INSIGHT REPORT
Vol 3  #6 
June 2000

INSIGHT REPORT

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Warning Letter Review

The FDA investigation branch has been referred to as the "EYES AND EARS" of the Agency. The investigators are supposed to go into the field and use their training to gather evidence by what they see and by listening what is told to them.

The FDA is always on the look out for violations and now the FDA has more places to look. It used to be that the FDA would look at newspapers and magazines to see what was being promoted to the public. Now the FDA looks at medical journals and makes visits to medical conferences.

But, the newest method of industry scrutiny is the INTERNET. This media, as anyone who cruises the Internet knows, is a wide-open arena of promotions and information. Some of this information is very valid and valuable.

Others, well as the saying goes, "Buyer Beware."

One of the major problems with Internet advertising and promotions, whether directly to the consumer or to the financial community through a company website, is that since the internet has no boundaries, promoting a product to Europe or Asia, may not have the same stipulations and requirements as one that is promoted to the USA market.

This could lead a company down a very difficult path when they have to face the US FDA concerning device or drug claim that may not have been approved.

Over the past year there have been several FDA Warning Letters as a result of unsubstantiated claims that the FDA found via their own search or was reported to them from consumers or more likely competitors. Some of these where found in medical journals and the Internet.

In April 2000, a Canadian company was issued a Warning Letter, which notified the company, Internet Birthcontrol.com, Inc. that they were soliciting the citizens of the United States to purchase various uncleared medical devices. The FDA's letter goes on to say, "For example, many of the devices used to prevent pregnancy and disease transmission, which you offer for sale on your Internet site, http://www.birthcontrol.com, require marketing clearance and may not be legally marketed in the US without such clearance."

The FDA's jurisdiction over this foreign company is limited to blocking the entry of their products at the border. This is very difficult to do especially if the products are shipped in small quantities directly to the consumer.

The FDA goes on to say, "We are taking steps to warn our citizens that these devices have not been cleared for marketing in this country and may not be legally imported."

There is not much more that the FDA could do to stop this company from operating their website or taking action against the corporate officers if they continue to take orders and ship products to the USA.

Recently, I learned that a Canadian company that had been promoting their products via magazines, was shipping their products via cars over the border and then mailing the products from the US. It took the FDA a long time to catch up with this operation.

In another website review, Medtronic was hit with a warning letter in May of this year. It appeared that the FDA's review of their website indicated that there were a number of significant inappropriate representations pertaining to the company's Activa(r) Tremor Control System. The FDA stated that, "Your website makes claims that "people with bilateral tremor can have two systems implanted, one for each affected side." This is in direct contradiction to the language describing your product's approved intended use..."

The warning letter goes on to review several other concerns that the FDA had on the promotion and labeling of the product that were in contradiction with the approved labeling. The FDA warned the company that if they did not take the appropriate corrective actions it might result in FDA's initiating regulatory action without further notice. These actions include, but would not be limited to, seizure, injunction and/or civil money penalties.

The FDA's reach into the medical community is very long as we might expect. In a March 2000 Warning Letter to Interpore Cross International, the FDA's review of an advertisement in the Journal of the American Academy of Orthopedic Surgeons.

In this case, the FDA interpreted an advertisement that represented the company's BonePlast(tm) product, one for which the company did not have FDA approval, inferring that the product could be injected directly into bony void or gap. The FDA felt that the advertisement pictorially represented this material being extruded through a syringe into a void used to spell the name of the product. This representation and the caption "Injectable, Moldable, Versatile - BonePlast(tm) is a representation that practitioners may inject Boneplast from its liquid or paste state directly into a bony void or gap." The text included with the picture made similar representations.

The Warning Letter goes on to define the FDA's regulations, at 21CFR 801.4 provide that the term "intended uses" of a device refers to the objective intent of the persons legally responsible for the labeling of a device. That intent may be shown by labeling claims or advertising matter or oral or written statements by such persons or their representatives.

The FDA states, "The specific violations in this letter may represent practices used in other promotional or advertising material used by your firm. You are responsible for investigating and reviewing these materials to ensure compliance with applicable regulations."

As you could see from these examples, the FDA is out there watching what companies are doing. To be sure not every exaggerated claim is either spotted by the agency or reported to them by a consumer or a competitor. However, if the FDA does find such a problem they are prepared to follow up, make the appropriate warnings and if not corrected take the required legal actions against the company.

How can a company avoid such labeling or promotion problems? From my experience, in many companies the marketing department is not under any regulatory review. This is where many of the problems occur. The over-zealous marketing department, excited to promote a product to its utmost potential without regard for the regulatory requirements, is the formula for potential problems.

Companies should review how product promotions and advertising are written, reviewed and released. A regulatory overview is critical to companies to assure that problems as described above are avoided. If you are marketing via the Internet, and this marketing is worldwide, you should include any and all statements needed to make clear that certain products are not FDA cleared/approved and therefore not available in the USA.

(Please note that these examples were taken directly from warning letters issued by the FDA. These companies had not been contacted for a statement. There is no representation as to if and what corrective actions were already taken by the company to correct these violations. These companies may have already made the appropriate actions to correct these problems.)

Next Month’s Insight Report –

         The next Insight Report Vol. 3 #6

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