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Making drug and device regulation more transparent — FDA invites public comment on proposals

As part of its longstanding efforts towards providing greater accountability, the US Food and Drug Administration (FDA) has just released a set of proposals from its Transparency Initiative for public comment. The four key motivations behind these proposals are to provide better explanations for FDA decisions; to give more data to doctors and patients; to help enforcement by the agency, and to support innovation, by incentivising drug development.

Some proposals are radical, and crucially would enable FDA to publicly reveal information regarding applications from drug companies to conduct studies on investigational (new) drugs, as well as applications for marketing approval. FDA proposes that for “investigational applications, the disclosure should include the name of the application sponsor, the date the application was received, the proposed indication(s) or intended use(s) of the product, and the proposed proper and/or trade name of the product…”. The agency would be empowered to reveal safety and effectiveness information from ongoing drug applications, if it believes that the disclosure is in the overall interests of public health – for example to counteract misleading information about the drug. Decisions about unapproved drugs (currently not made publicly available) would also be disclosed. These measures (which would probably require legal changes) are likely to be resisted by industry — prior feedback on the proposals included comments from industry that “additional disclosure of information about clinical trials is not needed to protect subjects participating in clinical trials that are testing similar medical products because FDA oversees clinical trials and will prevent any unnecessary risks to subjects”. However, FDA envisages that revealing information about failed drug applications would prevent future harm to patients who might otherwise be enrolled in trials of similar agents, as well as preventing duplicative research being done.

In some respects, these initiatives bring FDA closer into line with the way in which medicines are regulated in Europe, where information about drug applications and refusals are made publicly available. All interested parties have until July 20th to comment on the FDA proposals via its website.

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