Unapproved Device Claims Garner CDRH Warning Letters for Three Companies

Demonstrating its continued aggressive approach to violative device promotional activity, the FDA's Center for Devices and Radiological Health (CDRH) recently issued three Warning Letters to companies for allegedly promoting their devices for unapproved uses in print publications, detailing pieces and on the Internet.

The total number of Warning Letters issued thus far in calendar year 2000 for device promotion violations now stands at 12, with indications pointing at a possible record year for this area of FDA enforcement.

Biofeedback Measurement

In a May 19 Warning Letter to Phazx Systems Inc., CDRH charged that the company made several violative promotional claims concerning its BodyScan 2010 and VLD-100 in a promotional brochure and on its Website (www.phazx.com). Both devices received premarket notification (510(k)) clearance for the measurement of galvanic skin resistance for biofeedback information. However, the Colorado Springs, Co.-based company allegedly promoted the devices for unapproved diagnostic and disease-treatment purposes.

For example, the "Testimonials" section of the Web site allegedly claimed that the use of the BodyScan prevented a five-year old boy from having extensive surgery because it detected a severe bacterial imbalance that could be treated with nutritional therapy. A number of other similarly violative testimonials also allegedly appeared on the Web site, according to CDRH.

The Web site and promotional brochure also allegedly promoted the BodyScan for detecting the elevation of amino acids, bacteria, DNA, hormones and viruses as a means of identifying and measuring the most promising treatment course.

Further, CDRH found that a newspaper article had wrongfully stated that Phazx provides training and certification on the use of the BodyScan and claimed that 700 healthcare practitioners who use the device share their data and research on the Phazx Web site.

Both the BodyScan and the VLD-100 are adulterated because they are Class III devices without approved premarket approval (PMA) applications or approved investigational device exemptions (IDEs), the Warning Letter states. The devices also are misbranded because the alleged promotional violations served to alter their intended use, according to CDRH.

CDRH further concluded that the devices are misbranded because both the brochure and the Web site misleadingly used the company's FDA device establishment registration number to convey an impression of official agency approval. "Registration of an establishment is just one requirement that must be met, but it is also not a determination of FDA approval as to the status of any device," the Warning Letter states.

The FDA ordered Phazx to take prompt corrective action and to notify the agency in writing of its efforts. Failure to respond could result in further regulatory action without notice, including seizure, injunction and/or civil penalties, CDRH warned.

Phazx did not return phone calls made by the Monthly Bulletin.

Dental Device

In a May 10 Warning Letter to the Paragon Implant Co., CDRH charged that the Encino, Calif.-based company made several unapproved promotional claims on the Internet regarding its Paragon Swiss Plus Implant System, an implantable dental device designed to restore the ability to chew.

Specifically, the FDA alleged that two of the company's Web sites (www.paragon-implant.com and www.straumann-clone.com) claimed that the Paragon System and its components were compatible and/or interchangeable with Straumann's ITI Dental Implant System and its components.

According to the Warning Letter, claims of compatibility or interchangeability represent a major modification in intended use and, therefore, require the submission of a new premarket notification (510(k)). The Paragon System is adulterated under Section 501(f)(1)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act) because it is a Class III device without an approved PMA or IDE, the Warning Letter states. Further, the device is misbranded because the FDA was not notified of the change in the device's intended use and because it was not found to be substantially equivalent to a predicate device.

CDRH ordered Paragon to submit within 15 days a written plan for correcting the noted violations, including a description of all the steps taken to address misleading information currently in the marketplace and actions for preventing similar future violations.

Paragon did not return calls for comment.

Intraocular Lens

Allergan Inc. allegedly made a number of unapproved and unsubstantiated promotional claims regarding its AMO PhacoFlex II Intraocular Lens (IOL) in several print media, according to an April 19 CDRH Warning Letter to the Irvine, Calif.-based company.

The FDA approved the implantable device for visual correction of aphakia in individuals 60 years of age or older for whom cataractous lenses were removed by extracapsular cataract extraction or phacoemulsification. However, CDRH charged that Allergan claimed in several promotional pieces that its lens could be inserted through smaller unenlarged incisions than that for which it was approved.

Further, the company allegedly went beyond its approval in an ad that appeared in the June 15, 1999, edition of Ocular Surgery News to claim that the AMO PhacoFlex provided such benefits as "no induced astigmatism, long-term wound stability and reduced complications associated with wound enlargement." According to CDRH, Allergan submitted a PMA supplement for the claims, but failed to respond to an FDA deficiency letter on the matter. Subsequently, the agency considered the supplement withdrawn.

CDRH also cited the company for prematurely making comparative claims regarding its SLM-2W silicone IOLs and polymethylmethacrylate IOLs in a June 3, 1999, "Dear Doctor" letter to Eye Associates Northwest; the FDA did not approve the comparative claims until July 2, 1999. Additionally, the "Dear Doctor" letter allegedly promoted Allergan's IOL as the "gold standard" in foldable lenses, causing less inflammation than other competing products. Both claims have not been approved by the agency, the Warning Letter states.

Additionally, CDRH charged that Allergan inappropriately compared the AMO PhacoFlex to other IOLs in a "Dear Doctor" letter mailed to ophthalmic surgeons in October 1999, a two-page advertisement in the Nov. 1, 1999, edition of Ocular Surgery News and a handout obtained at the Oct. 24, 1999, American Academy of Ophthalmology meeting in Orlando, Fla.

Such claims render the device adulterated and misbranded under sections 501(f)(1)(B) and 502(o) of the FD&C Act because they exceed the scope of the product's FDA approval, the letter states. The device also is misbranded under 21 CFR §801.6 because false and misleading representations allegedly were made about another device in the promotional materials.

The FDA ordered Allergan to take prompt corrective action and to notify the agency in writing of the specific steps taken to correct the alleged violations. Further, CDRH instructed the company to adhere to the conditions of the PMA approval for the AMO PhacoFlex  a restricted device  by including in all ads and other descriptive printed material a brief statement of the intended uses of the device, including relevant warnings, precautions, side effects and contraindications.

"Simply referring readers to the product labeling is not a substitute for the required information," the Warning Letter states.

Allergan Spokesman Ira Haskell said that the company is "working with [the FDA] to resolve" the alleged violations, but noted that the FDA has acknowledged it made a mistake in citing Allergan for claiming that it is the only company approved for posterior capsule opacification (PCO) value claims. "The PCO claim is true, and they acknowledged that to us," Haskell said.