To the Editor:
The Food and Drug Administration thanks you for emphasizing our continued efforts to protect the public and raising consumersâ€™ awareness that certain drugs are marketed without F.D.A. approval. In June 2006, the F.D.A. announced its renewed emphasis on solving the problem that many drugs lack F.D.A. approval, often because they were introduced into the market long before the F.D.A. had its current regulatory authority.
To deal with the unapproved drugs that remain in use, we give highest priority to drugs that have safety concerns, lack evidence of effectiveness or are health frauds. This approach is carried out without imposing undue burdens on health care and is applied uniformly against all companies, large and small, that market these drugs.
The F.D.A. is committed to proactive action to assist companies with finding opportunities to legally market their products. As part of this commitment, the F.D.A. appointed an unapproved drugs coordinator and conducted a full-day workshop in January 2007 to educate companies about the drug approval process, the over-the-counter monograph process and user fee waivers. Our unapproved drugs coordinator consults frequently with companies, and many of them have begun the approval process for their products.
Some refer to these unapproved marketed drugs as â€œlegacy drugs.â€ A legacy is not a substitute for drug approval. Individual experience, anecdotal evidence and marketing history are insufficient bases for concluding that a drug is safe and effective. In fact, experience demonstrates that unapproved drugs are often unsafe, ineffective, inappropriately labeled and poorly manufactured. This is not the legacy that we want for our families.
I, and the entire F.D.A., remain committed to ensuring that safe and effective drugs are available to protect and promote the health of the American people.
Andrew C. Von Eschenbach, M.D.
Commissioner of Food and Drugs, Food and Drug Administration
Washington, Oct. 22, 2007