Weekly Column by Lamar Alexander: “Making Medicines Safer for Our Children”

Posted on June 1, 2012

The U.S. Senate recently passed the Food and Drug Administration Safety and Innovation Act –an important piece of legislation that affects nearly every American family.

We often take our medicines for granted. But a child born in 1900 could only expect to live an average of 47 years—infectious diseases took many children before they reached their teens.

And for most of human history, diabetes meant death, but insulin was introduced in 1923 commercially, and within a few years enough was being produced to meet the needs of diabetes patients around the world.

It was not until the time of World War II that we saw the introduction of widespread and effective antimicrobial therapies with the development and mass production of penicillin.

Since then, the sky has seemed to be the limit. Half of Americans take at least one prescription drug every day. It’s a real miracle what has happened in terms of our lives with the introduction of medicines, and we rely upon the Food and Drug Administration to keep those medicines safe and effective, which is what this legislation does.

It will help safe and effective drugs and medical devices get to the market and, more importantly, get them to the market more quickly so people who need help can use these medicines and devices.

It includes the Better Pharmaceuticals for Children Act, which I cosponsored. This provides and an incentive and a requirement that pharmaceutical companies, when developing certain new drugs for adults, figure out the effect those drugs will have on children.

It takes a big step forward in making it clear what drugs will do when offered or provided to children. Currently, just under half of the drugs prescribed to children have been studied and labeled for children, but prior to the passage of these laws that we are reauthorizing, 80 percent of drugs used for children were used off-label—that is, we did not really know how they affected children.

Children are not just little adults. Children's bodies react very differently to medicines. There are examples of overdosing or previously unknown side effects. In one case in Tennessee in 1999, seven babies were prescribed an antibiotic to treat whooping cough. They became so seriously ill, they needed stomach surgery. The Centers for Disease Control later linked their illness to the antibiotic, which had never been tested in young children.

According to the Institute of Medicine, as of October 2010, the FDA has approved 425 labeling changes as a result of studies or analyses done under these laws.

Children also differ widely in sizes and growth rates, so for medical devices doctors often must either jerry-rig devices or be forced to use a more invasive treatment. This bill encourages manufacturers to bring more pediatric devices to the market and strengthens FDA post-market surveillance of devices used in children.

Additionally, the bill will help address problems with the medical device approval process by improving the regulatory process. In Tennessee we have many medical device makers, especially in Memphis. Many believe the FDA is over-regulating medical devices, which negatively affects the industry's ability to raise capital and create jobs, without making those devices any safer.

It also addresses the growing problem with antibiotic resistance by providing incentives and reducing regulatory burden to help drug development keep up with the pace of resistance.

It will give the FDA additional tools to help prevent drug shortages and require FDA to look internally at regulations to see if the FDA is making the problem worse. I worked on a review of federal initiatives to combat prescription drug abuse and to issue a report on those. Tennessee ranks second in the nation for prescription drug use. Gov. Haslam and our legislature took action this year to deal with abuse of these drugs. We intend to help them.

The legislation takes one more step in our dramatic journey from a country with almost no medicines to a country in which almost everyone takes some medicine—where the lifetime of the average American has increased from 47 years in 1900 to 78 years today.


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