Federal efforts to remedy the regulatory failures that led to last fall's deadly fungal meningitis outbreak moved a step closer to reality on Sept. 28 as the U.S. House of Representatives passed the Drug Quality and Security Act.
The legislation would strengthen the FDA's authority over larger compounding pharmacies that manufacture customized medicines in bulk quantities for intra- and interstate distribution. The bill also establishes a "track and trace" system to monitor the distribution of prescription medicines from manufacture to end user. The measure seeks to prevent counterfeit drugs from entering the pharmaceutical supply chain.
The new legislation, which was finalized by House and Senate committee members earlier this week, focuses largely on correcting the regulatory no-man's land between traditional compounders and pharmaceutical manufacturers by creating a new class of nontraditional compounders, called "outsourcing facilities." Under the bill, outsourcing facilities would have to register annually with the FDA and submit twice-yearly reports identifying the drug products compounded during the previous six months. However, registration would be voluntary. Outsourcers with annual revenues exceeding $1 million would have to shell out substantial registration and inspection fees that would go to pay for oversight costs.
While regulation of traditional compounders would remain under state pharmacy board jurisdiction, the bills would demand much greater communication and cooperation between the FDA and state boards.
Paul W. Abramowitz, PharmD, ScD (Hon.), chief executive of the American Society of Health-System Pharmacists, said in a statement that "overall, ASHP is supportive of this proposal. The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers." Dr. Abramowitz added, however, that the organization was "disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer risk-based criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding."
Outsourcing facilities could also elect to remain classified as traditional compounders. Dr. Abramowitz said that loophole "leaves the door open for large-scale compounding pharmacies to potentially behave like manufacturers without the oversight of the FDA."
The bill does not specifically address one concern of health system and hospital pharmacies. That is, they want to maintain their status as state-regulated traditional compounders, with the freedom to prepare medicines and nutritional supplements for both individual patients and in larger quantities for anticipated needs based on historical demand, without the additional federal regulatory burden imposed on outsourcing facilities.
The Senate's original version of the compounding legislation issued last May contained clear language granting them that status, but it is not included in the new Senate-House bill.
The central thrust of the new bill is ensuring medication safety. Lawmakers want to avoid another public health disaster like last fall's meningitis crisis, which ultimately claimed 64 lives among 760 individuals with confirmed fungal infections attributed to contaminated methylprednisolone injections made by the now-shuttered New England Compounding Center. Stepped-up inspections by the FDA and state pharmacy boards over the last year have uncovered many more instances of pharmacies in violation of sterility standards, most of them larger compounders that make and distribute products to doctors' offices, health systems and hospitals across the country.
Under the new bill, pharmacies would be prevented from compounding complex, difficult-to-manufacture products. The new bill doesn't specify which products, but the original House version issued earlier this month cited examples such as biologic drugs, metered dose inhalers, transdermal patches and sterile liposomal products.
The new bill also requires that any pharmacy compounding a drug subject to a risk evaluation and mitigation strategy (REMS) would have to demonstrate prior to compounding that the pharmacist or physician is using controls comparable to those applicable under the REMS.
It would also prevent compounders from making copycat versions of patented and approved drugs, but would grant leeway for drugs in short supply.
The National Community Pharmacists Associating strongly endorsed the bill. "This compromise legislation appropriately addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain," said R. Douglas Hoey, RPh, MBA, chief executive officer of NCPA.
Not everyone expressed support for the new bill, which now goes to the Senate for a vote. Michael A. Carome, MD, deputy director of Public Citizen's Health Research Group, said the bill would "make it easier for companies like the NECC to manufacture substandard drugs like the one that caused the outbreak" without FDA approval "under the guise of pharmacy compounding." Dr. Carome said the agency already has the authority to take action against pharmacies "that engage in illegal compounding, but the agency has failed to fully exercise this authority."
He also said the creation of the new category of outsourcing pharmacies would allow companies, registering under this designation, to "mass-produce standardized drug products without seeking FDA premarket approval, particularly during drug shortages. This kind of large-scale production is not compounding, it is manufacturing."