[Report by John Scharmann*] Has FDA Office of Enforcement director David Elder added a new industry warning tool to his armory?
It was reported in a Wall Street Journal article 6/7 that the decline in the number of Warning Letters in the last 10 years should not be used as a measure of FDA’s enforcement stance.
Elder is reported to have said that the decline in Warning Letters came as the FDA also changed its enforcement approach. Rather than sending out individual Warning Letters to separate companies with a similar violation, FDA now alerts the industry via press releases and other forms of communication when it notices problems.
In an effort to confirm this change in policy, I sent Elder an e-mail 6/10 stating that I wished to talk with him. Elder’s response to me was that he had referred my request to FDA’s Press Office in accordance with standing policy.
The same day, I sent the following questions to Stephanie Kwisnek in that office:
- I would like some examples of where press releases have been used in place of Warning Letters to warn specific firms of a problem FDA has identified, as suggested in the WSJ article attributed to Elder. Also examples of where the use of press releases has resulted in “more widespread” compliance than an individual letter?
- With this alleged increase in compliance, how does Elder explain the increase of recalls with the decrease in Warning Letters and the use of press releases?
- Where does Elder spell out in an FDA public notice this change in FDA enforcement approach?
Does Elder’s announced change in FDA’s enforcement policy make Dickinson’s FDA Webview a part of this new enforcement process for FDA? We routinely post FDA press releases and if one of our subscribers has a problem alluded to in the press release and reads this article does this mean he has now received official notice from FDA?
To me this is a real stretch of the prior notice policy — or does this just give industry one more bit of the apple before the formal warning process kicks in?
On 7/8 I received a reply from FDA associate commissioner for public affairs Julie Zawisza. This essentially avoided direct answers to my questions and left dangling the issue of whether FDA thinks press releases can legally serve as adequate notice to a company, in lieu of an actual Warning Letter. There may have been a reluctance on the agency’s part to directly contradict such an esteemed authority as the Wall Street Journal, on the accuracy of its reporting! Readers can draw their own conclusions by following this link.
I would draw our readers’ attention to several statements in Julie’s reply — 1. Warning Letters and Recalls are not regulatory actions. Seizures, Injunctions and Prosecutions are regulatory actions. 2. If you look at FDA Enforcement Story data over the past several years you will see that there has been no real improvement in industry’s compliance status, as Julie claims.
However, if you use recalls as a benchmark, the number of recalls have increased about 30% over the past 10 years. Products are recalled because they are in violation of FDA statutes. Meanwhile, Warning Letter numbers have decreased about 50% over the same time frame.
It would appear that FDA sees no causal linkage between Warning Letters and recalls, and that press releases may now serve as sufficient notice of a warning to a firm.
