Modules and patents and grants—oh my!

March 14, 2001

I’m from the old school. If news doesn’t have a hard edge, it’s fluff. Lately, there has been a lot of fluff floating around.From my point of view, hard news is when a device clears the FDA or a company develops a new technology. Today,

I’m from the old school. If news doesn’t have a hard edge, it’s fluff. Lately, there has been a lot of fluff floating around.

From my point of view, hard news is when a device clears the FDA or a company develops a new technology. Today, some companies would have us believe milestones in this process are worthy of note. Examples of such ersatz news are the submission of an FDA application or the award of a patent or grant.

There are a few exceptions to this rule, one of which appears in this issue (our cover story on the ITC). For the most part, however, announcements of a new patent, a grant totaling several hundred thousand dollars, or the acceptance by the FDA of an application “module” are all signs that the companies making such proclamations have little else to say.

Of these three, FDA modules really get my goat. I cringe every time a press release crosses my desk noting that a new module has been completed.

This practice is especially annoying when the company states that the module has been “accepted” by the FDA. This word is ripe for misinterpretation. All it really means is that FDA staffers, after determining all the blanks were filled and pages attached, have put the application at the bottom of the “in” pile. No judgment has been passed regarding the quality of the data or the veracity of the claims. Decisions on these matters are months or years away.

The FDA started the practice of “accepting” submissions so companies could be alerted to technical oversights and deficiencies early on. Immediately examining the application for omissions speeds the review process, optimizes FDA efforts, and allows industry to correct problems quickly.

Some companies, however, use carefully crafted language to get more credit than they deserve. Doing so denigrates a noble process, one that creates devices that save lives. It diminishes the accomplishments of companies that deserve credit for real accomplishments.

In short, if you can’t say something meaningful, don’t say anything at all.