to use a product derived from animal proteins, Williams says.
“An animal product is intrinsically immunogenic. In this day and age, there’s no reason for it,” Williams says.
ZymoGenetics spent months doing its homework preparing the citizen petition, Williams says, including getting advice from people familiar with the citizen petition process, and former FDA staff. The agency now has 180 days to take some kind of action, although the process can carry on longer than that before the agency makes a decision, he says.
The best case scenario for ZymoGenetics would be a decision by the FDA to pull Thrombin-JMI off the market—which would create a big void that somebody would have to fill. But short of that, ZymoGenetics has asked the FDA to consider a couple of other alternatives. It suggested in the petition that the FDA might want to change Thrombin-JMI’s prescribing information to restrict it for use as a second-choice option after the newer products; set up a strict risk-monitoring program for patients who get the treatment; or warn patients in advance of the risk they are taking with Thrombin-JMI,Williams says.
What are the odds that FDA will pull the King product off the market? As Williams pointed out, a lot of citizen petitions get submitted each year, and some result in a drug getting yanked, but “it’s not the usual outcome.”
When I asked what it says about ZymoGenetics as a company that it’s willing to use such hardball tactics to get more footing in the marketplace, he didn’t directly answer.
“We’re doing this in the interest of patient safety,” Williams says. “Patients are being exposed to a product without a scientific grounding for it. We want to see that there are no more deaths.”
