FDA Forging Stronger Ties with Gates Foundation in Effort to Support Global Regulatory Excellence

Posted 07 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is working to build greater ties with one of the world's best-funded and preeminent humanitarian organizations, its commissioner announced in a speech last week before the Global Health Product Development Forum.

An 'Exciting Development'

In the speech, Commissioner Margaret Hamburg announced what she referred to as an "exciting development," and certainly one relatively unusual among FDA officials.

Starting 1 May 2013, one of FDA's most senior officials, Murray "Mac" Lumpkin, will serve as a senior fellow of the Gates Foundation, a global health foundation founded by Microsoft co-founder Bill Gates, one of the world's wealthiest individuals.

Lumpkin currently serves as a special advisor to Hamburg, and has recently served as deputy commissioner for international and special programs. But under the new agreement, Lumpkin's expertise will be lent, in part, to the Gates Foundation to help drive a "greater partnership" between FDA and Gates.

"Through a collaboration agreement between FDA and the Gates Foundation, Dr. Lumpkin has been assigned to work with the Gates Foundation to further advance our shared global health goals," FDA spokeswoman Erica Jefferson added in a statement provided to Regulatory Focus.

Lumpkin, Hamburg said, will be working on many of the issues identified in her speech before the Forum, including supporting the development of global regulatory systems, providing assistance to foreign regulatory training programs on good clinical practice inspections and generic drug review requirements, a regional regulatory hub located within the Pan American Health Organization (PAHO), and developing new pharmacovigilance systems in Africa and Asia.

Rationalizing Regulatory by Finding Efficiencies

Lumpkin will also be working on at least one additional initiative along with the Gates Foundation, Hamburg explained. "I know that the Gates Foundation is now focused also on trying to help rationalize the various regulatory processes required to get effective, quality products for neglected diseases to those who need them. Looking at ways the global regulatory enterprise might truly leverage the work and resources of regulatory agencies, various strength-based partnership options are being discussed."

That process of rationalization is set to manifest itself in the form of mutual reliance upon other regulatory bodies. So, for example, if a facility is found to meet current good manufacturing practices by one regulator, other regulators might rely on that same finding to save their resources in order to inspect other, higher-risk facilities.

"The Gates Foundation's early investments in efforts like the African Medicines Regional Harmonization are at the forefront of this frontier field of global health," Hamburg continued. "The FDA has advocated strongly for U.S. government support, especially in the areas of safety surveillance and encouraging other African economic communities to develop and submit their own regulatory rationalization/harmonization plans - such as was done by the EAC."

A Respected Voice for Regulatory

As for Lumpkin, Hamburg said he was a natural fit for the role given his 23 years of expertise at FDA and international background.

"Mac is one of our most senior, expert, respected and accomplished physician scientists and leaders at the FDA," she said. "He has been an enormous catalyst for the repositioning of the FDA to respond to the challenges of globalization, and I think that we are all extremely enthusiastic about this new opportunity for greater partnership with the Gates Foundation."

According to Jefferson, Lumpkin will be working on the regulatory projects with the Gates Foundation for at least two years. The extent of his involvement and whether he will be working on additional projects is still unclear. 

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