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A new charitable foundation that was set up to promote collaboration in research between the US Food and Drug Administration and the drug and medical device industries has sparked concerns that it will undermine the FDA's independence.
The Reagan-Udall Foundation, which will be headed by Mark McClellan, who at one time led the Food and Drug Administration and later the federal Medicare and Medicaid health insurance programmes, was spearheaded by the Democrat senator Ted Kennedy in a bid to reform the FDA.
The foundation's creation should shorten the time it takes to develop new drugs, ultimately reducing the cost to patients, he said.
An initial focus of the foundation is likely to be on the development, standardisation, and validation of biomarkers of drug safety and efficacy.
Companies have in the past been reluctant to share such basic research information with competitors. But they now realise that developing the next generation of biomarkers, particularly for early stage chronic disease, is likely to be a complex and lengthy process that may well be beyond the financial capacity of a single enterprise.
The foundation also offers a way around monopoly and anti-trust regulations that limit direct collaboration between companies.
But critics believe that the FDA should focus more on safety issues, rather than on the balance between safety and benefits, when considering drugs for approval. They prefer an adversarial relationship between the FDA and the industry and worry that initiatives such as the foundation will only increase the industry's influence inside the agency.
In a letter to the agency's commissioner, Andrew von Eschenbach, on 1 November, Representative Rosa DeLauro, a Democrat from Connecticut, wrote: “I believe [the Foundation] has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.”
She feared that biomarkers would be recommended that may not be true measures of efficacy, citing the recent example of rosiglitazone (Avandia), where decreased blood glucose concentrations did not necessarily equal improved health outcomes.
Merrill Goozner, who runs the Integrity in Science programme at the Center for Science in the Public Interest, asked who would set the research agenda, fearing the undue influence of donations from the industry. The foundation “must separate out the grant making process from the fundraising process,” he said.
He added, “There has got to be a great wall between those two processes to protect the scientists and the integrity of the work product.”
The foundation has the authority to use public and industry funds to support research that hastens drug development. But initial federal funding will come from the agency's existing budget and will be little more than $1m (£0.5m; €0.7m). How willing the industry will be to contribute funds to the project is also unclear.