CDRH Web promo letters.

Issued in a flurry, despite fact FDA has no guidance

Dear Reader,

The Center for Devices appears to have gained a newfound fondness for citing device manufacturers about alleged off-label promotion of products on the Internet.

In the past two weeks, the Promotion and Ad-vertising Staff in the Center's Office of Compliance has landed hard on promotion, issuing six warning letters, four of which concern Web-site presentations that the agency said overstepped the limits of the clearance for each product's 510(k).

Another letter slapped a firm for adding claims not covered by a premarket approval (PMA) applica-tion and one more said a journal ad exceeded a 510(k) clearance (See pages 3-5).

That brings the total to seven for device adver-tising warning letters so far this year. In comparison, WLB records show that of nine device advertising warning letters issued during 1998, only two cited Internet promotions.

Asked what might have triggered the onslaught, promotion staff director Byron Tart described it as coincidental.

The last time CDRH hit the industry for Internet-related promotions was in January when three firms got warning letters:

[middle dot] Alcon Labs, for letters touting an uncleared claim in-volving its AcrySof intraocular lenses and not responding to a letter addressing violative claims on its Web site (Doc. 7266W, Feb. 8 issue, page 6). FDA initially addressed these issues in an untitled letter (Doc. 7564, page 7).

[middle dot] Sybaritic, for making cellulite-reduction claims for the GX-99 Massage Therapy System on its Web site, de-spite promises to the contrary (Doc. 7273W, Feb. 8 issue, page 7).

[middle dot] Hon-Tech Foundation for Medical Technology, for promoting uncleared claims for the Itchstopper on its Web site (Doc. 7302W, Feb. 22 issue, page 4).

However, records obtained by Warning Letter Bulletin show Tart's group has been using the "untitled letter" a great deal to ward companies away from using the Internet for off-label promotion.

Of 82 untitled letters that CDRH issued from April 1998 through February, 23 hammered on Web sites, the documents show.

In comparison, Internet citations for drugs are relatively rare. Of 41 untitled letters released this year by the Center for Drugs Division of Drug Marketing, Advertising and Communications, only two referred to Web promotion, a WLB analysis shows.

The lone DDMAC warning letter released this year - to Novartis in January - addressed a direct-to-consumer (DTC) TV ad, not an Internet promotion (Doc. 7256W, Feb. 8 issue, page 3).

It is ironic that CDRH would take a harder line on Internet-related promotion because FDA's authority to regulate drug advertising is more solid than its abili-ty to regulate device advertising.

Usually, Tart's staff does not cite "advertising" for devices unless they are PMA-approved or restricted devices such as hearing aids. Attorneys maintain that FDA only has the authority to regulate device adver-tising if the product is restricted, though FDA uses restrictions as conditions of PMA approval.

However, the Center, at least, has interpreted the Internet and other marketing materials as "labeling," for which CDRH has clear authority, and has used the misbranding and adulteration provisions of the law as justification for getting firms to revise their promotions.

One of the letters, to Alcon (Doc. 7563W, page 7) referenced the 1948 court case of Kordel v. United States, which the agency uses as a basis for treating materials as labeling even when they do not accompany the product.

In 1997, FDA was supposed to have issued guidance to industry about what can and cannot be said about drugs and devices on the Internet, but no such document has appeared. There has been speculation that the guidance is being held up by a government-wide effort to determine how the Internet - as a whole - should be regulated.

In this issue, WLB begins publishing abstracts of the 1998 device untitled letters, divided by product category. Look for more in future issues.

Sincerely,

The Editors

P.S. - The 82 CDRH advertising untitled letters issued by CDRH from April 1998 through February are available from RECORD-RETRIEVE for a special package rate of $200.