Inspections, Compliance, Enforcement, and Criminal Investigations
Rapid Recovery Health Services Inc. Company Response Letter #2
101 Eisenhower Parkway, Roseland, New Jersey 07068
Tel: (973) 228-5700
Fax: (973) 228-7852
Direct Dial: (973) 403-3132
Direct Fax: (973) 618-5532
April 20, 2005
CERTIFIED MAIL RETURN RECEIPT REQUESTED
VIA FEDERAL EXPRESS
William MacFarland, Chief
Orthopedic, Physical Medicine &
Anesthesiology Devices Branch HFZ-343
Division of Enforcement B, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850
Re: Rapid Recovery Health Services, Inc.
Our File No.: WAR 121 -219992
Dear Mr. MacFarland:
On behalf of our client, Rapid Recovery Health Services, Inc. (Rapid Recovery), we are writing in response to your Warning Letter dated March 7, 2005, which referenced our client's website, www.rapidrecoveryinc com. Note that this letter expands on our client's response letter, dated March 23, 2005 (enclosed hereto as Exhibit A). Specifically, you stated that Rapid Recovery's website was not compliant with current Food and Drug Administration (FDA) regulations with respect to the promotion of extracorporeal shockwave therapy (ESWT) through the use of the Sonocur® and Epos™ Ultra medical devices. As such, we want to reiterate that upon receipt of your letter, our client immediately initiated corrective action steps as detailed below.
Rapid Recovery has advised us that as of the date of your letter, it is was under the belief that the information on its website related to ESWT in no way promoted or introduced into interstate commerce the Sonocur® and Epos™ Ultra devices for unapproved indications, which in turn would render them adulterated and/or misbranded. However, since we have been retained as counsel, our client has been informed of the applicable laws and regulations related to the promotion and marketing of medical devices and has committed itself to become compliant and remain compliant with said laws and regulations on an ongoing basis.
II. Rapid Recovery's Corrective Action Steps
Upon receipt of your letter, our client reviewed its website and immediately initiated the following corrective action steps. First, Rapid Recovery retained our firm to provide counsel related to the promotion and marketing of ESWT as well as applicable medical devices. Such counseling will include Rapid Recovery's website as well as other modes of communication with health care providers and consumers. To the best of our knowledge, Rapid Recovery has advised us as to all of its current marketing activities with respect to ESWT and will notify us of all future marketing proposals prior to finalization to ensure compliance with applicable FDA regulations.
Second, since receipt of your letter, we have been in constant communication with Rapid Recovery regarding modifications to its website necessary to address the items stated in your letter and ensure compliance with applicable laws and regulations. In addition, our client has reviewed and revised its website based upon our recommendations as set forth below (copies of current screenprints are enclosed hereto as Exhibit B) . Further, the following items have been added to the website or have otherwise been modified including, but not limited to:
1. References to unapproved indications of the Sonocor© and/or the EposTM Ultra have been deleted.
(a) The Sonocur® is referenced only as indicated in the FDA's Approval Letter, issued July 19, 2002. Specifically, the website has been modified to reflect that the Sonocur is approved solely for the treatment of chronic lateral epicondylitis (commonly referred to as tennis elbow) for patients with symptoms of chronic lateral epicondylitis for six (6) months or more and a history of unsuccessful conservative treatments (see http://www.fda.gov/cdrh/pdf/P010039a pdf; enclosed hereto as Exhibit C).
(b) The Epos™ Ultra is referenced only as indicated in the FDA's Approval Letter, issued January 15, 2002. Specifically, the website has been modified to reflect that the Epos™ Ultra is approved solely for the treatment of chronic plantar fasciitis for patients with symptoms of plantar fasciitis for six (6) months or more and a history of unsuccessful conservative therapy (see http://www.fda.gov/cdrh/pdf/P000048a.pdf; enclosed hereto as Exhibit D).
2. The website has been modified to clearly differentiate between the FDA- approved indications of the Sonocur® and the Epos™ Ultra. The website indicates, as applicable, that:
(a) Chronic lateral epicondylitis (tennis elbow) is treated solely through the use of the Sonocur ESWT device; and
(b) Chronic plantar fasciitis is treated solely through the use of the EposTM Ultra ESWT device.
3. The list of frequently asked questions (FAQ) has been modified to comply with each device's corresponding labeling, as follows :
(a) Information from the Sonocur® corresponding label was previously included in the FAQ list. However, the list has been updated to more closely reflect the Sonocur©'s corresponding label (see http://www.fda.gov/cdrh/pdf/P010039a pdf;; enclosed hereto as Exhibit E).
(b) The FAQ list has been updated to include information related to the EposTM Ultra and references information from its corresponding label (see http://www.fda.gov/cdrh/pdf/P000048a.pdf; enclosed hereto as Exhibit F).
4 . A section was added to the Rapid Recovery for Patients section related to treatment of chronic plantar fasciitis with the Sonocur® and Epos™ Ultra.
5. The link to the information sheet, as well as the information sheet, has been deleted in its entirety.
III. Rapid Recovery's Plan to Prevent Future Noncompliance
As stated previously, Rapid Recovery has retained this firm to provide counsel related to the promotion and marketing of ESWT as well as the Sonocur, Epos™ Ultra and any other ESWT medical devices contemplated for future purchase. Such counseling will include Rapid Recovery's website as well as other modes of communication with health care providers and consumers. In addition, our client has committed to notify us as to any and all future ESWT promotional and/or marketing activities prior to finalization to ensure compliance with applicable FDA regulations . Specifically related to its website, our client plans to implement the following elements including, but not limited to:
1. Promotion and Marketing. A person or persons will be appointed by the chief executive officer who will have the day-to-day responsibility to ensure the website's compliance with applicable laws and regulations . Such person's duties shall include, but not be limited to, the review and assessment of proposed revisions, updates or any other modification to the website as well as the approval or denial of such revisions, updates or modifications based upon corporate policy as well as applicable laws and regulations' ; monitoring and periodic audits of the website; and good faith inquiries into any allegations set forth through the below-referenced disclosure mechanism.
2. Training and education. All employees directly related to the promotion and/or marketing of ESWT and/or the Sonocur® and Epos™ Ultra devises including, but not limited to, the person or persons responsible for promotion and marketing as set forth above, the person(s) responsible for inputting updates and/or other modifications to the website, as well as public relations, shall receive education and training related to the approved indications of the Sonocur® and the Epos™ Ultra devices, corresponding policies and procedures and all applicable laws and regulations. Training shall be provided by a person or persons knowledgeable and experienced in the promotion and marketing of medical devices.
3. Effective lines of communication. A mechanism (i .e., drop box and/or toll-free number) to be decided later, will be implemented, which will enable employees and/or other individuals to disclose identified issues or potential problems related to the promotion and/or marketing of ESWT and/or related devices. Such mechanism shall ensure anonymity and confidentiality and emphasize a nonretribution, nonretaliation policy.
4. Auditing and monitoring. The website shall undergo internal monitoring as well as periodic internal auditing (at least monthly in the initial period and subsequently at least quarterly).
5. Enforcement of policies and procedures. Our client will create and implement guidelines enforcing policies and procedures.
( Note that any revision, update, or any other modification to our client's website will be reviewed pursuant to its Reviewing and Approving Website Modifications Policy.)
6. Response to detected problems. Our client will respond promptly to detected problems and undertake corrective action, as necessary.
7. Policies and procedures. Written policies and procedures, which will incorporate the foregoing, will follow under separate cover.
We believe that these corrective action steps will address your concerns regarding our client's current and future compliance with FDA regulations. Please do not hesitate to contact me should you need further information or clarification regarding the foregoing.
Mark E. Manigan