Competing Drugmakers Compete for FDA Warnings

Competing Drugmakers Compete for FDA Warnings

November 9th, 2012 // 1:47 pm @


This may be a case of taking competition to a new low. Late last month, the FDA Office of Prescription Drug Program issued so-called untitled letters to a pair of drugmakers – ONY Pharmaceuticals and Cornerstone Therapeutics – for hyping their competing treatments for neonatal Respiratory Distress Syndrome.

In both cases, the agency cites the pair for the usual violations – omitting risk information and making unsubstantiated superiority claims. ONY did so on its web site and in a video (here is the FDA letter), while Cornerstone ran afoul of regulations in a pitch letter that was purportedly distributed to journalists by the Fleishman-Hillard public relations firm (here is the FDA letter).

The violations underscore the heated rivalry that occurs when dueling drugmakers attempt to push their medications at the expense of competing treatments. This is not new, of course, but this is an instance where the FDA has caught both of them behaving badly at the same time and doing so in the same manner. And it is not all that surprising, given recent events.

As we reported previously, ONY last year filed a lawsuit against Cornerstone Therapeutics and its foreign parent; the publisher of the Journal of Perinatology; and the authors of a study that ran in the journal, because they allegedly ‘cherry picked’ and ‘manipulated’ data in such a way that its product was unfairly disparaged.

At issue was a published study that Curasurf, the Cornerstone drug used to treat neonatal RDS and its parent, Chiesi Farmaceutici, significantly reduced the likelihood of death when compared with Infasurf, which is sold by ONY. Another defendant was the American Academy of Pediatrics, because it dubbed the journal its official organ for its section on perinatal pediatrics.

In arguing its case, ONY charged that Cornerstone and Chiesi Farmaceutici played unfair. The parent sponsored the study, three of the four authors served as Chieisi consultants and the fourth worked for Premier Research Services, which is a Chiesi contractor. Also, two of the four authors served on the journal editorial board.

However, last May, a federal judge disagreed with ONY and ruled that scientific debate should be resolved in a scientific community, not the courtroom, since the study disclosed the criteria used to reach its conclusions and that the audience is a “highly specialized group of readers” that “brings a well-developed understanding of the issues facing biomedical research,” he wrote (back story).

How and where will the rivalry play out next? This remains to be seen, but we look forward to the next installment.

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