FDA given new powers over data reporting to national clinical trials registryBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6629 (Published 02 October 2012) Cite this as: BMJ 2012;345:e6629
The US Food and Drug Administration (FDA) has been given the authority to monitor and enforce the reporting of required data to the national clinical trials registry (ClinicalTrials.gov).
Authority for the registry previously rested with the Secretary of Health but was transferred to the FDA on 26 September.1 The move is seen as a streamlining or rationalization of administrative responsibilities and will probably result in enhanced accountability.
The National Institute for Health’s (NIH) National Library of Medicine operates the ClinicalTrials.gov database. A 2007 change in the law required that “basic results” for certain clinical trials, including those submitted to the FDA for drug approval, be deposited with the registry, generally within a year of completion of the study.
However, academics who have monitored the registry say that researchers and the pharmaceutical industry have been ignoring the law or have acted to undercut its intent. The academics laid out their case in several papers published last January in the BMJ.2 3 4 5
In an accompanying editorial, the BMJ’s Elizabeth Loder, and Richard Lehman from Oxford University, said, “These articles confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis—we are talking simply about the absence of the data.”6
Deborah Zarin, director of the ClinicalTrials.gov program at the NIH, told the BMJ that the change was “an anticipate, routine act that will not change any of our plans. We continue to work closely with the FDA and they continue to take the lead on enforcement.”
Iain Chalmers, a founder of the Cochrane Collaboration, said, “It looks like a step in the right direction, but I doubt it will close the big gap between what is required and what is done.”
Whether the administrative change has any practical effect remains to be seen. The FDA has been given no additional resources to administer its added responsibilities, and will probably face budget cuts in a time of austerity.
“Sequestration”—budget cuts of 8.2% across the board for domestic programs—is due to take effect on 2 January 2013, under rules adopted by US Congress last summer as part of a compromise to raise the debt ceiling.
It is uncertain whether sequestration will apply to user fees paid by pharmaceutical companies, which cover 60% of the cost of reviewing a drug submitted to the FDA for approval.
In a report published in September, the White House Office of Management and Budget said that it believed both federal funds used to administer the fees program and the fees collected by the program are subject to the spending limits of sequestration.7
An analysis by FaegreBD Consulting said, “Many companies will not want to be put in the unusual position of paying user fees for additional Food and Drug Administration (FDA) review services but ultimately having those fees diverted instead to help reduce the general federal deficit.”8 It says litigation of the matter is likely.
Cite this as: BMJ 2012;345:e6629