It’s been long known that President Donald Trump wanted to enact a federal hiring freeze and allow cuts by attrition, but lawmakers have sent a letter to the White House urging Trump to come clean on what this means for the FDA after a signing a new order to follow through on this pledge.
The signatories (PDF) from across the subcommittees of health, energy and oversight said: “We urge you [Trump] to consider carefully how instituting a federal hiring freeze will affect FDA. We would remind the Administration that FDA is tasked with approving novel drugs and medical devices to improve how we prevent and treat medical conditions, as well as approving generic drugs that provide critical competition to the market and affordable access to medications for families.”
The agency currently has around 1,000 vacancies, much of them at the FDA's Center for Drug Evaluation and Research (CDER), and the letter's authors want to know just how this freeze will hit these roles.
There has also been a hiring push clause embedded in the 21st Century Cures Act (and the $500 million it got from its passage), which is designed to help the FDA speed up its processes, but they also asked whether this would impact recruitment there too, and if so, why.
They said that “hamstringing” the ability of the country’s “most critical public health agency” to take on much-needed staffers “will hamper FDA’s ability to fulfill its mission and meet the performance metrics, including timelines for medical product reviews and approvals, negotiated with industry under the user fee agreements.”
The FDA is currently being run by Acting Commissioner (and former Deputy Commissioner) Dr. Stephen Ostroff, who replaced Dr. Robert Califf after he handed in his resignation on Trump’s inauguration.
Democratic senators have also sent a letter (PDF) to Dr. Ostroff asking the same thing, specifically on how this would hit its ability to approve new meds and medical devices, and how Trump's attrition plan would hit it long-term.
The senators, which include Elizabeth Warren, said: "A hiring freeze at the FDA would conflict with and do significant damage to these bipartisan efforts to fill vacant positions and expand the scientific and technical workforce needed for a robust review of drugs and medical devices. Patients and their families can't freeze the progress of a disease while the FDA waits to fill critical positions.
"Drug and device manufacturers can't freeze their research and development while the new administration imposes its political ideology. Suspending efforts to fill vacant positions, and create new positions required to implement the 21st Century Cures Act and the new user fee agreements will do serious damage to the FDA's capacity to carry out its mission."
Trump is said to have met with a series of tech and VC leaders for the role, and could introduce a new leader and direction for the agency should one of his more radical picks make it into the top seat.
He said during his campaign last year that he wanted to stop hiring new federal employees to reduce the cost of government, while also lowering the level of regulation countrywide.
Speaking today at a roundtable meeting with pharma heads, Trump said: “We’re going to get rid of a tremendous number of regulations. I know you have some problems where you cannot even open up new plants. You can get approval to open the plants and then you can't get approval to make the drug.
“We’re going to be cutting regulations like nobody has ever seen before. And we're going to have tremendous protections for the people, perhaps even more protections for the people. But instead of being 9,000 pages, it can be 100 pages.”
He also said: “We’re going to streamline the FDA. We have a fantastic person that I think I will be naming very soon. We're going to streamline the FDA. You’re going to get your products either approved or not approved but it's going to be a quick process. It’s not going to take 15 years.”