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21st Century Cures Passes House — with Pros and Cons

December 5, 2016

For those returning to their jobs on the Monday after Thanksgiving, there was a surprise. A compromise version of 21st Century Cures legislation had been crafted and was now moving forward through the legislative process. It overwhelmingly passed the House and is expected to pass the Senate next week, despite opposition from some Democratic Senators.

The legislation is nearly 1000 pages long and combines some (but not all) of the original House Cures legislation, along with mental health and opioid legislation and a number of changes to Medicare and Medicaid payment rules. The $6.3 billion legislation is fully paid for by sales of strategic petroleum reserves, transferring money from the ACA’s public health and emergency fund, and a handful of smaller provisions that generate budgetary savings.

The bill creates an FDA Innovation Account to pay for the myriad new activities that will be required of FDA under the 21st Century Cures legislation. Over a 10-year period, the account will receive $500 million, starting with $20 million in FY 17 (the current year) and ending with $55 million in FY 25. Click here to review the allocation by year. The funds will be set aside solely for FDA’s use to carry out Cures-generated responsibilities, and will not count against the budget ceilings that otherwise restrict the growth in non-defense discretionary programs. Nonetheless, the monies will need to be appropriated from the Account; otherwise FDA does not receive the funding. There is no guarantee that the appropriations committees will choose to appropriate these monies or that they will increase the funding available to FDA.

This adds a new dimension to our yearly efforts to increase the budget authority funding available to FDA. The appropriations committees can treat the FDA Innovation Account as additional monies to carry out new responsibilities, which is how they are intended. However, nothing prevents the committees from using these funds to offset an equal number of dollars from the FDA’s BA funding base. In effect, this would require FDA to absorb the entire cost of Cures activities from existing funds and thereby deprive some existing programs of the funding that supports them.

Even with the additional funds, the gap between FDA funding and FDA responsibilities is likely to grow larger with the passage of Cures. The agency will need the Cures funding and more to carry out its mission in both food safety and medical products. As we prepare for the FY 18 appropriation advocacy cycle, which begins in January, it will be even more important that we advocate for increased BA funding and that all FDA stakeholders join in this effort.

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

Advocacy at a Glance

December 5, 2016

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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.

Advocacy at a Glance

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Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA. … READ MORE …

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