FDA Won’t Pull Punches under Hamburg

Newly minted FDA Commissioner Margaret Hamburg has pledged to toughen up the agency’s enforcement practices, according to The New York Times [1].

[2]Although her language wasn’t exactly emphatic – she told reporters, “Under my leadership, we’ll see a somewhat more aggressive posture with respect to enforcement,” – there is little doubt Hamburg will lead an FDA more vigilant and less lenient than her most recent predecessors.

Time and time again, whether it’s foodstuffs, drugs, or medical devices, the FDA has come under scrutiny for failing to prevent products from imperiling citizens. Sometimes, the failures have been borne of a lack of political will, or of camaraderie with regulated businesses. Other times, FDA has lacked the resources to adequately monitor an increasingly complex supply chain. Sometimes, it’s been a basic lack of authority: FDA can’t order the recall of dangerous drugs or foods in most cases.

Hamburg’s words are already coming into fruition. The New York Times also reported [3]today that the FDA is warning [4]consumers to discontinue the use of Zicam, a popular nasal gel:

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.” 

So complaints of anosmia filtered into FDA throughout the Bush administration. Meanwhile, Matrixx was withholding from FDA the complaints it had received – more than 800, according to the Times. While they did nothing in a decade, Hamburg took action after only about three weeks on the job.

As mentioned above, FDA can’t order Matrixx to pull Zicam from store shelves. But the warning is a good precautionary step taken in the face of an apparent health risk; and it is a strong indicator that the agency is looking out for consumers first.

Image by Flickr user Dimmerswitch [5], used under a Creative Commons license.