> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Commissioners’ Suggestions for Martin Makary - URL: https://www.fdaweb.com/commissioners-suggestions-for-martin-makary/ - Published: 2025-01-16T12:00:00.000Z - Updated: 2026-09-14T14:51:09.000Z - Author: David McFarland - Tags: FDA Policy/General, #legacy-id-D5158499 Voicing the belief that FDA commissioner-nominee **Martin Makary** can have a successful tenure at the agency, commissioner **Robert Califf**, former commissioners **Scott Gottlieb** and **Mark McClellan**, and former acting commissioner **Janet Woodcock** used their time on a panel at the 2025 Summit sponsored by the University of California San Francisco-Stanford Center of Excellence in Regulatory Science and Innovation to suggest ways that would help Makary be successful. Califf said any new commissioner would do well to respect the depth of knowledge and understanding that exists in the FDA staff and their desire to make things better. “If you want to promote change,” he declared, “get the staff on board.” Califf also recommended maintaining a focus on evidence, noting that the ability to analyze data is a huge asset at FDA. “Slogans will not fix it,” he said to appreciative chuckles from the audience. Gottlieb said ideas for major reform work best when they come from the Centers. “You can’t always come in with policies and impose them from the top down,” he cautioned. McClellan’s advice was to build on the agency’s science-based opportunities and infrastructure. “FDA has a lot more evidence capacity than it used to have,” he said. Gottlieb added that successful policy changes require time-consuming rulemaking and a pristine administrative record. The same approach also applies to repealing regulations, he added, noting, “There’s always someone to sue you at FDA.” Woodcock urged Makary to take a step back and look at the big picture of significant changes in science and technology when determining how to move forward. “Where are the scientific and legal challenges going and where do you have leverage to put in the changes that you want in the context of that big picture,” she said. Asked what changes can be expected, Gottlied discussed drug competition and an attempt to address the hurdles facing small companies, and Woodcock mentioned variations in the substantial evidence standard for various diseases. Califf bemoaned the fact that the U.S. does not have a system to generate evidence to inform decisions about what drugs work or don’t work. He said there is no better system than civil servants with no financial interest making decisions on approvals. When the discussion moved to ways to improve the agency’s efficiencies and processes and the work of the so-called Department of Government Efficiency (DOGE), Gottlieb said DOGE may end up focusing on the sphere of regulatory reform. McClellan said that while there is a clear intent to lower costs in government, there isn’t much that can be cut in FDA, especially when compared to what could be possible in cuts through the Centers for Medicare and Medicaid Services. He recommended an effort to find regulatory opportunities such as better using post-marketing resources. He also suggested looking at ways to improve the approval process for gene and cell therapies. “We need to do things differently because the present is different than the past,” Woodcock said. “We have to change because things are changing. Seize the day!” Asked about the recent spate of departures from the agency and staff morale, Califf said he is worried about the number of people leaving. While he has said for some time that the agency turnover rate is too low, Califf added, the message from the incoming administration to “pack your bags and preserve your records” has a negative impact. Some of those leaving he said, are a critical reservoir of information, while for some others it was time for them to move on. “If the new people coming in say to the staff, ‘These are our objectives; how can you help?’, they will get a lot of support,” Califf predicted. Gottlieb said that when he was named commissioner, he tried hard to frame his goals in the context of the agency’s mission. He noted that against the advice given to commissioner nominees, he reached out to and met with the Center directors before he was approved to explain to them how he intended to govern and to tell them he needed them to remain in their positions. He also said that it generally is best if new Center directors come from within the organization, because of the level of background and agency culture that is needed in those positions. “If you intend to be a disrupter by bringing in outsiders,” he said, “I think you’ll be doomed to years of inefficiency.” A major issue for Gottlieb is to preserve the staff's flexible working arrangements that have been the norm for 20 years. “If you change those arrangements,” he warned, “there could be a mass exodus.” As the discussion ended on the question of what those outside FDA can do to be supportive, Gottlieb said he expected Makary to be a strong leader who is a rigorous scientist who looks at the data and sometimes sees an alternative view. He said he believes that approach will serve Makary well at FDA. McClellan called for supporters to speak up about the positive things that are happening at FDA and Woodcock called for consolidating gains and looking for opportunities to put them in a positive light. It fell to Califf to urge that there be no political interference in product decisions. He noted that while some people say there should be no politics anywhere in FDA, in fact, the agency’s rulemaking and guidances are political by design. There should be some bright lines of things that are not acceptable, he said, such as political interference in product decisions, and if the bright lines are broken and the community does not respond in force, “it could be horrible.” Califf also called on the nation to find a way to conduct civil discourse on contentious issues without impugning other people.