While we generally confine our comments on FDA matters to Food and Dietary Supplements, the lessons of the ongoing regulatory failure in the compounding pharmacy scandal should prove valuable to regulatory food science professionals. As always we believe that knowledge is best attained by reading original documents as opposed to press "coverage".

Therefore, we post the Markey Report (10/29/2012) and the important US Supreme Court Decision, Thompson v. Western States Medical, 535 US 357 (2002).

A particularly interesting aspect of the Western States decision is that then Chief Justice Rehnquist joined in the dissent written by Justice Breyer (also joined by Justices Ginsburg, and Stevens).

As of the date of this post, there have been 25 deaths in the ongoing meningitis outbreak associated with injectable steroids manufactured by a state regulated compounding pharmacy.

The incident is worthy of careful study because of the failure of all three branches of government: Congressional failure to remedy defects in FDAMA 1997; the judiciary's failure to balance First Amendment considerations against public health; and failure of FDA to assert authority and leadership.

On this final point, the failure of FDA to lead, we are particularly persuaded by the comments of Peter Barton Hutt as quoted in the Washington Post on October 11. We strongly suggest to readers that they follow the excellent coverage of the incident in a series of articles in the Washington Post.