By: Erika Johnson, Senior Associate
ErikaJohnson@cis-partners.com
ErikaJohnson@cis-partners.com
In light of the tragic fungal meningitis outbreak this fall, there are new proposals to the future of compound pharmacies. To understand what is prompting the current heightened Congressional interest in compounding, let’s recap the timeline of these recent events.
Following an outbreak of fungal meningitis in several states tied to use of injectable steroid medications, the product distributor, New England Compounding Center (NECC), voluntarily recalled three lots of methylprednisolone acetate (PF) 80mg/ml on September 26, 2012.[1] The three lot recall grew to include all products in circulation with NECC’s announcement of its Voluntary Nationwide Recall of All Products on October 6, 2012.[2] By October 8, 2012, the Centers for Disease Control and Prevention (CDC) had confirmed eight deaths tied to the outbreak.[3] In response to these deaths, the House of Representatives Committee on Energy and Commerce (the Committee) sent letters to the Director of CDC and Commissioner of the U.S. Food and Drug Administration (FDA) requesting briefings on the CDC and FDA’s responses to the outbreak.[4] & 3
The CDC confirmed the number of deaths had risen to eleven by October 9, 2012.[5] The Committee sent a letter to the Director of Pharmacy and Owner of NECC on October 11, 2012, requesting documentation on the outbreak be retained and a briefing for the committee to be prepared.5 By October 11, 2012, fourteen people had passed away due to the outbreak and the Committee reached out to the Director of the Massachusetts Board of Registration (the Board) in Pharmacy to request documentation of past inspection records and communications from the Board.[6] The Committee specifically cited an inspection of NECC by the FDA and Board that commenced in 2004 and resulted in an FDA warning letter sent to the NECC and the Committee’s investigation of any remedial action taken in light of the issued warning.6
By October 17th, the CDC confirmed fifteen people dead and the Committee sent a sent a request to the Commissioner of the FDA to provide documentation to the Committee of the FDA’s oversight over the NECC.[7] The Committee sent additional requests to NECC for documentation on October 22, 2012.[8] On November 5, 2012, the Committee scheduled a hearing surrounding the outbreak to be held on November 14, 2012.[9]
In her testimony to the November 14, 2012 hearing, the Commissioner of the FDA made several statements regarding the history, evolution, and outlook for the future of compound pharmacies. According to the Commissioner, “FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a licensed pharmacist, in response to a licensed practitioner’s prescription for an individual patient, which produces a medication tailored to that patient’s special medical needs.”[10] She indicated that over the years, traditional compounding had been expanded and the FDA was concerned about the expansion beyond traditional compounding and responded with additional guidance, beginning in 1992.10 The Food and Drug Administration Modernization Act of 1997 calls for certain conditions, including “that the compounding be performed by a licensed pharmacist or physician, that there be a prescription for the compounded product for an individual patient, and that the compounded product be necessary for an identified patient.”10 She indicated the heightened concern of the FDA in light of recent events, including the situation with NECC, of the evolution of compounding beyond traditional compounding, while she indicated there is still a legitimate need for traditional compounding.10 The Commissioner proposed a risk-based approach to compounding that would uniquely define “traditional” and “non-traditional” compounding, in which “non-traditional compounding would include certain types of compounding for which there is a medical need, but that pose higher risks based” on factors such as “the type of product/activity (e.g., sterile compounding); the amount of product being made; whether the production is being done before 12 the receipt of a prescription or order for a particular patient (so-called “anticipatory compounding”): whether the compounded drug is being shipped interstate; or whether the drug is being dispensed to someone other than the ultimate user when it leaves the facility where it was produced.”10 As a result of the inherit increased risk in the “non-traditional compounding,” it would consequently be subject to increased oversight.10
It will be interesting to see how this Congressional interest and these proposals from the Commissioner of the FDA will impact the future of compounding pharmacies.
[1] Health Alter Network. (2012, November 1). Emergency Preparedness and Response. Retrieved November 20, 2012, from Centers for Disease Control and Prevention:http://emergency.cdc.gov/HAN/han00333.asp
[2] New England Compounding Pharmacy, Inc. (2012, October 22). New England Compounding Center Issues Voluntary Nationwide Recall of All Products. Retrieved November 20, 2012, from New England Compounding Center Issues Voluntary Nationwide Recall of All Products: http://www.neccrx.com/
[3] Committee on Energy and Commerce. (2012, October 9). Letter to the Director of the Centers for Disease Control and Prevention. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/sites/default/files/documents/Letter%20to%20Frieden,%20October%209,%202012_0.pdf
[4] Committee on Energy and Commerce. (2012, October 9). Letter to the Commissioner of the FDA. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/sites/default/files/documents/Letter%20to%20Hamburg,%20October%209,%202012_0.pdf
[5] Committee on Energy and Commerce. (2012, October 11). Letter to the Director of Pharmacy and Owner of NECC. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/sites/default/files/documents/Cadden-Meningitis-Letter-10-11-12.pdf
[6] Committee on Energy and Commerce. (2012, October 12). Letter to the Director of the MA Board of Registration in Pharmacy. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/sites/default/files/documents/MassPharmacyBoardMeningitisLetter101212.pdf
[7] Committee on Energy and Commerce. (2012, October 17). 10/17/2012 Letter to the Commissioner of the FDA. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/sites/default/files/documents/Hamburg-FDA-Meningitis-2012-10-17.pdf
[8] Committee on Energy and Commerce. (2012, October 22). Committee Leaders Request Documents Related to Deadly Meningitis Outbreak. Retrieved November 20, 2012, from Committee on Energy and Commerce:http://democrats.energycommerce.house.gov/index.php?q=news/committee-leaders-request-documents-related-to-deadly-meningitis-outbreak
[9] Committee on Energy and Commerce. (2012, November 5). Committee Schedules Hearing on Deadly Meningitis Outbreak. Retrieved November 20, 2012, from Committee on Energy and Commerce: http://democrats.energycommerce.house.gov/index.php?q=news/committee-schedules-hearing-on-deadly-meningitis-outbreak
[10] Margaret A Hamburg, M. (2012, November 14). Statement of Margaret A Hamburg, M.D. Commissioner of FDA before the Subcommittee on Oversight and Investigations. Retrieved November 20, 2012, from Energy and Commerce Committee:http://democrats.energycommerce.house.gov/sites/default/files/image_uploads/Testimony-Hamburg-OI-Meningitis-2012-11-14.pdf
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