Alexandria, Va. Sept. 5, 2013 - National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA has written to the House Energy and Commerce Committee Chairman and Ranking Member to reiterate the views of independent community pharmacists on how to help prevent a recurrence of the 2012 meningitis tragedy, while preserving patient access to customized medications that are prescribed by physicians and prepared or "compounded" by community pharmacies when off-the-shelf, manufactured drugs are not an option.
The House committee has conducted an investigation and held several hearings into how the meningitis outbreak was handled by the Food and Drug Administration (FDA) and state regulators and, as Congress returns from its August recess, the panel is actively considering what policy or legislative changes may be necessary to avoid a similar public health crisis from happening again.
"Compounding is the backbone of pharmacy practice and for many decades independent community pharmacists have provided millions of adults, children, and animals with access to safe, effective and affordable medications through compounding services," Hoey wrote to Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.). "Compounding can help bridge the gaps during times of drug shortages. Drug shortages have nearly tripled, according to the FDA, and their impact can be devastating."
NCPA's letter articulated the following additional points:
The House panel has conducted laudable work reviewing the meningitis outbreak and, going forward, lawmakers should avoid acting or legislating "in a manner that interferes with the triad relationship of patient-physician-pharmacist, and prevents patients from obtaining their necessary compounded medications."
NCPA cannot support a Senate proposal (S. 959) as currently written because it would inadvertently "create unnecessary federal regulatory burdens, hamper independent community pharmacies from providing medications to patients with unique health needs, and far exceeds a targeted approach to prevent another tragedy such as NECC."
Specifically, S. 959 would require community pharmacies to report directly to the FDA when they are compounding medications to alleviate a drug shortage. In addition, S. 959 would jeopardize patient access to vital medications by directing FDA to maintain a "do not compound" list which could potentially be used by the agency to prevent compounding in response to a doctor's prescription for medications such as hormone medications, thyroid preparations, promethazine gels and medications to treat autism.
Instead, NCPA supports the efforts of Rep. Morgan Griffith (R-Va.) to develop bipartisan House legislation based on the "discussion draft" legislation posted on the committee's Website. The proposal "rightfully maintains state board of pharmacy oversight of traditional compounding pharmacies while strengthening badly needed two-way communications between the FDA and state boards of pharmacy." Poor coordination and communication between FDA and state boards of pharmacy were a vital factor that prevented regulators from stopping or mitigating the impact of the meningitis outbreak. Other provisions in the legislation would protect patient access to essential medications from pharmacies at hospitals and physician's offices, yet clarify the authority of FDA and other regulators to go after any bad actors, such as the New England Compounding Center (NECC).
"NCPA looks forward to working with Congress to preserve access to vital compounded medications while best addressing the practices surrounding the NECC tragedy," Hoey wrote in conclusion.