 the company was publicly accused of showing a video at a medical meeting that described Vyndamax as the 'first and only approved treatment' for ATTR-CM - even though BridgeBio's Attruby and Alnylam's Amvuttra were already on the market. A separate Pfizer comparison of two drugs was also accused of not being based on fair and comparable standards.
Q7What are the "pay-for-delay" concerns around Pfizer's tafamidis patents?
Settlements with three generic rivals push US generic entry from around 2028 to June 2031. The terms have not been made public — which is precisely the problem.
From 2023, several generic manufacturers challenged Pfizer's tafamidis patents. Pfizer sued Dexcel, Hikma and Cipla, and then settled with all three in April 2026. BioPharma Dive noted that such 'pay-for-delay' agreements have long drawn scrutiny from federal regulators as tools that can hold back price competition.
Q8How important is tafamidis to Pfizer financially?
The Vyndaqel family generated $6.38 billion in 2025 — roughly 10% of Pfizer's total revenue — making every additional year of exclusivity worth billions of dollars.
Very. Pfizer's full-year 2025 results show the Vyndaqel family (tafamidis) generated $6.38 billion worldwide, up 17% from $5.45 billion in 2024, against total company revenue of $62.6 billion. That makes tafamidis worth roughly 10% of Pfizer's annual revenue.
Q9What should I watch for next with Pfizer?
Four pressure points: patent settlement scrutiny, promotional enforcement, PBM reform, and whether Congress revisits the orphan-drug Medicare exemption.
Four areas. First, whether federal antitrust authorities examine the tafamidis patent settlements that push generic entry to 2031, given long-standing regulatory hostility to pay-for-delay deals. Second, promotional disputes in ATTR-CM - including the matter the National Advertising Division referred to federal agencies - against the backdrop of a wider federal crackdown on drug advertising.