Nanodrugs in the Post-Blockbuster World – Critical FDA Regulatory and Patent Issues

When: Friday, November 15, 2013 at 1:00 pm
Where: SNL 121
Speaker: Raj Bawa PhD
Organization: President and Patent Agent, Bawa Biotech LLC
Sponsor: IGERT Nanomedicine Seminar

In today’s global economy, pharmaceutical companies are under enormous pressure to maintain profitability in light of numerous challenges ranging from revenue losses due to patent expirations on blockbusters to enhanced regulatory oversight to an ever-increasing challenge from generic manufacturers. This coupled with the fact that there are numerous market forces and drivers dictating a change in pharma’s quest for discovering, developing and delivering novel therapeutics, is altering the pharma landscape. Clearly, new ground rules and competitive business strategies are needed in the post-blockbuster world.

Emerging technologies, like nanomedicine, also bring with them concerns and uncertainties about how they should be regulated. While complex nanodrugs and nanosimilars hold great promise for addressing some of the most challenging issues in nearly every medical specialty, the US Food and Drug Administration (FDA) has yet to formulate “official” regulatory guidelines for these nanoproducts. The safety and efficacy of nanodrugs can be influenced by minor variations in their structure, composition and the bioenvironment of use–areas that are still poorly understood. Therefore, many experts believe appropriate characterization of these medicines may, in some cases, require clinical trials to ensure the safety of patients. It is generally accepted that regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection. The FDA has struggled to handle the issue of nanogovernance. Clearly, guidance is critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers and the consumer. However, the “baby steps” the FDA has undertaken over the past decade are generally considered inadequate and have contributed to regulatory uncertainly.