The issue of pharmaceutical compounding came to the fore in 2012 when it was reported that more than 50 deaths and widespread serious medical problems were the result of fungal meningitis linked to contaminated products from the New England Compounding Center (NECC).
In early 2013, the Senate HELP Committee, which has jurisdiction over FDA issues, introduced legislation that would distinguish between traditional compounding pharmacies, which make drugs for individual patients based on specific prescriptions, and compounding manufacturers, like the NECC, that make products without, or in advance of, prescriptions for widespread sale.
Under the proposed wording, the compounding manufacturers would be regulated by the FDA and would be required to: register and report the products they sell; report and investigate any adverse events and; pay a fee to offset the cost of inspections. However, an additional requirement would be that all compounded drugs be prepared based on a prescription order.
The original language would have prohibited consumer-ordered OTC compounded drugs, including homeopathic products, and thereby require consumers to incur the cost of a physician visit to obtain the necessary prescription. The practical effect of the bill’s language would be to dramatically increase the cost of certain OTC homeopathic drugs (by requiring an unnecessary physician visit to obtain them) or to simply end their availability. This provision would compromise consumer health care options with no benefit to the public health as compounded homeopathic OTC drugs pose no risk.
Through the submission of formal comments on the draft Senate bill, several Senate office meetings, and regular follow up communications with key Congressional staff, AAHP conveyed to the Senate HELP Committee – and as well to staff of Senators who serve on that Committee—the potential impacts the compounding legislation would have on homeopathic compounded drugs. As a result of AAHP’s sustained lobbying efforts, the Senate HELP Committee leadership (Sens. Tom Harkin and Lamar Alexander) committed to resolving this specific matter.
The House side was also active on the issue of compounding pharmacy legislation. The House Energy and Commerce Committee held two hearings on this subject in the first half of 2013. In June, a draft measure was circulated, which, unfortunately would prohibit OTC compounding without a prescription. AAHP’s federal relations team met with key staffers from the House Energy and Commerce Committee and again highlighted the need to appropriately address the OTC compounding issue so homeopathic compounds would not be inadvertently affected.
Rx Track and Trace Legislation
Both the House and Senate took action in 2013 aimed at better securing the nation’s prescription drug supply chain by establishing a system to track pharmaceuticals from production to patient. The House and Senate measures both contain lot-level tracking, national standards and licensing for wholesale distributors, and pre-empt state pedigree laws.
Given that there has never been a recorded instance of diversion or counterfeiting of homeopathic products, along with the high cost of implementing the supply chain requirements contained in the track and trace legislation for the few Rx homeopathic drugs that are available in the U.S, the AAHP federal relations team petitioned Congress to exempt Rx homeopathic drugs from the current track and trace legislation.
The lobbying effort on this issue has included: gathering information on existing Rx homeopathic drugs, submitting formal comments to the Senate HELP Committee, several meeting with key staff of the Senate HELP and House Energy and Commerce Committee, and extensive follow-up communications with Committee staff. As the result these efforts, the Senate HELP Committee amended its track and trace legislation to exempt “homeopathic drugs marketed in accordance with applicable FDA guidance” from a track and trace regulatory scheme.
As the two chambers met through the year, the two above mentioned bills were combined into one piece of legislation, the Drug Quality and Security Act. Late in the year, this legislation passed both chambers and was signed into law. “Americans must have the confidence that their drugs — whether obtained at a hospital, at a doctor’s office or at the pharmacy counter — are safe,” said Tom Harkin, D-Iowa, Chairman of the Senate Health, Education, Labor and Pensions Committee.
In its final language, the law establishes “outsourcing facilities”, a category for pharmacies conducting large-scale compounding of sterile drugs, who could choose to be categorized for oversight by the FDA. The bill requires the Agency to conduct risk-based inspections of such facilities. Detailed labeling of such compounded drugs and the collection of fees to pay for the agency oversight are also required. State regulation of traditional compounding pharmacies would continue; it will be voluntary for companies to choose to join the new category and its associated FDA regulation.
The bill also creates a national electronic system for unit-level tracking of prescription drugs through out the distribution chain; this will preempt varying state regulations. All entities in the supply chain, (manufacturers, wholesale distributors, pharmacies and repackagers) will be required to maintain detailed records of the transactions.
Of particular importance to the homeopathic industry is the specific inclusion of an exemption for homeopathic drugs from compliance with certain provisions of this law. As AAHP Counsel points out, this is the first time that the word “homeopathic” has been included in a piece of federal legislation since the 1938 Food, Drug, and Cosmetic Act.