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 Pharmacy Compounding provisions (21 USC § 353a) were invalid on First Amendment grounds. The case eventually worked its way to the Supreme Court where the Court affirmed the Ninth Circuit, but the Supreme Court did not resolve the issue of whether the entire Pharmacy Compounding provision was invalid leaving the Ninth Circuit's opinion intact. 535 U.S. 357 (2002). Despite the statutory void, FDA was not without significant authority under the provisions of the FDCA and regulations concerning adulteration to take immediate action under circumstances presented by NECC even in the absence of the Pharmacy Compounding provisions. 21 USC § 351. As a result of the Western States opinion, in 2002 FDA issued its Compliance Policy Guide for Pharmacy Compounding("CPG").
While FDA has been "regulating" pharmacy compounding under the force of the CPC, it is merely a compliance guide that does not have the force of law.
The "complexity" the Commissioner alluded to at the November 15, 2012 hearing did not come about until 2007 when the Fifth Circuit disagreed with the Ninth Circuit on the severability of the advertising provisions and ruled the 1997 FDAMA Pharmacy Compounding provisions were in effect (minus the advertising provision the Ninth Circuit and US Supreme Court found violated the First Amendment). In response to the Fifth Circuit "complicating" matters in 2007, FDA issued its notice explaining that FDA would continue to regulate this area of the law under its CPG.
Following the NECC meningitis outbreak, Congress has proposed legislation entitled the Verifying Authority and Legality in Drug Compounding Act of 2012." This proposal has much in common with the current/prior Compounding Act (21 USC 353a) but differs in that it provides for registration, inspection rights, adverse event reporting and "manufacturing" in advance of prescriptions based on an FDA waiver. If the hearing before Congress on November 15, 2012 is any guide, Congress intends to push through legislation before the end of the year. No doubt that clarity is needed, but as we saw with the Compounding Act in 1997, if Congress fails to take the time to carefully reason through this issue, the Court will once again be forced to sort it out.
Irrespective of what FDA or the State of Massachusetts could or should have done to prevent NECC from distributing adulterated products, the current legislative and regulatory train-wreck of Pharmacy Compounding lies at the door step of Congress where it has been for over 10 years.
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