Home The Book Dr Articles Products Message Boards Journal Articles Search Our Surveys Surgery ESWT Dr Messages Find Good Drs video

FDA & off-label marketing

Posted by john on 4/26/05 at 13:30 (173765)

Here is a letter from the FDA website warning a vendor about off-label marketing. It looks like the FDA is serious about off-label marketing of ESWT.


MAR 7 2005



Mr. Scott Warantz
Rapid Recovery Health Services Inc.
30 Hopper Street
Westbury, New York 11590

Dear Mr. Warantz:

The Food and Drug Administration (FDA) has reviewed information from you website,www.rapidrecoveryinc.com, relating to extracorporeal shockwave therapy (ESWT) devices. The website promotes the SonocurŪ and the Epos Ultra for the relief of pain in the elbow, hand/wrist, shoulder, and knee/heel, as well as for other tendon-associated pains. The website indicates that your company will provide the Sonocur or the Epos Ultra to a practitioner's office, along with a technician trained to use the device . The technician will then administer the device on patient(s) under the practitioner's supervision.

Under the Federal Food, Drug, and Cosmetic Act (the Act), the Sonocur and the Epos Ultra are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or to affect the structure or a function of the body (section 201(h) of the Act, 21 U.S.C.321(h)). The law requires that certain devices be approved or cleared by FDA before they may be marketed or offered for sale . This helps to ensure that these devices are either safe and effective or substantially equivalent to other devices already legally marketed in this country.

In a letter dated November 26, 2003, we advised you that the Sonocur was approved only for the treatment of chronic lateral epicondylitis in patients with symptoms for at least six months and a history of unsuccessful conservative treatments . We also advised you that the approved indications for use did not include treatment of pain the hand/wrist, shoulder, or knee/heel (plantar fasciitis), or other tendon-related problems, like those described on your website. The Epos Ultra has been approved only for the treatment of chronic plantar fasciitis in patients with symptoms for at least six months and a history of unsuccessful conservative treatments . It has not been approved for treatment of pain in the hand/wrist, shoulder, or elbow, or for other tendon-related pain. PMA approval for the treatment of pain in the aforementioned areas is required before the devices may be marketed or offered for sale for those uses.

Your promotion and introduction into interstate commerce of the Sonocur and Epos Ultra devices for these unapproved indications renders them adulterated under section 501(f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).

There are many FDA requirements pertaining to the manufacture, distribution, and marketing of devices. This letter does not address all of the obligations you have under the law. You may obtain general information about FDA's requirements applicable to devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at (800) 638-2041 or through the Internet at http://www.fda.gov .

You should know that these serious violations of the law may result in the FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. FDA may assess civil money penalties against you as an individual, and against Rapid Recovery Inc., for violations of Section 301(a) of the Act, i.e., the introduction or delivery for introduction into interstate commerce of any . . .device. . .that is adulterated or misbranded. Under Section 303(f)(1)(A) of the Act, FDA may impose civil money penalties of up to $15,000 on you as an individual for each violation of a requirement of the Act, up to a total of $1,000,000 per respondent for all violations.

Federal agencies are advised of all warning letters about devices so that they may take this information into account when considering the award of contracts. Also, no requests for Certificates for Export will be approved until the violations related to the subject device have been corrected.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Sonocur and Epos Ultra comply with each applicable requirement of the Act and FDA regulations.

You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to seizure, injunction, and or civil penalties.

Please provide this office in writing within fifteen (15) working days of receipt of this letter a report of the specific steps you have taken, or will take to comply with this request. We request that you notify this office in writing of the steps you are taking to correct the noted violations. We also ask that you explain how you plan to prevent this from happening again. Please address your response to:

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

If you have any questions, please contact Mr. Willam MacFarland at (240) 276-0120.

Sincerely yours,


Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health

Re: To John FDA & off-label marketing

Ralph on 4/26/05 at 15:05 (173770)

Haven't those same machines been promoted here for the same type of treatments?

I remember doctors posting that they have had good success
treating Achilles problems with ESWT and have recommended it for neruomas too.

From the letter you posted it would seem that it isn't a good idea to promote treatment of this kind here either.

Question though, didn't a machine did get approval for treating shoulders?

Re: To John FDA & off-label marketing

Ralph on 4/26/05 at 15:16 (173771)

You opened a big can of worms. Dr. Z, website mentions many of those same treatments that the letter says it can't promote. Hope Elliott is on vacation.

Re: To John FDA & off-label marketing

Ed Davis, DPM on 4/26/05 at 20:09 (173797)

Doctors have the right to introduce off label drugs and devices to patients but manufacturers and apparently companies that provision such devices cannot. Some will try to split hairs by stating that doctors are marketing such drugs and devices but every contact or word we utter can be construed as a form of marketing and the FDA has long recognized the position of doctors. Doctors have a relationship with patients that is presumably not to be violated. The internet opens a gray zone due to, again, every piece of advice we utter could concievably be construed by some as marketing. Either doctors can get online and answer questions or not. If we are to answer questions then we have to be complete and truthful in those answers. If we cannot discuss items that are not FDA approved (and there are lots of such items) then we would be giving incomplete or innaccurate advice and it is not the intent of the FDA to see that occur.

Ralph, I suspect that Dr. Z and ScottR may join in this discussion to give you their interpretation.

Re: To John FDA & off-label marketing

Ralph on 4/26/05 at 22:33 (173809)

Dr. Ed,
You are probably right, but did you look at the Rapid Recovery website.
They are a service provider. Dr. Z's Excellence Shock Wave Group is also service provider.

Rapid Recovery provides mobile service to physicians in several states, interstate commerce. Dr. Z's group provides mobile service to physicians in several states.

According to the letter Rapid Recovery is promoting the Sonocur and Espos for unapproved indications or Off Label usage.

Dr. Z's group isn't promoting Sonocur but it's promoting the Espos for the same type of treatments.

I'm not an FDA attorney or any attorney for that matter, but after reading that letter I think they are saying a company, ie an ESWT service provider like Rapid Recovery promoting one of these machines to doctors across state lines for unapproved usage is considered different from an individual doctor using his own ESWT machine off label in his own office.

Dr. Z's ESWT group may fall into the same catagory as Rapid Recovery.
The same might be true for that other large ESWT provider. I forget the name, but the one that didn't charge patients if their insurance didn't pay.

This Rapid Recovery sounds huge when compared to Dr. Z's group but are they all seen the same in the eyes of the FDA is the question I guess.

You can keep using your Sonocur off label just don't try to promote it for off label use to another doctor across state lines is what I take from that letter.

Take a look at that Rapid Recovery site. Look at their predictions for their market share. It's huge. Talk about competiton.

Re: To John FDA & off-label marketing

Ed Davis, DPM on 4/27/05 at 21:13 (173855)

Thank you. I assume that Dr. Z will post soon for further information.

Re: To John FDA & off-label marketing

elliott on 4/29/05 at 10:28 (173915)


If you read the letter carefully, the problem is not advertising services across state lines or for off-label use, but rather *marketing* the device to other *practitioners* under such conditions. Dr. Z's web site is not soliciting other doctors, only patients, so I think they're OK. I'm not sure if I'm feeling OK, defending Dr. Z and all. :-)

Re: To John FDA & off-label marketing

Ed Davis, DPM on 4/30/05 at 12:01 (173973)

Thank you. I was not sure if you were here during one protracted argument over exactly what consisted 'marketing' or not?