In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored.

FDA told Baxter in the latest letter that it is “very concerned by your continued violative promotion of your products.” The agency requested that Baxter cease dissemination of the Araplast brochure and respond in writing about how it intends to bring its promotional material in line with the Federal Food, Drug, and Cosmetic Act.

Baxter reports that it has since sent a letter of response to FDA and put its promotional material for Araplast on hold. In a statement issued Aug. 31, the company said it “has confidence in the strength of its promotional review policies and procedures and a history of collaborating with FDA. [Baxter] will continue to work with FDA to ensure the company is in compliance with all relevant rules and regulations.”

The risk of over-production has paid off: world orders for swine vaccines will see billions of dollars in extra revenue for the biggest pharma companies. GlaxoSmithKline, Roche, Sanofi-Aventis, Novartis, and Baxter are all expected to report very healthy first-half earnings as a result of a wealth of government contracts for vaccines and antiviral medicines.

According to a report in the UK Financial Times, GSK has sold 150m doses of its pandemic flu to the UK, US, France and Belgium, and sales of Roche’s Tamiflu have been boosted by orders from the both the public and private sectors. From the US government alone,
Novartis has received an order for $346 million for antigen and $343.8 million for adjuvant, a total sale of nearly $690 million. Total swine flu vaccine sales could ultimately net Novartis between $1 and $1.5 billion.

But, ahead of the publication of the company financial reports, there already seems to be indications of potential backlash about pharma’s return on investment with regard to the swine flu orders. In the UK media, GSK has already been obliged to justify the price of approx. £6 per dose that it has set for its vaccine, with CEO Andrew Witty explaining: “We’ve deliberately been very responsible about pricing — the vaccine is not being sold at a special premium…”

The pandemic has been saturating the UK news much more than in other countries; in the US, it has featured nowhere near as prominently on the agenda. The UK media is notorious for turning against those that it previously championed. One wonders, then, whether this price-based backlash is likely to spiral over the coming months, as the vaccines finally hit the market.

It’s very possible, in the UK at least, that the knights in shining pharma that promised to come to the swine flu rescue just a few weeks ago could be soon be subject to the wrong kind of press attention — once again!