A Dangerous Proposal to Roll Back Pharmacy Compounding Rules

In this issue of Worst Pills, Best Pills News, we discuss the recent conviction of the co-owner of the now-bankrupt New England Compounding Center (NECC) for his central role in the 2012 deadly fungal meningitis outbreak that had been linked to the company’s tainted steroid drugs.[1] In an effort to prevent similar outbreaks, Congress in 2013 passed the Drug Quality and Security Act (DQSA).[2] But now, at the behest of the compounding pharmacy industry, Congress is considering legislation that would reverse the 2013 law.[3],[4]

Drug compounding traditionally involves pharmacists combining, mixing or altering drug ingredients to create customized medications prescribed for individual patients whose medical needs cannot be met by 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 pushed companies that seek to mass produce sterile compounded drugs for 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. This prescription requirement essentially prohibits traditional compounding pharmacies from mass producing drugs for hospitals and doctors’ offices.

In contrast, compounding pharmacies that voluntarily register 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 adhere to federal quality and safety standards for manufacturing drugs and subject themselves to periodic FDA inspections.

The Preserving Patient Access to Compounded Medications Act, 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.[5] In particular, the bill would open a huge loophole in the prescription requirement for 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 federal 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.

References

[1] Bidgood J. Compounding pharmacy owner not guilty of murder after 60 meningitis deaths. March 22, 2017. The New York Times. https://www.nytimes.com/2017/03/22/us/meningitis-new-england-compounding-center-barry-cadden.html. Accessed July 17, 2017.

[2] Congress.gov. H.R. 3204 – Drug Quality and Security Act. 113th Congress (2013-2104). https://www.congress.gov/bill/113th-congress/house-bill/3204/actions. Accessed July 17, 2017.

[3] Congress.gov. H.R. 2871 – Preserving Patient Access to Compounded Medications Act of 2017. https://www.congress.gov/bill/115th-congress/house-bill/2871/text. Accessed July 17, 2017.

[4] Axelrad J. Congress, prevent another outbreak — Don’t roll back drug contamination protections. July 10, 2017. The Hill. http://thehill.com/blogs/pundits-blog/healthcare/341145-why-congress-cant-rollback-protections-from-dangerous-drugs. Accessed July 17, 2017.

[5] Congress.gov. H.R. 2871 – Preserving Patient Access to Compounded Medications Act of 2017. https://www.congress.gov/bill/115th-congress/house-bill/2871/text. Accessed July 17, 2017.