Companies with products under review by the Food and Drug Administration (FDA) are continually frustrated by the slowness of the process of approving new products. Delays of even a few months are enormously expensive to companies.
Moreover, the new Republican majority in Congress has vowed to push for significant reductions in federal spending that could cut as much as 20 percent from some federal agencies budgets. These kinds of cuts in the FDA review process will prove to be painful to the biotech industry. Companies could also be asked to pay additional fees to FDA if taxpayer funding diminishes. In fact, the FDA and the industry are in early negotiations to extend company fees now set to expire in 2012. Taking the lead from FDA, other federal agencies impacting the biotech industry may also begin charging fees.
More than ever, the biotech industry needs the experience, knowledge and federal connections that Cansler Consulting offers.