The U.S. Food and Drug Administration (FDA) has announced details of its long-awaited reorganization of the Office of Generic Drugs (OGD). The latest update to the reforms regarding the regulator mostly affects appointments to leadership positions.
Under the FDA's plans, the OGD's status will be "elevated" to an office reporting directly to the head of the FDA's Center for Drug Evaluation and Research. This means that the office will not only assume a more prominent position as an entity, but will also have a range of new duties that are currently held by other offices.
The reason for this change in status is tightly linked to the increasing importance of generic drugs for the U.S. pharmaceutical sector. According to the FDA, generic drug prescriptions account for 84% of all prescriptions in the country. One of the main objectives for the FDA is to ensure that U.S. consumers have access to safe, efficient and affordable drug products, and achieving this will largely depend on the new OGD. That is why reorganization of the office is essential, not just as an acknowledgement of the vital importance of generic drugs for public health, but also in respect to their economic importance, the agency said in a press release.
The reorganization is expected to lead to more streamlined processes, resulting in greater efficiency and improved consistency in generic drugs policies, the FDA said.