Opinion: Benefit balanced against risk in the biomedical arena

By Joe Panetta

President and CEO, BIOCOM

Southern California is home to the most innovative and cutting edge biomedical research and development community in the world. Each year the region’s life science companies, along with research universities and institutes, generate thousands of ideas for potentially life-saving therapies and medical devices.

Hundreds of these potential products eventually move into clinical trials. Many potential therapies, about one in 20, never make it to market because of some type of safety or effectiveness issue. Ultimately, a few dozen will receive the approval of the U.S. Food and Drug Administration to be prescribed to patients around the country. It is a costly and time-consuming challenge, which can take up to 12 years and $1.5 billion.

In deciding what product gets to market, the FDA engages in a process that balances the risks of products versus the benefits. The FDA’s product review process has long been recognized around the world as the “gold standard” for biomedical product regulation.

It is important to understand that no product is 100 percent safe. While it may be tested in thousands of people during clinical trials, once it gets to market and is used by a wider population, new side effects may become evident. Often in those cases, the public questions how the FDA did not see the problems.

Many times reports on these side effects wind up in the media, giving biomedical companies and the FDA a black eye. The public often misses the fact that 99.99 percent of products approved by FDA have no safety issues.

Southern California’s life science community has contributed to increasing the length and quality of life of patients around the world. It is my hope that our community can appreciate all of the effort that goes into the process of developing products, and that we can better understand and accept that benefit is accompanied by risk. We must accept some level of risk if we desire life-saving innovation.



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