A trip to the local pharmacy to get a prescription filled is a routine errand for many people. Having a well-stocked medicine cabinet has become part of the American way of life.
That’s because pharmaceuticals have become an integral regimen of modern medicine that helps manage pain, curb life-threatening illnesses, treat diseases and heal what ails us in mind and body.
As a federal lawmaker, I take seriously the oversight responsibilities prescribed by the Constitution. During my years of public service in Washington, D.C., I have made it my business to meddle pointedly within the muddle of the federal bureaucracy. Iowans have entrusted me to hold the federal government accountable.
From the Pentagon to the Federal Bureau of Investigation (FBI), the Internal Revenue Service (IRS) and the U.S. Department of Agriculture (USDA), I monitor events very closely to make sure the federal government is doing its job. That includes balancing national security interests with individual civil liberties. It means working to balance taxpayer rights with tax fairness. As one of 535 lawmakers who hold the purse strings to Uncle Sam’s spending sprees, I have earned considerable seniority in the U.S. Senate. This allows me to practice principles of fiscal conservatism. I work to rein in federal spending and stretch hard-earned tax dollars to do the most public good with less sacrifice by working families.
When it comes to the Food and Drug Administration (FDA), I want to see the federal agency fulfill its mission to protect and promote the health of the public. This year the FDA celebrates a century of service since President Teddy Roosevelt signed a law in 1906 that created the federal government’s oldest consumer protection office.
Consumer protection. That’s been the basis for my sharp-nosed oversight of the FDA. Holding regulatory responsibilities for consumer products that bear significant impact on the health and survival of Americans, the FDA’s umbrella covers products that represent nearly one-quarter of consumer spending. That includes 80 percent of the nation’s food supply, pharmaceuticals, vaccines, medical devices, cosmetics and animal drugs and food.
The FDA is pressured by patient advocates and pharmaceutical companies to get life-saving drugs expeditiously to market. It is by no means my intention to stand in the way. I’m working to make sure the FDA also sticks to its mission to protect public health.
Parents, especially, rely on the integrity of government scientists at the FDA to ensure the safety of prescription drugs available on the market. Last year I investigated allegations the FDA may have held back information about possible dangers with antidepressant drugs used to treat youth.
This year I wrote a letter to the FDA to express my concerns that it might be dropping the regulatory ball on a class of drugs prescribed to treat attention deficit disorders and hyperactivity.
Specifically, I’m concerned FDA’s regulatory responsibilities haven’t kept pace with the explosion of prescriptions written to treat 2.5 million children with these drugs. Many people are concerned ADHD drugs are over-prescribed. Despite psychiatric and cardiovascular risk signals associated with this class of drugs, it appears the FDA has failed to promptly respond to the possible adverse side effects related to these drugs. Such events may include sudden unexplained deaths, strokes, cardiovascular irregularities or aggression, anxiety and depression.
Sales of drugs prescribed to treat Attention Deficit Hyperactivity Disorder (ADHD) have zoomed to the moon, jumping from $759 million to $3.1 billion between 2000 and 2004. And yet, the FDA seems to have adopted a wait-and-see approach before charting a course of action to study these risks.
A federal drug advisory panel, in an unexpected action in early February, recommended that the FDA include its strongest “black box” warning to alert adults and pediatric patients using ADHD medications of possible cardiovascular side effects.
The recommendation brings even more urgency to the controversy surrounding the explosion of prescriptions being filled with these medicines. As the debate unfolds, I will continue to closely track the FDA and urge its timely, thorough review of these drugs. With millions of Americans, mostly children, regularly taking these medications, it is essential the FDA leaves no stone unturned to investigate and review this class of drugs.
The parents administering ADHA medicine every day to their children, or those struggling with the decision whether or not their child ought to use the drug, deserve to know all the facts in a timely manner.
I understand the FDA is challenged every day to balance drug safety with consumer demand for blockbuster, miracle drugs and medical devices. From cosmetic Botox injections to inhaled insulin treatments and life-saving heart stents, the FDA certainly has its work cut out for it in its second century of service. But it must first and foremost maintain its mission to protect the public health.