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Outrage of the Month: A Dangerous Proposal to Roll Back Pharmacy Compounding Rules

Health Letter, August 2017

Michael Carome, M.D.

In the fall of 2012, Americans watched in horror as national news media outlets for several weeks reported on a widening outbreak of life-threatening fungal meningitis. Scientists at the Centers for Disease Control and Prevention (CDC) quickly linked the source of the outbreak to contaminated vials of the anti-inflammatory steroid methylprednisolone that had been produced by the now-bankrupt New England Compounding Center (NECC) located in Framingham, Massachusetts. The NECC shipped approximately 17,500 vials from three contaminated lots of this drug to 75 medical facilities in 23 states, and more than 13,400 people may have been injected with the tainted drug.

According to the CDC, by the time the outbreak was contained, at least 753 patients in 20 states had been sickened after receiving injections of the NECC’s compounded steroid drug. Sixty-four of these patients died.

On June 26, 2017, Barry J. Cadden — co-owner and head pharmacist of NECC — was sentenced to 9 years in prison after a federal jury in Boston, Massachusetts found him guilty on more than 50 counts of racketeering and mail fraud charges for his role in the fungal meningitis outbreak.

In 2013, in an effort to prevent similar outbreaks from tainted compounded drugs, Congress passed the Drug Quality and Security Act (DQSA). But now, at the behest of the compounding pharmacy industry, Congress is considering legislation that would reverse the 2013 law.

Drug compounding traditionally involves local pharmacists combining, mixing or altering drug ingredients to create customized medications prescribed for individual patients whose medical needs cannot be met by commercially available medications that have been approved by the Food and Drug Administration (FDA). However, since the early 1990s, many companies identifying themselves as compounding pharmacies — such as NECC — expanded their reach by engaging in large-scale production of unapproved drugs. Such companies often supply sterile drugs to hospitals and doctors’ offices across the U.S.

The DQSA, which was passed with broad bipartisan support, pushed companies that seek to mass produce sterile compounded drugs for sale to hospitals and doctors’ offices to voluntarily register with the FDA under a newly created category of companies called “outsourcing facilities.” Compounding pharmacies that do not register as outsourcing facilities must receive a prescription for each individual patient before dispensing any drug product. This prescription requirement essentially prohibits traditional compounding pharmacies from mass producing drugs for hospitals and doctors’ offices, as NECC had been doing in 2012.
 
In contrast, compounding pharmacies that voluntarily register with the FDA as outsourcing facilities are permitted to mass produce sterile drugs for hospitals and doctors’ offices without obtaining such individual prescriptions. But once registered, they must, among other things, adhere to federally mandated quality and safety standards for manufacturing drugs and subject themselves to periodic FDA inspections.

The Preserving Patient Access to Compounded Medications Act of 2017, which was introduced by Rep. H. Morgan Griffith (R-Va.) in the House in June, would eviscerate the critical patient safeguards established under the DQSA. In particular, the bill would open a huge loophole in the prescription requirement for traditional compounding pharmacies and allow any pharmacy to mass produce compounded sterile drugs for hospitals and doctors’ offices. This in turn would eliminate the incentive for companies to register as outsourcing facilities and comply with federally mandated quality and safety standards for manufacturing drugs and other key safety requirements.

Passage of the Griffith bill would all but guarantee another public health catastrophe like the 2012 NECC-caused fungal meningitis outbreak. Congress must place patient safety before compounding pharmacies’ profits by soundly rejecting this dangerous legislation.