Congress Clears Drug Safety Bill

Legislation intended to prevent future public health crises related to counterfeit and contaminated prescription drugs cleared the Senate and headed to President Barack Obama for signing into law last week. The bill establishes a national system for tracking prescription drugs throughout the supply chain and boosts federal oversight of large-scale compounding pharmacies that act as drug manufacturers.

The pharmaceutical industry and public health groups welcome the legislation. “The counterfeiting of prescription drugs is on the rise,” says John J. Castellani, president of Pharmaceutical Research & Manufacturers of America, an industry group. “This act will improve the security of the finished drug supply chain,” he notes. The legislation will help save lives, stresses Allan Coukell, senior director of drugs and medical devices at the nonprofit Pew Charitable Trusts, by ensuring that prescription drugs are “safe, effective, and of the highest quality.”

Momentum for the Drug Quality & Security Act (H.R. 3204) increased after last fall’s deadly outbreak of fungal meningitis that was linked to contaminated steroid injections produced by the New England Compounding Center. But not everyone is convinced that the legislation will prevent such tragedies in the future.

The bill encourages large-scale compounding pharmacies that distribute products across state lines to register with the Food & Drug Administration as “outsourcing facilities,” but it does not require them to do so. This new category of facilities will be regulated by FDA like drug manufacturers, whereas traditional compounding pharmacies will still be regulated at the state level.

Critics of the bill question whether large-scale facilities will voluntarily subject themselves to stringent drug regulations. “Ambiguity remains as to what facilities will in the end be subject to FDA oversight,” says Glenn Engelmann, vice chair of the life sciences industry group at the law firm McDermott Will & Emery. Others counter that market forces will lead large-scale compounding pharmacies to register with FDA so that they are more attractive to hospitals and other providers that purchase their products.

The bill also establishes requirements for a national system to electronically track prescription drug products throughout the distribution chain, from manufacturers to pharmacies. The system will be phased in over 10 years. Such traceability requirements currently vary from state to state.