Trump wants the FDA to move faster. His actions are having the opposite effect.

Julia Belluz · Friday, February 10, 2017, 10:02 am

“It doesn’t help if there’s chaos, demoralization, and demonization of the agency.”

A presidential transition is an inherently uncertain time to be a federal employee. New leaders must be appointed. Potential budget and staff cuts loom menacingly. There’s a lot of flux.

But it’s increasingly clear that President Donald Trump’s takeover of the federal government is smashing the norms of transition right and left.

Look no further than what’s happening at the Food and Drug Administration. The agency has become the perfect encapsulation of a transition gone awry.

The confusion now engulfing the FDA can be traced back to the end of January, when President Trump instituted a hiring freeze for the federal government (a change that’s typical of new presidents). Days later, in a more disruptive move, he issued an executive order requiring two regulations to be cut each time a new one is introduced. Both of these orders came with sparse details on how, exactly, they’d be implemented.

Vox reached out to the FDA as well as the Trump team for comment, which deferred to the OMB, and the OMB to HHS. Each agency said they couldn’t clarify anything at this time.

There are also questions about who will become the FDA’s commissioner, whether its thousands of vacancies will be filled, and what the Trump administration’s calls to weaken it mean. The FDA, which makes sure our food and drugs are safe, has many, many regulations — and Trump has vowed to cut 75 to 80 percent of them. “Instead of it being 9,000 pages, it’ll be 100 pages,” Trump told a group of pharmaceutical company executives, presumably in reference to FDA’s guidance and rules.

Former FDA officials, health industry insiders, and experts who study governance and bureaucracies said this has led to an unprecedented degree of uncertainty — which is being felt at federal agencies across Washington. At a time when Trump wants to streamline the government, and speed up regulation, he’s instead bogging it down.

“There’s uncertainty about who the commissioner [at FDA] is. There’s uncertainty about the hiring freeze. There’s uncertainty about the impact of the new regulations policy,” said Josh Sharfstein, an associate dean at the Johns Hopkins School of Public Health and former deputy commissioner of the FDA.

“Having uncertainty on three fronts at once is especially difficult,” and, he added, can be distracting for bureaucrats. “People spend time worrying instead of doing their work, they spend time planning for different contingencies that may never happen.”

The hiring freeze will slow down Trump’s promise to speed up drug administration

Trump and his advisers have made it clear that they want to see big reforms at the nation’s food and drug regulator. They’ve suggested that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market, and they’ve called for deregulation to spur drug approvals and innovation.

But that’s pretty hard to do when you have a hiring freeze. “The only credible way to speed up the review process is to add additional personnel,” said David Kessler, a former FDA head. “If you’re serious about reducing drug review times, you are going to make sure the agency can hire the people.” Instead, limiting the ability to add staff or whittling down staff may have the opposite of the desired effect.

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http://www.vox.com/science-and-health/2017/2/10/14550740/trump-fda