I've been meaning to take a quick look around the pharma and life sciences sector for the ol' blog for a while. No time like the present. Now that SFDA has finished with the executions and restructuring and is now moving forward with the business of regulatory work, how are things going? And what are some trends from the foreign side?
Here are a few things that have floated into my inbox the past couple of weeks:
1. Americans realize that <shudder> some of their medicine is being manufactured in China. Holy crap! Call a cop! To make things worse, the U.S. FDA recently admitted that they do not have the staff to inspect overseas facilities. Ooops. Some folks are nervous.
This is my favorite hysterical post on the topic. Here's a much better one. The story that kicked all of this off, I think, was this article by Tim Johnson. Lucky for all the folks back in the States, China and the U.S. will sign an import safety MoU perhaps this week that covers drugs and medical devices. Everyone can relax now? The U.S. FDA might also open an office here in China – maybe they can rent some space here in the Kerry Centre next door to the INS guys (true, INS is next door).
2. An obscene amount of money is being invested in local biotech firms. Some of this is R&D money, some is for production, etc. Lots of activity, lots of cash, lots of B-school types running around gushing about the prospects for this sector, although since I cannot exactly decipher business school lingo, that last statement is kind of an assumption on my part.
Here's a great post that encapsulates the happy happy mentality of the industry right now.
3. SFDA plays tough guy. After their horrible PR the last 18 months or so, the regulators are trying to look good. And how do we know they are doing a good job of enforcement? Numbers, of course. Lots of numbers!
China Shuts Down 300 Drug Manufacturers – this one has lots of lovely enforcement statistics for those of you keeping score at home. And if that isn't tough enough for you, how about the death penalty for drug counterfeiters? That's the latest policy advice from SFDA. Bring 'em on.
4. Finally, outsourcing clinical trials. This is a popular topic, whereby researchers in the US and EU sound the alarm bells about informed consent, paying patients to participate in research, and other ethics issues. And meanwhile, more and more pharma companies keep coming over here to do their clinical research anyway. Funny how that goes, huh?
OK, enough pharma phun.