Observations

July 1, 2002 marks the 100th anniversary of the passage of the 1902 Biologics Control Act, which gave the federal government authority to regulate biological products and ensure their safety for the American public.

The act not only serves as the underpinning for the FDA's regulation of biological products today, but also marked a historic turning point in the way America protects the health of its citizens.

The FDA's Center for Biologics Evaluation and Research is responsible for the regulation of "biologics," medical products such as vaccines, blood and blood derivatives, allergenic patch tests, HIV and hepatitis tests, gene therapy products, cells and tissues for transplantation, and some treatments for cancers. For more on the FDA's oversight of biologics and its role in the development and review of the first vaccines against infectious diseases such as polio, see our story titled "100 Years of Biologics Regulation."

Antibiotic resistance has been called one of the world's most pressing public health problems. Today, virtually all important bacterial infections in the United States and throughout the world are becoming resistant to antibiotics, also called antimicrobial drugs. Antibiotic resistance can occur when bacteria change in a way that reduces or eliminates the effectiveness of drugs designed to cure or prevent infections. The bacteria that survive continue to multiply, causing more harm. Our cover story titled "Battle of the Bugs: Fighting Antibiotic Resistance," will help you learn how to use antibiotics wisely.

Botox Cosmetic injections are all the rage among aging baby boomers and others eager to erase the wrinkles of their furrowed brows. You've probably seen or read news stories touting the popular, paralyzing alternative to some plastic surgeries. Find out the latest in our article titled "Botox Cosmetic: A Look at Looking Good."

We also unravel the twists and turns of the FDA's thorough drug review process, complete with a two-page centerfold that illustrates the main steps involved with developing a new drug. See "The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective."

And are you wearing the right shades this summer? We tell you what you need to know about protecting your eyes from the sun's rays.

Raymond Formanek Jr.
Editor