Drug Compounding: Cause and Cure for High Drug Prices?


John S. Linehan, an Associate in the Health Care and Life Sciences practice, in the firm’s Baltimore and Washington, DC, offices, authored an article for PharmExec.com titled “Drug Compounding: Cause and Cure for High Drug Prices?”

Following is an excerpt:

Drug compounding has historically been performed on a small scale in the independent pharmacy or physician office to create customized versions of drugs for patients desiring a more convenient dosage form or flavor. Nevertheless, compounding has grown in scope and prevalence to meet growing market demand for drug products tailored to unique health and cosmetic needs. For several years, this trend progressed unabated in a relatively lenient regulatory environment. However, in 2012, a deadly fungal meningitis outbreak was linked to a Massachusetts’s-based sterile compounding facility—a tragedy that brought to light safety concerns surrounding compounding. Congress responded with the passage of the Drug Quality and Security Act (DQSA), which clarified the FDA’s regulatory authority and outlined a new legal framework to ensure safer compounding practices.

While government action has been taken to address safety concerns, compounding has become one of the central contributors to drug price inflation in the US. According to the Express Scripts Drug Trend Report, overall US prescription drug spend increased by 13.1% in 2014, whereas compounding spend increased by as much as 218% during the preceding two years.