Monday, November 4, 2013

Tennessee Voices: Proposed law would strengthen oversight of large-scale drug compounders

The fungal meningitis epidemic remains in the news, with patients still coping with long-term complications more than a year after this tragedy came to light.

Late last month, the U.S. House of Representatives passed bipartisan legislation to strengthen federal oversight of a largely unregulated and sometimes unsafe pharmacy practice. We are thankful Tennessee's senior senator, Lamar Alexander, has played a leading role in drafting this important legislation.

During the summer of 2012, more than 700 Americans went into clinics across the country to receive treatment for back pain and other conditions. They walked out with fungal infections. Sixty-three died and hundreds more are still struggling to recover.

Twelve of these patients have been cared for at Vanderbilt University Medical Center. They suffered strokes, impaired mobility, problems with speech and cognition, and worsened pain. Many required surgery for focal spine infections occurring after they recovered from meningitis. Most have improved, though they still are not as healthy as they were before they became infected. Several are still receiving therapy.

At the root of this outbreak was a steroid injection that was contaminated with fungi. Doctors unknowingly administered this tainted drug to their patients.

Sadly, this outbreak was not the first — or the last — of its kind. Between 2001 and 2012, there were at least 20 similar events that sickened hundreds of people. And since last year’s outbreak, at least three new incidents have injured more than 40 people.

Our country has one of the most robust drug regulation systems in the world. So how is it possible that patients continue to be harmed by unsafe medications?

The answer lies in the unchecked expansion of a traditional pharmacy practice known as drug compounding. U.S. laws permit pharmacies to compound customized medicines to meet patients’ unique needs. This is a primarily state-regulated activity. Indeed, compounding pharmacies provide a small number of patients with much-needed, individualized alternatives to manufactured drugs. But over the years, this practice has expanded and now includes companies that mass-produce large batches of drugs and ship them to dozens of states.

While these compounding companies grew, oversight systems did not. The facility that made the contaminated spinal injections was operating like a drug manufacturer, but it was being regulated like a small pharmacy.

Unfortunately, this regulation is not something the states can do well. State regulators oversee pharmacy practice, and should continue to do so, but large-scale compounding that involves the mass production of drugs for use in clinics and hospitals across the country is not traditional practice. The U.S. Food and Drug Administration needs to oversee this activity. Its inspectors are properly trained to ensure the quality and safety of the large-scale production of medicines.

In a testament to the importance of this issue, Congress has put partisan politics aside to advance legislation to improve oversight systems for pharmaceutical compounding. The Drug Quality and Safety Act (H.R. 3204) clarifies federal rules for compounding pharmacies and creates a new category of so-called outsourcing facilities that may elect to compound drugs without prescriptions while under monitoring by the FDA. This law will help ensure future patients are not exposed to unsafe medicines made without being subject to industry quality standards.

We have learned a harsh lesson from this tragedy. Our lawmakers should do everything they can to seal up the regulatory cracks that enable unsafe drugs to reach patients. We urge the Senate to pass this legislation and President Obama to sign it. Patients, and the medical professionals who serve them, expect their medicines to be safe. They deserve the protection this law would provide.

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