The proposed changes are wide-reaching and include some things most experts agree are good. On the upside, they say, this is an opportunity to make more information about what FDA does available to the public and ensure that data sources are more user-friendly. The downside, however, is the proposal to disclose information early in the approval process, including Investigational New Drug (IND) applications, holds and IND withdrawals. Few can see how revealing more information at the product application stage can be reconciled with trade secrets protection.
The Biotechnology Industry Organization (BIO) wants more details about how these proposed regulations would be implemented. “They [FDA] define trade secrets [in the document], but oddly there is no definition of what constitutes competitive information,” explains Andrew Emmett, director for science and regulatory affairs at BIO, based in Washington, DC. The organization also wants clarification around who will decide what remains secret. Under current Freedom of Information Act regulations, Emmett says, companies have five days to determine whether documents that are going to be made public contain trade secrets that should be redacted. “We need to know exactly what the role of the sponsor will be in deciding what information is going to be shared,” he says. Otherwise, companies could be put at competitive disadvantage or become victims of wild speculation.
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