While it holds exciting promise for protecting public health, last year's FDA Amendments Act (FDAAA) is actually slowing down new drug approvals, a key agency official warned in June.
FDA Office of New Drugs Deputy director Sandra Kweder cautioned the Drug Information Association's annual meeting in Boston that this legislation is exceedingly complex and, at least in its initial application, is likely to result in delays by FDA in carrying out its individual provisions.
Under the FDAAA, Kweder said, “to assure conformance with provisions of Title IX, every NDA and BLA is a ‘first' so far as the agency is concerned,” she told the Drug Information Association annual meeting in Boston. “Everything we do must be justified, and every letter must be reviewed by the lawyers.”
She pointed out that every application must be considered on a case-by-case basis to determine which provisions apply, and which do not—for example, whether to require sponsors to produce a risk evaluation and mitigation strategy to accompany particular products.