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Advocacy and the “Iron Triangle” of Deficit Reduction

January 13, 2017

This week, Washington was all about confirmation hearings and repealing the Affordable Care Act. … READ MORE …

Advocacy at a Glance

January 13, 2017

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 …

The Speedy Appointment of a New Commissioner?

January 6, 2017

According to the December 29th issue of the Washington Post, Dr. Califf has not heard from the transition team and it is likely that the new Administration intends to appoint their own FDA commissioner rather than retain him. While this has not been announced and must be considered purely speculative, it would not be unexpected since the last two incoming administrations chose to appoint their own commissioner. If true, the Alliance thanks Commissioner Califf for his service to the agency. His leadership, particularly on the need for additional resources for the agency, have been an essential part of FDA’s recent successes.

If there is going to be a new commissioner, the process is likely to occur over several months. Upon the departure of a commissioner, an “acting” is appointed to run the agency until a new commissioner is confirmed. For example, between Dr. Hamburg’s departure and Dr. Califf’s swearing in, Dr. Ostroff served as the acting commissioner. Since he is currently the deputy commissioner for food and therefore available, it is plausible that he will be asked again to be the acting commissioner.

The timing of the rest of the process depends on when the new Administration announces their candidate and how long the confirmation process takes. For comparison purposes, 8 years ago, at the beginning of the Obama administration, Dr. Hamburg was nominated in mid-March 2009 and sworn in by mid-May. Sixteen years ago at the beginning of the Bush administration, the position was vacant for a number of months and Dr. McClellan didn’t take office until November of 2002.

This time, the expectation is that the incoming Trump Administration will want to appoint a new commissioner quickly, perhaps even this month. Based on the experience 8 years ago, tack on about 2 months for the Senate HELP committee to vet the nominee and hold a confirmation hearing and for a full Senate vote to be held. Faster is always possible, but things also may be slowed by the large number of appointees who need confirmation by the Senate.

The Alliance hopes a new commissioner (assuming there will be one) will be an advocate for meeting the funding and personnel needs of the agency. FDA has a sweeping mandate, but not the resources to fully accomplish it.

Beyond that, the Alliance has one other priority: the speedy appointment of a new commissioner once the position becomes vacant. One can argue about the reasons why it is so, but there is general agreement that FDA does not run as well when it lacks a confirmed commissioner. In particular, an acting commissioner (by the nature of their position) is limited in his or her ability to be a successful advocate for the agency’s resource needs.

To be clear, the Alliance does not promote or endorse specific candidates for FDA commissioner. Our members can do that if they so choose, but it is beyond the scope of our broad coalition. Our position with regard to a new commissioner is solely focused on the rapid confirmation of a new commissioner once a vacancy occurs. The immediate appointment of a new FDA commissioner will provide direction to the agency and its staff, reassurance to the American people, and continuity for the stakeholder community.

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

January 6, 2017

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 …

Time for a Deep Breath Before the New Year Begins

December 16, 2016

For a project I am doing apart from the Alliance, I have been asked to identify key events and activities that will shape FDA in 2017. Some of the items include: how FDA is perceived by the Trump Administration; the potential for food- or drug-related crises to change priorities; the need for a solid base of resources for FDA (funding and personnel); and Congressional consideration of user fee reauthorization (both user fees and whatever else might be added to the legislation).

While the Alliance is concerned with only with one of these — the need for a solid base of resources for FDA — I could probably show how all of these either affect, or are affected by, budget authority (BA) appropriations. However, for this end-of-the year column, I am going to stick with the need for a solid base of resources for FDA.

As to the BA appropriation, FDA will be funded in FY 17 under a continuing resolution at FY 16 levels, at least for the first 7 months of this year (through April 28, 2017). Not only does this place a cap on growth in this fiscal year, but it also brings a level of uncertainty that makes it hard for federal agencies to plan for the entire year. As just one example, agencies like FDA need to be careful with hiring new employees, in case the funding level for the last 5 months of the year is lower than the FY 16 level.

The extra $20 million for Cures activities included in the CR is a welcome supplement, but one that comes with its own stream of new responsibilities that are likely to cost even more to implement than will be appropriated. Nonetheless, we are appreciative of Congress’ recognition that FDA needs additional funds when its mission expands.

Looking ahead, the outlook for the U.S. budget is grim. As projected by CBO, the annual deficit will start increasing dramatically over the next few years as more baby boomers qualify for Social Security and Medicare. Also, as interest rates rise (first increase yesterday by the Federal Reserve, possibly three more increases next year), so too does the amount the federal government pays in interest on the national debt. These, and other factors, will place increased pressure on Congress to reduce discretionary spending. (Note that that is as futile as it is inevitable: eliminating all discretionary spending would do little to offset the coming increases in mandatory spending that result from an aging population.)

The discretionary budget picture is no brighter. Under the budget agreement enacted several years ago, the budget ceiling for non-defense discretionary spending increases by very little each year. This means that growth by some agencies, such as FDA, will need to be paid for by cuts in other non-defense programs. Further, proposed growth in defense spending might come at the expense of non-defense programs.

Turning briefly to the other resource issue — personnel — the agency has nearly 1000 vacancies. Provisions in the recently enacted 21st Century Cures legislation will certainly help with recruiting and filling many of these slots, but there is no single solution to getting these positions filled. The FDA stakeholder community needs to treat this as a critical situation and work with FDA to determine additional solutions.

Potentially, the large number of vacancies also courts disaster for the agency. President-elect Trump has said he will impose a federal hiring freeze once in office. There are exemptions for public health and public safety jobs, but no one can be sure at this point whether all, or only some, of FDA’s open slots will be exempt.

In sum, looking at both budget and personnel at FDA, next year looks to be a challenging one. I am optimistic that our advocacy and education efforts can prevail. To do so, we will need to be even more persuasive about the resource needs of FDA, especially why the agency’s mission and responsibilities need to be fully supported by the new Administration and Congress.

On behalf of the Alliance, wishing you a joyous holiday season and a happy and healthy new year. See you in 2017.

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 16, 2016

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 …

Setting the Advocacy Stage for FY 18 and After

December 9, 2016

Last week’s Analysis and Commentary provided an extensive discussion of the funding available to FDA as part of the 21st Century Cures legislation. … READ MORE …