Monday, May 28, 2012

New biopharma hero: Sen. Rand Paul

Suspend for a moment whatever political party allegiance you may have (D or R for most US readers), and let's celebrate an injection of common sense into the FDA's regulatory regime by Kentucky Senator Rand Paul.

Recently the US Senate passed an FDA-centric bill which allows the FDA to consider clinical trial data sourced overseas outside the FDA's typical authority. (I believe that you can currently use data sourced outside the USA, but only with strict application of FDA rules to the ex-USA trial sites. The new law would allow the FDA to accept data from well-structured trials conducted outside of the auspices of the FDA (but under trials run by other responsible regulatory agencies, such as those in the EU or Japan.) We're not talking about quicky clinical trials in Zimbabwe gaining equivalence to US trials the way a Las Vegas quicky marriage is to weddings elsewhere in the US, but rather acknowledging the competence of other regulators around the globe, and the fact that there may be more than just the FDA's way to run a "good" clinical trial.

Another reform pushed by Paul is the elimination of weapons carrying by FDA enforcement agents. Paul's point here is two-fold: we don't need as many armed bureaucrats when the FBI already exists to handle armed enforcement of Federal law, and 2) it is silly that the FDA conducts raids of any sort against small producers, such as on milk farmers. Seriously, the FDA DOES conduct armed raids on farms to enforce food safety laws. The laws are necessary and enforcement is important, but really, are the guns necessary? Are they for the cows or the milkmaids? Likewise, are weapons necessary to raid the offices of a biopharma company?

(Unfortunately, Paul's amendment ending armed enforcement failed to pass the Senate, likely because his amendment also called for the loosening the rules around advertising of health products..)

We need more common sense in our food and drug regulation. I've previously called for the "D" in the FDA to be spun off into its' own agency, and I think Paul's ideas make a ton of sense.

Hat tip: the very excellent Marginal Revolution blog pointed out this story originally.

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