This from the PharmTech talk blog yesterday is a follow up on the HHS report on foreign clinical trials that was discussed here on June 23rd.
The PharmTech post asks if it makes sense to force the FDA increase its scrutiny of clinical trials in foreign countries, not conducted by INDs, given the global nature of the pharma business now. Or should a different regulatory model be developed? Should a different set of rules apply to drugs than to other consumer products?
It is noted that the FDA has limited oversight and financial resources to oversee trials in other countries. Should drugs destined for the US market be required to be clinically tested or manufactured locally? In effect, placing a safety/regulatory driver ahead of perhaps an economic one. Free trade anyone?
As a safety move, the FDA has added offices in China, India, etc. to increase oversight capability. But, does this encourage off-shoring even more clinical trials? I never thought of that. It's a chicken-egg question. I tend to think the economic factors motivate this behavior but does having FDA resources outside the US actually further encourage more activity outside the US? Interesting perspective. Is that something the US Govt (ie. taxpayer) really wishes to support? Are we pitting increased public safety vs decreased domestic jobs?
Upon reflection, I think we're better off supporting a global economy. It makes sense to me to allow development, trials and manufacturing go where it makes most sense economically rather than force the issue with regulatory edicts for domestic manufacture or tariff barriers -- assuming there is relativley open access for all to all markets.
But I also think it makes sense for the US Govt to put favorable policies (i.e. carrots in the form of tax incentives, R&D credits, science infrastructure investment, immigration policy) in place that would entice manufacturers to want to stay in the US and make it more economically feasible to do so.
Then maybe 80% of all drugs won't have clinical trial work from outside the US.
Posted by Bruce Lehr June 30th 2010.