Congress, prevent another outbreak — Don't roll back drug contamination protections
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In September 2012, contaminated medications distributed by a state-licensed compounding pharmacy, the New England Compounding Center, caused a fungal meningitis outbreak that killed more than 70 people and injured 750 in 20 states. States hardest hit were Michigan (264 patients), Tennessee (153), Indiana (93), Virginia (56), Florida (25) and Ohio (20).

On June 26, Barry Cadden, the owner of the New England Compounding Center, was sentenced to nine years in prison for crimes he committed related to the outbreak.

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In 2013, Congress enacted bipartisan legislation to prevent such an outbreak from happening again. Now, after heavy lobbying from pharmacies and practitioners who are losing lucrative business because of those protections, the Agriculture Subcommittee of the House Appropriations Committee this week included report language and Congress is considering legislation that would gut the law and place patients at risk.

 

Compounding is the process of combining, mixing or altering drug ingredients to create a new medication. Compounded drugs are not FDA-approved. They are supposed to be customized to meet an individual patient’s needs when an approved product cannot, but many pharmacies are engaging in mass-production of drugs without obtaining individual prescriptions. In the 2012 outbreak, because of insanitary conditions at one compounding pharmacy, injectable medications that needed to be sterile were contaminated by fungus and subsequently administered to more than 14,000 patients. 

In the wake of the outbreak, Congress passed the Compounding Quality Act (CQA). For pharmacies primarily regulated by the states, the CQA retained requirements first established in 1997 that the drugs they compound must meet certain conditions, including that they be produced pursuant to a prescription. The prescription requirement is an essential limitation on the mass production of drugs and reduces the potential for widespread harm if the drugs are contaminated during compounding.

To ensure that hospitals, physician offices and other healthcare settings have access to compounded drugs that they may need on hand for patient care but that are not made for a specific individual (i.e., “office stock”), the CQA also created a new category of compounder called an “outsourcing facility.” Outsourcing facilities can compound drugs without obtaining prescriptions, but they are subject to federal requirements necessary to ensure quality as well as other safety requirements commensurate with the higher risk created by mass produced compounded drugs. Outsourcing facilities are primarily regulated by FDA.

Almost five years have passed since the outbreak, and it has become clear that the outbreak was not an isolated incident. For example, in Texas two people died and 15 people developed bacterial bloodstream infections from a compounder’s contaminated drugs. In another case, 26 patients experienced adverse events, including skin abscesses, after receiving drugs compounded in Tennessee and distributed to healthcare facilities in 17 states.

The FDA has inspected more than 400 compounders, and numerous pharmacies have had to cease operations as a result of problems found at their facilities. The FDA has overseen more than 125 recalls of products compounded under substandard conditions, and worked with the Department of Justice on civil and criminal enforcement actions.

Despite this history, Congress is considering legislation, and a House Appropriations Subcommittee has included report language, that would undermine the CQA’s patient protections. The compounding pharmacy industry is trying to convince Congress to prohibit the FDA from enforcing the prescription requirement that Congress instituted 20 years ago and re-affirmed just four years ago. This would allow precisely the circumstances that led to the 2012 outbreak: compounding pharmacies mass producing drugs for healthcare facilities and doctors’ offices around the country without complying with requirements necessary to ensure quality and safety.

Without the prescription limitation in federal law, states that have prohibited their own pharmacies from shipping compounded drugs without prescriptions would be unable to protect their citizens from drugs compounded by pharmacies located in states with lax oversight of drug compounding. Unsuspecting patients in healthcare facilities would be at risk of receiving compounded drugs that have not been proven safe and effective and that also may have been made under unsafe conditions. 

When it enacted the CQA in 2013, Congress created the new voluntary category of outsourcing facilities. Instead of requiring compounders that want to supply compounded drugs without obtaining prescriptions to become outsourcing facilities and adhere to higher standards, Congress decided to rely on market forces to encourage pharmacies to adopt this business model. More than 70 facilities have voluntarily registered with FDA as outsourcing facilities, providing millions of units of medications to healthcare facilities, doctors offices, and clinics. If Congress eliminates the prescription requirement, it would remove any incentive for compounders to register as outsourcing facilities and comply with the standards that are necessary for the safety of higher volume, non-individualized compounding.

When it considers this issue, Congress must not forget the suffering of the patients and families harmed by the New England Compounding Center and the lessons of the past five years. Eliminating the prescription requirement will turn back the clock and remove the protections Congress itself put in place to prevent another outbreak. And an outbreak will surely happen. It will just be a matter of when.

Jane Axelrad, Principal, Axelrad Solutions LLC, was the associate director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration for 25 years. Following the fungal meningitis outbreak, Axelrad was the agency lead on pharmacy compounding. 


The views expressed by contributors are their own and are not the views of The Hill.