Abstract
As the U.S. Food and Drug Administration moves to implement a 5% budget cut in fiscal year 2013, along with a drop in user fees paid by drug companies, effects on drug review and approval remain unknown.
In this fiscal year, the U.S. Food and Drug Administration (FDA) is dealing with a 5% budget decrease (about $209 million) from fiscal year 2012 spending levels, after sequestration, or automatic budget cuts, kicked in on April 1. On top of that spending cut, sequestration will also cost the agency an $83 million chunk of the “user fees” that are paid to the agency by drug firms to speed drug reviews and that represent a large part of its spending.
Before sequestration went into effect, the White House warned that the FDA “would face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in new drug approvals. The FDA would likely also need to reduce operational support for meeting review performance goals.”
It's too early, however, to tell whether or how drug approvals actually are being affected.
“We're still determining what impact sequestration may have,” was all an agency spokesperson would say.
The American Society of Clinical Oncology (ASCO) was among the outside groups expressing concern about the potential impact on the speed of drug approvals. Sequestration “will seriously undermine the timeliness of reviews of new cancer treatments and thereby hinder the nation's ability to move the many safe, effective, and innovative medicines currently in the review pipeline to patients whose lives may depend on them,” said ASCO President Sandra Swain, MD, FACP, in a prepared statement.
The cuts come at a particularly bad time for cancer research, because so many academics and drug companies are on the cusp of major advances, comments Christopher-Paul Milne, DVM, MPH, JD, director of research at Tufts University's Center for the Study of Drug Development in Boston, MA.
“Right at the point we need to amplify our efforts, all of a sudden things are getting flatlined,” he says. Drugs that would otherwise be fast-tracked will be most affected, he says, if FDA staff are stretched too thin.
However, R. Alta Charo, JD, a professor of law and bioethics at the University of Wisconsin, says it's too soon to predict disaster. “Because the FDA has the ability to move people around, it's very hard to know how they're going to react if you're not on the inside,” says Charo, who served in the office of the FDA Commissioner from 2009 to 2011.
The FDA can still prioritize drug reviews deemed most important to public health, Charo points out, so she thinks cancer drug approvals will be protected from the cuts.
“If I were to hypothesize, I'd hypothesize that cancer drugs are not the ones that are affected,” she adds. “It'll be the me-too drugs.”