FDA seeks FTC action after rejecting petition to block first generics for decades-old vasopressin
The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Last month, Par’s lawyers at Axinn called on the FDA to refrain from approving any generics for Vasostrict due to the potential for certain stability and other specifications that could cause concerns with impurities or other safety issues.
But FDA points out at the top of its response that vasopressin has been marketed as a therapeutic agent for nearly a century.
“Pitressin, a natural vasopressin product developed as an extract of the bovine posterior pituitary, was first introduced in 1928,” the agency said.
What’s more is that Par only won FDA approval for vasopressin in the first place, in 2014, because of the FDA’s drug safety initiative at the time to encourage manufacturers to obtain the agency’s approval for old, unapproved drugs.
In addition to the denying the petition, FDA said that it “does not on its face raise valid scientific or regulatory issues” and “it appears to have been submitted with the primary purpose of delaying approval of Eagle’s ANDA and fails to raise valid scientific or regulatory issues. The Agency intends to refer this matter to the Federal Trade Commission (FTC), which has the administrative tools and the expertise to investigate and address anticompetitive business practices.”
This kind of action from the FDA is rare to see, as lawyer Kurt Karst at Hyman, Phelps & McNamara noted on Twitter, and it may be part of a wider collaboration between the FDA and FTC to put companies on notice over attempts to block future generics.