Gottlieb Signals Depth and Scope of Changes Coming to Drug and Device Approvals in FY 19 Budget Comments

April 20, 2018

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On April 17, 2018, FDA Commissioner Scott Gottlieb appeared before the U.S. House Subcommittee on Agriculture, Rural Development to discuss the Fiscal Year 2019 budget request for FDA. He began by touting the broad achievement in record approvals last year for new molecular entities, generic drugs and medical devices. Faster approvals and a lower regulatory burden were hallmark characteristics of policymaker goals for FDA and the Commissioner’s first year in office delivered. Moreover, he cited progress on policy fronts in tobacco control and in nutrition labeling.

He then talked about the kinds of things that would be possible given the increases in funding that are proposed for FDA in the coming year – a $663 million (13 percent) increase above the year before – totaling $5.8 billion. That represents $190 million in new user fees and $473 million in budget authority.

He outlined a litany of advances that FDA will look to make in the coming year, citing first the development of a new regulatory approach to encouraging development in digital health, represented by FDA’s pre-certification program announced last year and the Digital Health Action Plan.

Other focus areas included investments to bring more manufacturing back to the U.S. to better position our response to emergencies such as flu outbreaks, support for compounding pharmacies, further enhancement of generic drug review and development of treatments for rare pediatric conditions.

It was drug development, however that he emphasized, citing a theme he has emphasized in the past which is to review medical treatments through a platform that would reach across functional silos and to extend experience in review and approval beyond existing boundaries – making it both more transparent and more multi-disciplinary. Given the scale and magnitude of policy change necessary to re-align the agency’s approach, he promised a lot more guidance coming from FDA in 2019.

More guidance documents may not sound like less regulation, but he reiterated that their purpose will be to apply new principles in drug development – forging new approaches for proving safety and efficacy. It will also mean that the guidance documents are drawn up to sharply focus on specific diseases or conditions.

The pace and scope of what Dr. Gottlieb is outlining, and indeed has begun, is one not only to change the way things are done, but the very culture of the agency doing them. With that kind of ambitious agenda, we can expect a lot in the way of communications coming out of FDA along a broad spectrum of fronts in FY2019. Ultimately that has an impact on the makers of medicines in two important ways. First the digestion of multiple guidance documents and assessing how they may change approaches to the development of new drugs. But secondly there is a communications impact as well as FDA shifts to “modernize” the approval process. People will need assurance that new approaches do not affect the previous gold standard for approval and that the safety and efficacy of drugs are still important – a message they will need to hear from both FDA and from drug companies.