Pharmacy Compounding: The Mess, The Excuse, And The Proposal

The clarion call recently ushered in by the meningitis outbreak related to unsanitary practices at the Massachusetts based New England Compounding Center ("NECC") caused Congress to take a look at a legislative void that has existed since 2002. On November 15, 2012, after hearing compelling and emotional testimony from the family of a victim, a sanctimonious Congress raked an evasive and nonresponsive FDA Commissioner Hamburg over the coals for failing to coherently explain FDA's authority to regulate and oversee the practice of compounding pharmacy generally and for failing to follow up on its 2002 Warning Letter to NECC.

Pharmacy compounding of medications predates the Food Drug and Cosmetic Act and is as old as the practice of medicine itself. The NECC incident highlights the risk occasioned by both the failure of the State of Massachusetts to properly oversee unsanitary practices of a large pharmacy and well as FDA's failure to follow up on a Warning it issued to NECC in, coincidentally, 2002.

While the safety and efficacy of the compound medication itself was not at issue (nor has it been suggested that the medications were improperly prescribed or were not medically indicated), the NECC incident highlights the increasing demand for modified prescription products. Importantly, compounding products are derived not from the highly regulated FDA drug approval process but from the science and art of practicing medicine by individual physicians treating individual patients. But the NECC debacle has been conflated into something that goes far beyond oversight of sanitary practices at large compounding pharmacies that provide these unique products. Congress is now struggling with the decision to grant FDA authority to treat certain compounding pharmacies as "new drug manufacturers" for the purposes of approval, regulation, oversight, inspection and enforcement.

During the November 15, 2012 hearing, unlike the representative of the State of Massachusetts who plainly admitted the state dropped the ball in overseeing NECC, FDA Commissioner Hamburg bobbed and weaved attempting to deflect any responsibility for its failure to act, complaining instead throughout the hearing that the Courts were to blame for making the regulation of Pharmacy Compounding "very complicated." The FDA Commissioner was referring to the 2001 Ninth Circuit opinion in Thompson v Western States 238 F.3d 1090 (9th Cir. 2001) in which the court ruled that the 1997 FDAMA...