> ## 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. # Califf Says He Doesn’t Want to Micro-manage FDA, But ... - URL: https://www.fdaweb.com/califf-says-he-doesnt-want-to-micro-manage-fda-but/ - Published: 2016-04-19T12:00:00.000Z - Updated: 2026-09-14T20:55:42.000Z - Author: David McFarland - Tags: FDA Policy/General, #legacy-id-D5135425 > FDA commissioner **Robert Califf** says he is not looking to micro-manage the agency, and he believes that 95% of what FDA does operationally he should keep a distance. “The Centers are there for a reason and they have really competent experts and they make good decisions,” he said during a briefing before the Alliance for a Stronger FDA 4/19 in Washington, DC. He said there are 16 issues that are at the level where he needs to be involved either because they are difficult problems or they are something in which he has a great personal interest. His top two priorities are foundational and the agency needs to get these right “because they underpin everything else we want to do — the workforce and evidence generation.” > > > > The workforce priority is not just hiring, but the need to retain talent. “We have put in place some systems that most modern businesses have to automate more things to enable us to navigate more quickly through the (human resource) system, and they are beginning to work,” Califf said. He observed that there needs to be more interaction with outsiders. For example, he said that at a recent meeting on next generation sequencing (NGS), someone observed that the NGS experts being hired were from industry and academia, “but six months after being hired they are out of date already. This makes the point that we need to interface effectively with the people we regulate, and getting this right is something that needs to be consensus-developed in the community that we work in.” > > > > Evidence generation is also a top priority, according to Califf. “What we want is a situation where information is bountiful and is directed at answering questions that people need answered, and that we have trusted intermediaries to help people navigate the information,” he told the Alliance. “Today, there are no technological limitations to information and it flows very freely, we just have to figure out how to use it quickly and for the right reasons... I think [Sentinel](http://www.fda.gov/safety/fdassentinelinitiative/ucm2007250.htm?ref=fdaweb.com) is giving us a premonition of what is possible. If you told me seven years ago we could aggregate claims data on a 100 million Americans I would have said it was not possible to do. And at some counts, we are at 190 million that FDA can use to look at drug safety issues. Less well advertised is that as of about 10 months from now you won’t be able to submit data for a new drug or biologic unless you use the same standards that have been endorsed by FDA and industry together. And this is going to be revolutionary for transparency and aggregation of information. Although it is not for everything FDA does, but it is a start.” > > > > Reflecting on the Sentinel system, Califf acknowledged that equally the agency needs a [National Device Evaluation System](https://www.fdaweb.com/paper-outlines-device-evaluation-system-coordinating-committee/), and “it is high priority for me is getting everyone to believe this is critical. We have a lot of issues with devices and where they get on the market and then issues come up about safety, and we don't have good numerators or denominators. And if you consider the fact that there is Sentinel where we know who the patients are, we know the drugs they are on and we know the outcomes. So if we had the device identifiers it would go a long way toward a better system for device safety.” > > > > Califf also recognized the increased funding in the recent budget on advancing the vice president’s Cancer Moonshot initiative. “There is a lot of public pressure to create a center of excellence in oncology, and we are going to do that whether it is part of legislation or not because we are committed to do it,” he said. “For me, it doesn’t stop there because it is part of the professionalism for me as a cardiologist, and I don’t think it is a good idea to have totally independent decisions by CDRH, CDER and CBER about cardiovascular care. I’m not arguing that we ought to change the primary direction of control and it still needs to be where it is. But we need to create mechanisms where people with common interests can work together and think together so that we make better decisions as a whole. And so we are very hopeful this will lead to more efficient and more responsive regulation related to particular diseases.” > > > > Additionally, Califf hinted that he is staying close to the internal discussions on how off-label dissemination policies are being formulated. Recent First Amendment losses in court have caused the agency to rethink its position about truthful and non-misleading information dissemination. He said he sat in a meeting earlier in the day about off-label promotion. “As we talk and think about that we must consider that sources of information about medical products are radically different than they were a few years ago, and it is going to continue to change as people have access to globally acquired and disseminated facts and non-facts that end up on the Internet,” he said.