Johnson & Johnson is optimistic that the “breakthrough” designation granted to two new medications, one for depression and the other for bladder cancer, will help it avoid delays in regulatory approval during the longest government shutdown in U.S. history.
The Food and Drug Administration, one of the agencies affected by the partial closing after President Trump refused to sign any government funding bill that didn’t include $5.7 billion for a wall on the southern U.S. border, previously recognized esketamine and erdafitinib as likely to provide substantial improvement over existing medications under a process designed to speed up the review of such drugs. Esketamine targets depression-sufferers who haven’t been helped by other medications.
The FDA has shown it realizes the importance of the drug for patients “who really haven’t had a new mechanism of action in better than a couple decades now,” CEO Alex Gorsky told the health-products company’s investors on an earnings call Tuesday. So far, executives don’t think the process will be delayed but are monitoring it closely.
“We certainly hope both sides come together to reopen the government and end the partial shutdown,” Gorsky said. Drugmakers with new treatment applications under review by the FDA have been bracing for potential approval delays or postponements of key premarket meetings since the shutdown began.
Such deferrals could undermine the benefits of billions in user fees the pharmaceutical industry has invested in strict review schedules that can determine everything from earnings projections to when to go public or when to sell to another company.
Reviews of esketamine and other new medications are paid for through such fees, which the FDA collects from pharmaceutical companies under the Prescription Drug User Fee Act of 1992. Typically, reviews funded that way continue during a shutdown, said Eric Assaraf, an analyst with Cowen Washington Research Group.
FDA Commissioner Scott Gottlieb said earlier this month the agency would shift funding from certain premarket drug review work to post-market drug safety surveillance.
