By Sarah Ray,
Recent events have highlighted the need for increased government regulations to uphold the pharmaceutical supply chain and improve existing drug safety measures. Since the contamination of steroidal injections in 2012 — which led to over 750 cases of fungal meningitis — ensuring drug safety has been top priority within the pharma industry and for legislators alike. More specifically, the FDA has sought to increase its oversight on compounding facilities. While the FDA regulates pharmaceutical companies, compounding pharmacies are subject to rules created by individual state boards of pharmacy.
Back in July, I wrote about the price of pharmacovigilance and H.R. 1919: Safeguarding America’s Pharmaceuticals Act of 2013; a piece of legislation proposed by Representative Bob Latta. Last month, another bill emerged at the forefront of drug safety legislation. On September 28, H.R. 3204: The Drug Quality and Security Act was passed in the House of Representatives. Compared with other bills, this bill moved with exceptional speed — its authors (the Committee on Energy and Commerce) only completed the bill’s final draft on September 25.
The overarching goal behind H.R. 3204 is to promote the safety of compounded medication by incorporating measures already proposed in separate legislation. The bill will do this in two ways:
- Clarifying and expanding existing drug compounding regulations
- Establishing a national track and trace system
Like H.R. 1919, H.R. 3204 outlines a plan to strengthen existing pharmaceutical supply chain safeguards by establishing a national track and trace system over the course of the next 10 years. This system will uphold the integrity of the prescription drug supply chain and ideally prevent the distribution of both counterfeit and contaminated drugs. Given that California already has plans to enact a universal standard technology by 2015, this bill is particularly important. If approved by the Senate, H.R. 3204 will establish a national drug safety system while preventing states from developing non-uniform and potentially confusing drug safety regulations on a state-by-state basis.
Similar to Representative Morgan Griffith’s H.R. 3089: The Compounding Clarity Act of 2013, H.R. 3204 would also work to tighten compounding regulations. The legislation would provide the FDA with a greater role in the governance of compounding facilities. The bill clarifies what constitutes an “outsourced facility.” Within its “outsourced facilities” scope, the bill will also cover any drug manufacturers that produce FDA-approved drugs but are not licensed pharmacies. The bill also distinguishes between compounding facilities that manufacture prescription drugs with and without prescriptions for individual patients.
Those in favor of the bill highlight the legislation’s effort to maintain balance between establishing additional drug safety guidance and ensuring patient access to much-needed prescription medications. Supporters of the bill include:
- National Community Pharmacists Association (NCPA)
- Generic Pharmaceutical Association
Yet other groups, including the International Academy of Compounding Pharmacists (IACP), are less enamored of the pending legislation. In particular, IACP argues that the proposed bill does not adequately define which outsourcing facilities will be regulated under this bill. Moreover, its members claim that the legislation will not necessarily guarantee patients’ access to necessary medications.
Despite the recent end to the government shutdown, it remains to be seen how — and perhaps more importantly — if this bill will progress beyond the House of Representatives. If it does, H.R. 3204 would ideally represent a key bipartisan effort toward improving drug safety nationwide.
Update: The Drug Quality and Security Act was approved by the Senate in late October and signed into law on Wednesday (11/27/2013).