Advertisement
   << Issue   << Category        

Why the FDA Matters

Harold E. Cohen, RPh
Editor-in-Chief



3/20/2012

US Pharm. 2012;37(3):1.

As the 2012 Presidential campaigns continue to heat up, there seems to be no shortage of Americans who would like to see less government intervention in our lives. What I don’t hear is just how much less and exactly what services should be cut. I get the feeling that many people who are quick to criticize various government agencies’ programs are okay with their elimination as long as it doesn’t affect them personally. I think it goes without saying that our government could stand to undergo a close inspection of all its programs and cut or reduce those that do not benefit the majority of Americans. I do think, however, that there are many significant and worthwhile government agencies and programs that warrant investing in as well. One of those is the FDA.

As a health care professional, I see the FDA as having a formidable task to perform in keeping this country’s drug supply safe. While not perfect and often criticized for some of its more overzealous actions, I would rather the FDA be judicious in its decision-making than make hasty decisions that can have far-reaching negative health consequences. One only has to remember the horrific teratogenic side effects of the drug thalidomide, which was widely distributed as an “approved drug” in countries other than the U.S. in the late 1950s and early 1960s. Tragically more than 10,000 children in 46 countries where thousands of pregnant women took the drug to prevent nausea during pregnancy (among several other indications), were born with serious deformities. Thankfully, when the drug was presented for approval to the FDA here, the agency learned that the drug was never tested on pregnant animals and its approval was rejected, averting similar results that befell patients in other countries. Despite the FDA’s critics, there is a high assurance factor that every prescription drug submitted to the FDA for approval gets the same close scrutiny. I know that I sleep better at night knowing my prescription medication has gone through the FDA’s rigorous approval process.

As pharmaceuticals continue to evolve, the FDA will continue to be challenged by a plethora of other issues thrown its way. I am confident the agency will handle each situation with the same degree of professionalism it has for the past century.

For example, one particularly fascinating issue is whether sugar should be regulated. Researchers at the University of California in San Francisco argue that sugar is fueling the obesity pandemic, contributing to 35 million deaths annually worldwide from noncommunicable diseases such as diabetes, heart disease, and cancer. They argue that sugar is not just “empty calories,” but a product that causes changes in metabolism, raises blood pressure, and critically alters the signaling of hormones, causing significant damage to the liver.

Should sugar be regulated by the FDA? Seems a bit far-fetched to me, but it is just one more reason why the FDA matters. The FDA is vital to this country’s health and well-being, and while candidates in the upcoming election may ask that government be made smaller, I urge them to keep the FDA out of those conversations.

To comment on this article, contact editor@uspharmacist.com.

Popular Articles
Advertisement