WASHINGTON — A little-known nonprofit established by Congress over 10 years ago to help the Food and Drug Administration work with the private sector is still struggling with a basic question: Where is the cash?
The Reagan-Udall Foundation for the FDA is supposed to act as a liaison between the FDA itself and drug companies, researchers, nonprofits, or other businesses with regulated products who might want to support a project to make the agency’s job easier. It has raised just under $15 million during its first decade, according to the foundation.
That figure pales in comparison to the sums raised by similar congressionally chartered nonprofits that support the Centers for Disease Control and Prevention and the National Institutes of Health, each of which, just last year alone, raised more money than Reagan-Udall has over its entire lifetime. In the past five years, the CDC and NIH foundations together raised about half a billion dollars.
Reagan-Udall’s funding troubles underscore its position in the broader debate about how closely a regulator should work with the industry it regulates — a debate that has shadowed the FDA itself as policymakers consider how much of the agency’s funding should come from taxpayers and how much from drug makers.
And they point, too, to an even more existential question that Reagan-Udall is still grappling with, 10 years in, according to outside observers: What, exactly, is the foundation’s real mission?
“This has always been a foundation that’s struggled to define its purpose in a clear way and, as a consequence, has had difficulty delivering,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest, who served as the FDA’s associate commissioner for public health strategy and analysis from 2014 to 2017. While at the FDA, he supervised the agency’s liaison to Reagan-Udall.
At the same time, the foundation is still struggling to meet the obligations it has set for itself. Information that, according to publicly available, original bylaws, is supposed to be on its website, isn’t there. The results of one of its projects were missing when a STAT reporter checked, and were added later after inquiries.
Reagan-Udall executive director June Wasser defended the organization’s work, saying that individual projects have helped the FDA, drug companies, health care providers, and patients.
At its core, Reagan-Udall is supposed to do work in support of the FDA. In practice, this is a broad mandate, encompassing everything from educating patients to training researchers to building tools for drug companies.
In a sense, it’s similar to the CDC and NIH foundations, both of which take private donations to further scientific research and development, and to promote and protect public health. Both of those organizations are over a decade older than Reagan-Udall.
The Foundation for the NIH focuses on research, forming partnerships between the NIH and private companies, university researchers, and even other government entities like the FDA to do science. Last year, the CDC Foundation helped in the fight against Zika, tracked infectious disease around the world, and put together a website that displayed city-level public health data.
The 2007 law that set up the Reagan-Udall Foundation is both broad and specific, charging Reagan-Udall “to advance the mission” of the FDA, and laying out a variety of ways it can go about doing that — awarding grants, holding meetings, and publishing information.
But the mission has been articulated differently over the years, and it’s not clear how each of the projects are in line with the different versions of the foundation’s purpose.
When then-board chair and former FDA commissioner Dr. Mark McClellan wrote to the PhRMA Foundation in 2010 asking for money, he put it like this, according to current PhRMA Foundation president Eileen Cannon: “Its mission is to assist in the creation of new, applied scientific knowledge needed by the agency to evaluate products, to enhance the FDA’s ability to protect and promote the health of the American public.”
McClellan did not respond to a request for comment.
A spokesperson for Sen. Mike Enzi (R-Wyo.), one of the lawmakers who, along with the late Ted Kennedy (D-Mass.), was responsible for creating the foundation in Congress, said last week that Enzi envisioned the foundation focusing on “assisting in the creation of new, applied scientific knowledge, standards, and tools that the FDA needs to evaluate products more predictably and efficiently.”
Lurie said that these existence of these different ideas about what the foundation should be doing “belies a lack of internal clarity.”
But FDA spokeswoman Amanda Turney told STAT “the Reagan-Udall Foundation was established by Congress to advance regulatory science critical to helping the FDA advance its mission.” She added that the agency “works closely with the Foundation to ensure that its priorities are being addressed.”
So far, one of the foundation’s flagship programs is a computer system called IMEDS, which allows companies to study if their marketed drugs are harming patients. The foundation also helped develop a training course for patients to learn about “big data” so that they can better understand and therefore participate in clinical research. It managed a group that created guidelines for scientists who run tuberculosis drug trials to help them involve more people in the research process. It maintains a database where patients can find information about experimental treatments. It organizes workshops. And it tried to establish a handful of fellowships to allow people to work at FDA — two never started, and one is still in the works.
Wasser said that the foundation’s projects have in fact advanced the mission of the FDA, citing specific examples.
IMEDS, for example, helps the agency and companies determine when products might be harming patients, information that companies must report to the FDA, Wasser said. The tuberculosis guidelines help researchers recruit patients, and the therapies that come out of this research are regulated by agencies like the FDA. And the experimental treatment database “assists FDA to meet its obligations to help sponsors, providers and patients identify and access investigational drugs in life threatening circumstances where no other approved treatments are effective,” Wasser said.
“I suppose one could make an argument that [the programs are] more or less consistent with the mission, to greater or lesser degrees,” Lurie said. “But overall, looking at the bylaws and the totality of what’s been funded, I think the time is ripe for a good look at whether or not the foundation is accomplishing what Congress intended.”
Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, agreed that the foundation’s work is relevant — and suggested more funding might help.
“All of [their programs] sound like they’re reasonable areas of investigation,” he said, adding, “It seems like it’s got an important mission. It seems like it hasn’t been given a lot of resources to pursue that mission.”
“The time is ripe for a good look at whether or not the foundation is accomplishing what Congress intended.”
Dr. Peter Lurie, president of the Center for Science and the Public Interest
Indeed, Reagan-Udall has struggled to corral the resources it might need. At the start, board members thought that industrial sources, such as drug companies and other companies regulated by the FDA, would provide the cash.
“We have struggled to raise money, trying to find a business model,” said Dr. Georges Benjamin, a Reagan-Udall founding board member and the executive director of the American Public Health Association. “Everyone thought that industry would just jump all over this and fund things, and they have not.”
But at the same time, board members were cognizant of the fact that, if they took money from the industry to work on projects that were supposed to help the FDA, it might look like they were being bought by the very companies that the FDA was supposed to be regulating.
“We have been very cautious to say that we can’t be an organization that looks like it is bought and paid for by the people who are regulated by the very agency that we are providing information to,” said Kay Holcombe, board secretary, who used to be the senior vice president for health policy at the drug industry trade group BIO.
Indeed, both the foundations associated with the CDC and NIH have attracted similar controversy.
The NIH foundation has landed in hot water most recently when it was revealed that the beverage industry was exercising too much influence over an industry-funded study on the health impact of alcohol. And in June, a congressional committee also reminded both organizations of their statutory obligation to disclose specific information about their funders. On Thursday, CrossFit and U.S. Right to Know sued them for this information.
As for Reagan-Udall, Wasser declined to release a list of the individual contributions it has received for its projects, but did provide STAT with the total amount of money contributed for each project by either “corporate” or “non-profit” sources. Last year, it published an annual report that listed which organizations supported the foundation’s different initiatives.
Reagan-Udall’s publicly available bylaws require that “the amount of each donation and the identity of the donor, including in kind donations” be available on the foundation’s website. It is currently not available there. Wasser said that the bylaws were changed “a couple of years ago to reflect actual practice and standard language for nonprofits,” and that the provision requiring identifying the amount of each donation was removed.
Lurie and Genevieve Kanter, an assistant professor of medicine, medical ethics, and health policy at the University of Pennsylvania Perelman School of Medicine, said Reagan-Udall should share more information about its donors.
“The public should know the sources of funds to be able to evaluate whether, in light of the projects the foundation is funding, we should be worried about possible distortions in the information,” Kanter said.
The Reagan-Udall Foundation struggled from the start, too, to get its due from the FDA. When the foundation was established in 2007, Congress required the FDA to transfer it between $500,000 and $1.25 million each year. Members of Congress, concerned that a company giving money to the FDA-affiliated foundation while also being regulated by the FDA might create a conflict of interest, blocked the transfer until 2012.
In the meantime, the foundation got by on donated time — Jane Reese-Coulbourne, the first executive director, who is no longer alive, worked for free, said Ellen Sigal, Reagan-Udall’s board chair, who is also the board chair and founder of Friends of Cancer Research. An attorney wrote the bylaws pro bono.
In 2010, it received $150,000 in “seed money” from the PhRMA Foundation, intended for Reese-Coulbourne’s salary, said Cannon.
Two years later, funds started to flow from the FDA. So far, the agency has contributed just shy of $5 million, according to the foundation.
“Those funds all go for just running the operation,” Holcombe said. “None of those funds go for particular projects.”
The FDA declined to specify if the funding it provides is designated for particular projects.
The group has managed to find some funders, pulling together about $15 million through the end of 2017 from pharmaceutical companies, trade groups, other health companies, and nonprofits like the Bill and Melinda Gates Foundation.
“We have raised money,” Sigal said. “I think we’re going slowly, because we are new, we’re a startup, and it takes time.”
Nancy Beck, who worked at Reagan-Udall from 2012 to 2017, said that there just isn’t a huge variety of donors who might want to give money to help improve the regulatory process. And there are lots of organizations who want that money from those same folks.
“There are limits to the number of times you can ask the same organization for funding,” Beck said. “There are also several nonprofit organizations that convene partnership in conjunction with FDA … as well as many advocacy and health research groups, all approaching those same funders.”
The IMEDS program provides perhaps the clearest example of the challenges the agency faces in raising funds to support its work, at least according to one former staff member’s experience.
IMEDS is a computer network that allows a drug company to do research on a vast trove of patient data, such as insurance claims and electronic health records. FDA already has access to this data through a system called Sentinel, so the agency can look for instances of drugs on the market harming patients. IMEDS enables private companies to do similar research.
A few years ago, there were different parts of the IMEDS project. One was focused on research — scientists were developing general tools to analyze the data. These tools would help any company accessing the data, and weren’t specific to a certain company’s needs or request. Other folks were setting up a system to enable companies to run specific studies.
Susan Gruber, who worked at Reagan-Udall in 2014 and 2015 and is now a consultant, worked on the research side. She was on a few fundraising calls for IMEDS.
Gruber said that, based on her experience on the fundraising calls, company representatives were more excited about funding specific projects that might deliver results for their bottom line — rather than general tools that could be used for any project or industry. She eventually left the organization when she said she realized it was unclear where the money for her research would come from.
Currently, IMEDS has been used exclusively by drug companies, some of whom have also given money for the basic research.
Sigal, the foundation’s board chair, said she wants to open it up to researchers and other nonprofits, and that she still wants to do more methodology research.
Kesselheim pointed to IMEDS as an area where Reagan-Udall could be more effective, if it had more money.
“Developing a tool like IMEDS so that it could be used more broadly and by other parties more quickly could be a useful tool, because there are a lot of really important questions about safety of widely used drugs that we need to be asking,” Kesselheim said.
IMEDS has brought in the bulk of Reagan-Udall’s funding — about $12 million of the $15 million in contributions have been earmarked for for the program.
Eli Lilly gave $2 million to help develop IMEDS, said spokesperson Scott MacGregor, and the company also used IMEDS to run a study, which was later submitted to the FDA in relation to one of their products. MacGregor declined to provide information about any other payments Lilly made for IMEDS.
Pfizer has conducted at least two studies with IMEDS, and company spokesperson Jessica Smith declined to say how much it paid.
According to the annual report, Novartis also started working with IMEDS in 2017. Novartis spokesperson Sofina Mirza-Reid confirmed that the company is working with Reagan-Udall, but declined to specify how much, if anything, it had contributed.
Wasser said that the foundation makes public the results of all IMEDS research on its website after the projects are complete. But when she said that, the results of one of the studies, which looked at the relationship between oral contraceptives and blood clots, was not available on the website. After STAT pointed that out, she said that the information been “accidentally taken down.” Now, it is available on the website.
Wasser said that IMEDS fits into Reagan-Udall’s mission and helps the FDA because the agency requires companies to report data on instances when their drugs harm people, and because this data is used by FDA in reviewing drug applications. Companies could find this information using IMEDS.
“Through the use of IMEDS, a wide variety of stakeholders may conduct research that could ultimately lead to advances in patient safety, while maintaining strict privacy protections to ensure data security,” an FDA spokesperson said.
But the FDA has access to the very same data through the Sentinel program. Kanter said that, if IMEDS is a boon for the FDA, it’s an indirect link.
“Is it helping the FDA directly in terms of regulating?” Kanter said. “It’s probably [helping] them indirectly, because it’s helping the companies themselves.”