Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 92

In 2007, PDUFA was actually a part of major new legislation known as the Food and Drug Administration Amendments Act (FDAAA) of 2007.

The FDAAA has multiple parts. The ones that deal with post-marketing safety are known as Title IX and give enhanced authority to the FDA regarding safety. In particular, it created the concept of Risk Evaluation and Mitigation Strategies (REMS), which are briefly outlined in this chapter and described in more detail elsewhere.

Another section strengthened the FDA’ s authority to unilaterally modify product labeling. Before 2007, the FDA did not clearly have the power to force labeling changes and most changes were done on a “voluntary” basis, though the FDA, in practice, could force most changes they desired. FDAAA formally empowered FDA to “notify” the applicant of new safety information that the agency “believes should be included in the labeling”. The applicant then has 30 days to submit an amendment proposing new labeling that reflects FDA’s communication or to notify the FDA that it disagrees and why. FDA may then have discussions with the applicant that usually last no more than 30 days, after which time the FDA may force the applicant to make labeling changes that the agency “deems appropriate”. The FDA has used this new authority on several occasions, including the addition of a black box regarding an increased risk of death in elderly patients treated with antipsychotics for dementia, the addition of a black box regarding an increased risk of tendon injury with fluoroquinolone antibiotics, and the addition of a black box regarding the risk of histoplasmosis and other fungal infections with TNF alpha-blockers.

Other sections deal with the following:

Pre-approval review of proprietary names;

Modernization of information technology;

Medical devices, including enhancements in the device review program, inspections by third parties, new requirements for certain single-use devices, and user fees;

More studies in the pediatric population;

Development of products for tropical diseases, rare diseases, and other “neglected” diseases;

The Reagan–Udall Foundation, made up of senior advisers from outside the federal government, to advise FDA on innovation and enhanced food and drug safety. (the foundation was not initially funded by Congress, but sustainability models are evolving):

More transparency regarding possible conflicts of interest is required for potential Advisory Committee participation; and

The clinical trials database was expanded.