300 Lawsuits Against Zicam, Still FDA didn’t Care. Now They Woken up to Act Aggressively For Public Health Care

There is a new sheriff in town or maybe a posse. The new FDA Commissioner, Margaret Hamburg and deputy, Joshua Sharfstein, are in place. Recently confirmed, Hamburg says the FDA will now act aggressively in the area of public health. The FDA has rumpled feathers already by re-considering a knee device used in surgery. Several FDA staff doctors are questioning its value. The FDA may re-review it. This is an un-heard of action. In addition, they moved quickly to recall tainted pistachios in California. They have sent out strong letters to drug companies warning them about the honesty of Web marketing and claims they have made.

J. Corbett Dooren in THE WALL STREET JOURNAL (June 17) cites the many new actions and the worries of some observers about a too aggressive FDA. They may act to slow new methodologies from coming out for needed treatments. A fine line again is drawn between rapid access to technology and drugs versus patient safety. How can the FDA assure both?

Under a new law passed in 2007, the FDA now has authority over OTC drug safety as well. Drug makers must now report to the FDA all adverse side effects of their OTC supplements. This was not the case before. Under this law, the FDA moved to have MATRIXX INITIATIVES INC. recall its nasal cold remedy ZICAM. Prior to 2007, there were 300 lawsuits over Zicam and loss of the sense of smell. These cases were not reported to the FDA as no law existed requiring such an action. People claimed that the zinc based nasal gel destroyed the smell sense. Evidence exists since 1930 that zinc could alter or destroy smell when applied to the nose. Moreover, the FDA says that zinc supplements are not effective in altering the duration or severity of a cold. Earlier this year, FDA officials inspected Zicam facilities and found more cases—but these had not been reported as they should have been. The FDA acted. Zicam was recalled. However, OTC supplements still do not require preapproval for distribution. It appears that something must go wrong and someone must be hurt before the FDA can act in this area.

The company has recalled its product but says they are still confident that it is safe. The FDA warned that consumers should stop using the products sold as: 1) Zicam Cold Remedy Nasal Gel or as 2) Swabs.