Should the Government Regulate Drugs Being Sold Across State Lines?

A meningitis outbreak in the autumn of 2012 affected people in 23 states, killing 55 people and sickening over 700.

The source of the infections was found to be tainted epidural steroid injections made by the New England Compounding Center (NECC) in Framingham, Massachusetts.

Since the outbreak, senators and congressional representatives have introduced legislation calling for new federal regulations of pharmacies that engage in largescale sterile compounding.

Traditionally, compounding pharmacies have made prescription drugs for specific patients whose needs aren’t met by commercially -available drugs.

In recent years, some compounding pharmacies have made custom drugs on a much larger scale. These are the ones targeted by proposed legislation.

In testimony before the Senate Health, Education, Labor, and Pensions Committee, Janet Woodcock, director of the Center for Drug Evaluation and Research for the FDA, said since last fall’s outbreak, investigators have inspected 57 compounding pharmacies and found serious concerns in 47 of them, including insufficient microbiological testing and lack of adequate air filtration systems.

Proposed Federal Regulations

Compounding has typically been regulated by states, while traditional drug manufacturing has been regulated by the FDA. Legislation introduced in Congress makes a distinction between traditional compounding pharmacies that compound on an individual patient basis, and those like NECC, which compound products in advance of prescriptions and ship them across state lines.

Under proposed new laws, compounding manufacturers like NECC would be FDA-regulated under different regulations than traditional drug manufacturers. The law would give the FDA sole regulatory authority over compounding pharmacies engaging in interstate commerce and sterile compounding done in advance of receiving prescriptions. States would continue to regulate traditional compounding pharmacies.

Arguments for Increased Regulation

After the meningitis outbreak, many risks of large scale compounding operations came to light, prompting the proposed legislation. Proponents of the new legislation say that FDA regulation of these entities provides large-scale compounding pharmacies with a uniform set of regulations across states. The FDA would have jurisdiction to go across state lines to enforce regulations and could maintain a database regarding disciplinary action taken against large-scale compounding facilities.

Diana Zuckerman, president of the Cancer Prevention and Treatment Fund and National Research Center for Women and Families, says that proposed legislation “will save lives because it improves safeguards for all types of important medications made by the largest compounding pharmacies.”

Arguments Against Increased Regulation

Though the FDA was criticized after last year’s meningitis outbreak, its legal authority over such companies and products was unclear. David Miller of the International Academy of Compounding Pharmacists has taken issue with some of the details of the proposed legislation, warning they could actually increase confusion over regulatory jurisdiction.

Senator Pat Roberts (R-KS), argued that hospital pharmacies that transfer sterile compounded drugs to their own out-of-state clinics shouldn’t necessarily have to be subject to federal regulation. An example Roberts gave would be Children’s Mercy Hospital in Kansas City, Missouri facing increased regulation just to send compounded medications to its own clinics across the state line in Kansas City, Kansas.

Because of bipartisan support for legislation regulating large-scale compounding pharmacies that ship products out of state, the likelihood of new federal regulations being introduced is high. However, it’s important to note that new laws would only regulate compounding pharmacies that compound custom drugs on a large scale for interstate trade. Traditional pharmacies and compounding pharmacies that make one-off compounds for specific patients as prescribed by physicians would not be affected by the legislation.

eDrugstore.com is not engaged in any form of compounding and had dispensed prescription medications to thousands of satisfied consumers for over 15 years. Proposed new laws would not affect eDrugstore.com’s ability to continue to safely, securely, and discreetly deliver prescription drugs to consumers.

Photo Credits: Sura Nualpradid / freedigitalphotos.net, US Food and Drug Administration