On Monday November 18, 2013, the U.S. Senate passed a bill, by voice-vote, which had earlier cleared the House, moving the legislation on to President Obama’s desk. H.B. 3204 the Drug Quality and Security Act (“DQSA”) passed with bipartisan support, a rare occurrence of late. The DQSA creates a national system which will track the movement of prescription drugs from manufacture to distribution, similar to the tracking methods used for food products. Perhaps most importantly, the law provides for oversight of pharmacies engaged in drug compounding by the Food and Drug Administration (“FDA”).
The law was drafted in response to a fungal meningitis outbreak last winter which resulted in 751 reported cases and at least 64 confirmed deaths. Public health officials traced the outbreak to the New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts. Traditional compounding pharmacies uses a variety of methods to process or combine different pharmaceutical materials to create tailor-made products to fit the unique needs of individual customers. However, in recent years non-traditional compounders have gained prominence, mixing and compounding large quantities of product for sale and shipment throughout the country. According to the Centers for Disease Control (“CDC”) the meningitis originated from deadly black mold found in injectable steroids made by the NECC.
Perhaps the DQSA’s biggest flaw is its structure of voluntary disclosure and lack of intrastate oversight. Rather than requiring registration by all compounding pharmacies nationwide, the law encourages them to voluntarily register with the FDA. Entities that choose to do so must meet good manufacturing practices, remain in compliance and pay certain fees. This in turn grants the compounding pharmacy the right to ship product across state lines. Notably, the law does not regulate intra state movement of compounded pharmaceuticals.
As any whistleblower attorney, worth his or her salt, will readily comment, leaving companies the option to submit to compliance standards will likely lead to troubles down the road. A number of House and Senate democrats appear to share this sense of skepticism. Rosa DeLauro, a Democratic Congresswoman from Connecticut, recently commented that the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”
Young Law Group is a nationwide leader in whistleblower representation and has successfully represented numerous clients in some of the nation’s largest qui tam cases for over a decade. For a free confidential consultation, please call Eric L. Young, Esquire at (800) 590-4116 or complete the online form here.