I haven’t been involved in the pharmaceutical industry too long, but long enough to have learned that regulations are the bane of manufacturers’ existence. I’m actually a proponent of stringent regulations—perhaps because I’m somewhat of an outsider and don’t have to deal with the actual paperwork or inspection process. But given the extreme cases of contamination (e.g., heparin, melamine, DEG) and violations of late, even among large, well-respected pharmaceutical companies (e.g., Bayer’s unapproved drug marketing, Ranbaxy’s GMP-facility violations), it seems that strict oversight and controls are truly necessary.

This is where the incoming Obama administration comes to mind. Several experts and industry leaders are predicting the president-elect to raise the stakes on regulatory authority as well as manufacturers’ accountability. Some areas that may receive specific attention, in addition to the obvious increase in foreign inspections and supply-chain controls, include environmental concerns.

If you watched any of the three presidential debates, you know Obama is big into “green” efforts. It’s also of interest that Obama’s choice to lead the Energy Department, Stephen Chu, is a Nobel Prize-winning physicist and a professor of physics and molecular and cell biology at the University of California-Berkeley. More in-depth connections among the environment, healthcare, and pharma may not be too far off. Areas such as sustainable chemistry, green manufacturing, green bioprocessing, and so forth, could grow significantly over the next four years.

 Personally, I think this is all good news. But I’d like you hear your insider views. Leave a comment below or email me directly (adrakulich@advanstar.com).