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Ensuring and Advocating for an FDA that Works

November 11, 2016

From our start approximately 10 years ago, when former HHS Secretaries from both political parties helped start what eventually became the Alliance, we have always taken a bipartisan approach to our advocacy. The reasoning is simple –- both political parties have an enormous amount at stake to make sure that FDA is well-functioning and fulfills its incredibly important public health mission. Given the enormity of its responsibilities, everyone, regardless of party, wants an FDA that works.

As noted in prior columns, it is inevitable that there will be a lot of change during a transition, whether the same party or a different party wins. At this juncture (right after Election Day), the transition brings so many unknowns at the macro level — personnel, policy, programs, priorities — that it is near-impossible to project the micro changes that might affect FDA and its budget. Nonetheless, we explore three macro issues and possible implications for FDA.

How Will the Trump Administration Handle Personnel? So far, very little is known in terms of personnel decisions. At this point, we do know that two individuals with a high degree of FDA knowledge have been put on the Trump transition team: Andrew Bremberg and Paula Stannard. Both have resumes with deep conservative credentials. Both also have significant understanding of the regulatory work done by FDA, having past experience with reviewing FDA rule-makings at HHS, amongst other responsibilities. Over the next months, more will be made known about who the Trump Administration will put in charge of FDA. We look forward to working with the Trump transition to explain the importance of FDA.

To What Degree Will the New Administration’s Regulatory Reform Platform Extend to FDA? President-elect Trump and his surrogates campaigned against over-regulation, promising to eliminate two regulations for every new one proposed. One of their specific targets was the US Environmental Protection Agency. As a result, it is easy to imagine wholesale changes at EPA: policy decisions reversed, regulations withdrawn, and agency budgets slashed.

During Hill briefings, the Alliance often has to explain why FDA has an entirely differently role than EPA (and for that matter the Securities and Exchange Commission, the Consumer Product Safety Commission, etc.) and how FDA’s actions contribute to growth in the economy. We explain the differences and highlight that FDA is the only federal regulatory agency that has the support of both consumers and industry. The Alliance looks forward to having similar conversations with the transition team and the future Trump Administration officials.

Will Efforts to Slow the Growth of Federal Spending Include a Hiring Freeze? In his Contract with the American Voter, President-elect Trump promised “a hiring freeze on all federal employees to reduce the federal workforce through attrition (exempting military, public safety, and public health).” Unfortunately, a hiring freeze at FDA would have a disproportionately negative impact, as it is trying to fill upwards of a thousand vacancies. If there is a hiring freeze, the Alliance will definitely be at the forefront to make the case that the FDA be allowed to recruit and hire under both the public safety or public health exemptions.

To learn more about the impact of the election on government and politics, I urge you to join the Alliance’s post-election briefing next Tuesday at 1 p.m. To RSVP, contact Lynnette Bechtel.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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