Drug company executives are allowed to serve on a new Food and Drug Administration (FDA)-related board called the Reagan-Udall Foundation. Reagan-Udall was created as part of a major FDA overhaul signed into law this past September and authorized by Congress under Title VI of the FDA Amendments Act. The foundation is supposed to help improve the drug approval process, but with so many scandals involving defective drugs in recent years, is it wise to give the pharmaceutical industry so much say on the Reagan-Udall board?
Does this just shriek conflict of interest? Well, this new food and drug research foundation, which is affiliated with FDA, brings private companies into a curiously close relationship with regulators like the FDA. Serving as chairman of the Reagan-Udall board is former FDA Commissioner Mark McClellan; executives from drug makers Johnson & Johnson and Genzyme, medical device maker General Electric Company, and the Grocery Manufacturers Association, which includes Hormel Food Corporation and Kellogg Company, were among those picked to lead the Foundation. No government officials are permitted to serve as voting members on the board of Reagan-Udall. For the most part, Reagan-Udall will be funded with private donations.
The Foundation was designed to address a matter of real public concern—the gross inefficiencies in our drug development process—by modernizing the process of drug development and evaluation. Interestingly, the Foundation will address these inefficiencies via collaboration among the FDA, academic research institutions, and industry. Does the notion of collaboration between industry and FDA raises the possibility of a conflict of interest? The Congress has proposed independent oversight of the foundation; however, details have not yet been defined and four Foundation board seats are reserved for industry representatives—industries such as pharmaceutical, device, food, cosmetic, and biotech.
If better collaboration between government, industry, and academics can help fix the problem, then why not embrace this new partnership? Well, what about the Foundation’s composition? Will this sort of internal alliance allow industry to influence regulatory policy?
Over the past decade, new drug approvals have lagged far behind the substantial increases in federal and private sector funding of biomedical research. For instance, drug research and development spending increased 150 percent while the overall number of new drug applications for new molecular entities only increased by seven percent over the same period, even declining in recent years. Bringing a new drug to market costs, on average, over $1B and takes 15 years. Yet, only eight percent of cancer drugs entering Phase I of the process will receive approval. Clearly today’s process is horribly run and leads to an untold loss of lives due to delayed or complete lack of access to new and effective therapies.
But consumer advocates and some lawmakers have criticized the relaxed partnership, stating that allowing companies to fund government-sanctioned research could increase the FDA’s vulnerability to industry clout. They also question how the FDA will be able to objectively review products that incorporate its own research and if this new collaboration will open potential for pressure on the FDA. Under the law creating Reagan-Udall, the board’s first task will be to draft guidelines for how the foundation will operate, including the collection and distribution of funding—the board is tasked with awarding funds to researchers in government, academia, and industry. The board’s first meeting has not yet been scheduled.
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