Hatch-Waxman Act and the FDAAA
to examine the legislative origins of
section 1002(a)(1), which requires the FDA to issue regulations establishing standards and definitions with respect to pet food, due to its conflicting nature with the FFDCA and to address the uncertainty it causes for the FDA/AAFCO relationship.
went a significant step further, requiring
However, the FDA did not propose a rule under the FDAAA
 Another study carried out in the USA in 2014 after the introduction of the FDAAA
in 2007 indicated an improvement in publication rates, with 118 out of 400 (29.5%) clinical trials failing to disseminate their results within 4 years of completion.
products." (53) A secondary proposal by the NIH suggests registration and reporting for all NIH-funded trials "regardless of study phase, type of intervention, or whether they are subject to the FDAAA
requirements;" (54) however, as Jennifer Miller, a fellow at the Kenan Institute for Ethics at Duke University, observes, the impact of these initiatives may be limited since "oversight and enforcement by the FDA ...
also required the FDA to set up a website requiring food and pet food manufacturers, packers, processors, handlers, and marketers to report within 24 hours of determining that a food issue has a reasonable likelihood of causing a serious health concern.
(92) Notwithstanding expectations that the FDA would use its enhanced regulatory power under the FDAAA
to more aggressively police postmarket drug use, the agency has demonstrated reluctance to realize the ambitious statutory mandate envisioned by Congress.
(123) Finally, Sharon Jacobs argues practically that the FDAAA
, including its conflict of interest provisions, was reactionary legislation in response to the Vioxx scandal (124) and that its primary effect is little more than unnecessary red tape overburdening an already resource-strained agency.
also created more severe punishments for violators of its transparency provisions.
Drug Safety Initiative and later required by FDAAA
. (31) Its members
* 2007 - FDA Amendments Act (FDAAA
) of 2007 - Numerous amendments to the FDC Act including the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA).