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One Size Still Does Not Fit All

February 3, 2017

In his inaugural address, President Trump issued broad goals of a more prosperous and safer America. The President has had a busy couple of weeks as he works to implement his vision.

At a broad level, he directed OMB and OPM to implement a government-wide federal hiring freeze and he insisted that federal regulations be cut 70% to 80% by eliminating two regulations for every new one proposed. There is now speculation that a major reduction in government-wide discretionary spending is coming. At a broad level, he clearly sees a smaller and less regulatory government as the key to improving people’s lives.

Related specifically to FDA, in a meeting with pharmaceutical executives earlier this week, he stated his intentions to dramatically transform FDA through reduced regulation. He stated his unhappiness with how long it takes to get a pharmaceutical drug approved. He stated that he is looking for a Commissioner who will “streamline” the agency.

For the FDA stakeholder community, less money, fewer people, and fewer regulatory communications (in an agency that promotes and protects the public health through regulation and guidance) feels threatening to FDA’s mission. In light of this, the Alliance and its members are going to need to step up and engage in an unprecedented education campaign on how the FDA works, and why strengthening the agency is actually going to achieve the President’s objectives of a more prosperous and safer America.

We need to show that the FDA is a place where a large group of people — every single American — reaps the rewards from a relatively small group of people at the FDA who are working to make sure food is safe and medical products are safe and effective.

FDA’s best interest is for policymakers to consider the merits of FDA specifically and individually, rather than tying the agency to one-size-fits-all approaches, such as usually occurs in continuing resolutions and proposals for across-the-board funding cuts.

At the core of our argument for FDA will be science. FDA is a unique and uniquely important agency whose greatest strength is its capacity to make science-based decisions. How many people, how many regulations and guidances, and how much change are needed should follow from what gives FDA sufficient capacity for science-based decision making. The more we strengthen FDA’s capacity to make and communicate science-based decisions, the safer and more prosperous America will be. With this message, we are also saying that FDA should be evaluated on its own merits, not through one-size-fits-all policies.

So far, we actually see some light in how these broad policies are being implemented. Take as an example the hiring freeze. There was a dark cloud when the broad sweeping hiring freeze pronouncement was made. But then this week we received additional guidance from OMB on exemptions. We expect that more guidance and/or decisions will be provided soon and that there will be continued recognition of the unique importance and special needs of FDA. And we need the stakeholder community’s voices to be heard as OMB and OPM put together a long-term plan for federal workforce reduction. If agencies and situations are considered on their own merits, there is a reasonable chance of a good outcome for FDA.

We are challenged by the new Administration’s pronouncements, but we needn’t be defeated by them. The President wants a better FDA. We need to help educate and work with the Administration as to what is the best path to get there. As FDA’s stakeholder community, we still have the ability to assist in shaping the agency’s future

Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

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