On Monday, August 8, 2011 the US Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register (Volume 76, No. 152) regarding cranial electrotherapy stimulation (CES). This action is directed to the entire CES industry and not just Alpha-Stim CES. They have opened a 90 day public comment period on CES. This 90 day period is for FDA to receive public comment on the possibility of down-classifying CES from Class III to Class II or requiring Pre-Market Approval (PMA) in the USA. At the end of this comment period FDA will issue a final rule which will either down classify CES to Class II or will call for all CES manufacturers to prepare PMA Applications. While FDA conducts its review of these PMA’s, legally cleared CES devices may remain on the market in the USA.
EPI has been through this and similar FDA rulings many, many times over its 30 year history. We are confident in our ability to produce the necessary science and safety data to meet the statutory requirements. However, FDA has consistently acted in an arbitrary and capricious manner in regulatory reviews submitted by EPI regarding CES. Because of this history we are not confident that a fair review is possible by FDA and therefore there is a real risk of CES being removed from the market in our country.
As always, EPI will comply with this rule making process under the guidance of its expert legal team. We will pursue all means necessary, but we need your assistance for CES to remain on the market in the USA. It is vital for the public to take advantage of sharing with FDA, through this public comment period, its opinion, whether expert or lay, of the effectiveness of Alpha-Stim CES. In this proposed rule, FDA is asserting that CES is not effective and therefore CES manufacturers should be required to complete the very expensive and time consuming PMA process. This ruling notes a price tag of $1,000,000 for the preparation of the PMA application by the sponsor (EPI) and an $8,490,000 cost to taxpayers for FDA to review the PMA’s submitted as a result of this action! It is EPI’s expert opinion that there is more than ample scientific evidence in existence to provide “reasonable assurance” that Alpha-Stim CES is safe and effective for its indications.
Please share your comments regarding your experiences with CES, including your opinion of harm that may be done to patients by removing this safe and effective technology from the US market. Please forward your comments to the FDA via the public docket as outlined in the Federal Register in the Electronic or Written Submissions section on page 48062.
The following links will lead you to the Monday, August 8, 2011 Federal Register notice, a Fact Sheet EPI prepared to assist in breaking down the rule making process and the validity of FDA assertions and for background information, we are providing a history of the arbitrary and capricious regulatory handling of CES by the FDA in the last 30 years and the last link is to Dr. Kathy Platoni’s expert opinion letter in response to the Proposed Ruling. The EPI Team is embarrassed that our government could produce such a misguided document under the guise of protecting public health. We pray that our community of support will be able to save CES in the USA! Please act now. We have until November 7, 2011 to be heard.
Please contact me or your Alpha-Stim Team member should you wish to discuss this further or have any questions or concerns.
Tracey B. Kirsch
President, Electromedical Products International, Inc.