A long-dormant regulatory science program first established by the US Congress in 2007 is, for the first time in years, beginning to show signs of activity, indicating that it could soon begin to influence and enhance product safety as its founders intended.
The foundation, known as the Reagan-Udall Foundation, is a non-governmental, independent entity founded in 2007 as part of the Food and Drug Administration Amendments Act (FDAAA).
Its creation came at a time of significant challenges for the US Food and Drug Administration (FDA). A 2007 report by the agency's Science Board found huge, systemic problems at the agency that it said threatened to prevent FDA from accomplishing its mission.
The principal charges against FDA were three in number: Its scientific base was weak and eroding; it had insufficient regulatory capacity or capability to accomplish its mission; and the agency's information technology infrastructure was inadequate to accomplish its mission.
"The nation is at risk if FDA science is at risk," claimed the report, and then-present deficiencies were only likely to grow in response to increasing demands on the agency and increasing resource constraints.
Scientific advancements, in particular, were highlighted as being one source of extraordinary pressure on the agency. "FDA's inability to keep up with scientific advances means that American lives are at risk," the subcommittee wrote. "While the world of drug discovery and development has undergone revolutionary change - shifting from cellular to molecular and gene-based approaches - FDA's evaluation methods have remained largely unchanged over the last half century."
"Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science," continued the subcommittee.
Though that report came out several months after the September 2007 passage of FDAAA, its conclusions were by no means secret to legislators beforehand. A long-running series of problems at the agency had made clear that changes needed to be made, and legislators seemed compelled to act.
Reagan-Udall is aimed squarely at one of the main findings of the report: That the regulatory capabilities of the agency were insufficient for it to accomplish its mission of getting safe and effective drugs to the public.
As explained in April 2012 by National Public Radio, "The idea was that this foundation could do things FDA can't. It would raise money from private sources, fund research in areas where FDA lacks expertise, and organize collaborations involving industry, patient groups and academia."
But congressional concerns regarding the influence of the life sciences industry on the foundation have prevented the organization from getting the funding it needs to effectively operate.
That funding situation seems to be changing, however. Thanks to a series of grants, including $150,000 in 2010 from PhRMA and $1 million from the Bill and Melinda Gates Foundation, and $900,000 from FDA's 2012 budget, the foundation is finally starting to show signs of life.
And that couldn't come soon enough for some. "I see it as really an exciting opportunity and one that we really desperately need to have in place, to have it up and running," FDA Commissioner Margaret Hamburg told NPR last year. "I think that we're already starting to see the benefits that it can offer."
Hamburg noted that one area in particular that could benefit from the Reagan-Udall Foundation is public-private partnerships, which could be useful in funding regulatory science initiatives that are useful to both industry and government entities alike.
Signs of Life
There are other signs of life as well. The foundation has issued a public request for nominations to its steering committee on Innovation in Medical Evidence Development and Surveillance (IMEDS), a public-private partnership related to FDA's Sentinel Initiative that is intended to advance regulatory science and regulatory tools for postmarket reporting tools. The hope is to be able to "facilitate utilization of a robust electronic health care data platform for generating better evidence on regulated products in the post-market settings," FDA explained in the Federal Register posting. Three projects are already underway, it added.
The foundation is seeking seven voting members to staff IMEDS' steering committee, including two members of the pharmaceutical industry. The other five will include an academic, a clinician, a data partner, a patient advocate and a consumer advocate.
In addition, FDA announced that the foundation is holding its annual open public meeting on 23 May 2013 in Washington, DC. That meeting will allow the public to comment on various Reagan-Udall proposals, but few other details were provided in the Federal Register posting.
For now, it seems, the foundation will need to make sure it can secure its own future before it can better support the future of FDA, and new members and more public visibility seem likely to help with the former.
FDA: Annual Public Meeting of Reagan-Udall Foundation
FDA: Request for Steering Committee Nominations for IMEDS
NPR: FDA To Fund Controversial Research FoundationPharmalot: Reagan-Udall Will Be Transparent: Jane Explains