[Commentary by Jim Dickinson*] With newspaper circulations tumbling throughout the nation, and TV news viewership also in decline, now seems an odd time for FDA to adopt a new policy of serving regulatory notice on industry via news releases.
The policy, for multiple firms with same violation, was first enunciated by Office of Enforcement director David K. Elder in a 6/7 Wall Street Journal article and then defended in unclear terms by associate commissioner for public affairs Julie Zawisza in a report here by consulting editor John Scharmann.
Something needs to be understood about news dissemination. First, the news media are not regulated by FDA and therefore its news releases cannot be assured of even being published, much less reaching target companies.
Second, even if published and read, where is the legal proof the notice was indeed received by the responsible parties?
FDA appears to be operating on a premise that proof of receipt of notice, traditionally shown in a signed Certified Mail receipt or similar instrument, or in a court motion’s “Certificate of Service,” is not legally necessary to begin an enforcement action against a company.
a case for ...
This may be the case for the agency’s new policy:Under the assumption that, initially, any given enforcement action need not be based on written preparations that are legally sufficient to survive judicial scrutiny the agency can proceed optimistically on a PR-based “Plan A” type of approach, reserving traditional, formal notice for a “Plan B” scenario if a company balks.
In all probability, “Plan B” won’t be required, because the overwhelming majority of enforcement actions don’t end up in court. The company automatically capitulates to whatever FDA wants.
Thus, FDA may be thinking, informal notice by news release is sufficient, and may actually improve our prospects of achieving voluntary compliance by injecting the intimidating element of publicity right off the bat, before the company has had a chance to think.
This approach, as Elder and Zawisza have implied, may be best reserved for mass actions involving many companies, where bureaucratic follow-up resources are most taxed when taken on an individualized basis. A single company’s rogue behavior may not suit this approach.
a case against ...On the other hand, FDA’s new policy may be counterproductive in practice for several reasons.
First, even if an FDA enforcement action doesn’t end up in court, the principle of prior notice is a matter of simple fairness, understood even in pre-school. FDA should not assume that its news releases reach all affected parties. With fewer people reading newspapers and watching TV news (where most FDA enforcement actions would not normally be reported anyway), alternative media would need to be tapped, and they’re less trackable than old media.
Second, the policy’s success depends upon media cooperation, which should not be taken for granted. Media managers do not like being used as an arm of government and could either just not go along, or could turn FDA’s policy against it by running stories questioning the policy’s propriety on First Amendment or ethical grounds. Shorthand: FDA do your own dirty work.
Third, FDA reliance on unverifiable communications to serve notice on noncompliant firms could result in some, many or all of them not being noticed, thereby providing them with a plausible excuse for proceeding as before and giving FDA a task that is larger rather than smaller.
My bottom line: If this is FDA’s new policy, it seems both legally and ethically unsound. News releases should be additive to direct FDA prior notice, never a substitute.
*Editor, Dickinson’s FDA Webview.
