Gottlieb or not, Trump budget threatens FDA says advocacy group

Trump’s pick for the US Food and Drug Administration (FDA) commissioner role, conservative health policy expert Dr. Scott Gottlieb, was welcomed by the pharma industry​ which feared an endorsement for former policy advisor Jim O'Neill could undo years of regulatory safeguards​.

But according to the Alliance for a Stronger FDA – an independent, not-for-profit group committed to ensuring the FDA is sufficiently resourced – it is the allocation of resources which poses the biggest threat to the Agency under the new administration, and not whoever replaces outgoing commissioner Robert Califf.

“All along, the largest threat to the FDA is that a new commissioner—whoever that turned out to be—will not have the resources to carry out the agency’s mission and responsibilities,” ​spokesman from the advocacy group Steven Grossman told in-Pharmatechnologist.com on Monday.

“That drama will start to play out later this week when the Trump Administration unveils the outline of its FY 18 budget request. FDA is very much at risk.”​

Today's budget proposal​

Trump will release his first budget request today. According to a copy of his “Blueprint to make America Great Again”​ (published today by the Washington Post​), he will request $69bn for the Department of Health and Human Services (HHS), a 17.1% decrease on 2017’s funding.

How this will affect the FDA, which is incorporated within the HHS, is not explained, though there are plans to raise over $2bn from medical product user fees (approximately $1bn than in 2017) to cover pre-market review costs.

“To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products,”​ the blueprint says.

“In a constrained budget environment, industries that benefit from approval can and should pay ​for their share.”​

As for the US’ medical research division the National Institutes of Health (NIH), Trump lays out plans to reduce funding by almost 20% on last year to $25.9bn.

UPDATE: The budget proposal is now available via the White House website (here​)