Mr. President, all of us here in the Senate share the same goal of making sure the Food and Drug Administration remains the gold standard for drug safety and effectiveness, and this legislation moves us closer to that goal.
Throughout our country, researchers, scientists and doctors are making 21st century medical advances, and this legislation will ensure that we have a 21st century FDA. It will provide the resources, authority and oversight to ensure safe drugs move from the lab to the medicine cabinet without delay.
Like other members of the Senate, I worked on the FDA reforms in the 1990s. Those reforms responded to the challenges we faced then, and this bill responds to the challenges we face today.
In recent years, we’ve seen problems at the FDA with drug approval and post-market surveillance. This bill addresses those challenges and ensures the FDA has the resources and tools to promptly and thoroughly review new drugs and medical devices.
This bill:
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Reauthorizes and improves two pieces of legislation that will be critical in providing a timely review process, -
Creates a new system to actively monitor drugs after they’ve been approved by the FDA, -
Strengthens science at the FDA and improves transparency, -
Improves oversight and information about clinical trials, -
And, works to prevent potential conflicts of interest among advisory committee members.
Drug Safety
Mr. President, like many Americans, I was shocked at the recent revelations concerning drugs that posed risks to public safety but remained on the market for far too long. This legislation moves to address those concerns by instituting strong new protections including post market studies that will be publicly available. I believe that this new transparency and vigorous oversight is the right path toward restoring public confidence in the FDA.
Medical Care for Children
This bill also takes critical steps to improve medical care for children.
The Best Pharmaceuticals for Children Act included in this bill uses incentives and regulations to put America’s children first. It builds upon legislation first enacted in 1997 that ensures pediatric medicine is a priority and that information on pediatric drugs in readily available. It extends and improves a program that has undertaken nearly 800 studies and has helped to provide pediatric labeling information for 119 drugs.
The Pediatric Research Improvement Act included in this bill is another critical component of improving pediatric care. It provides needed safety measures through mandatory clinical trials. It will help continue pediatric oversight programs that have required trials for more than 1,000 pediatric drugs since 1998. All too often, doctors are not given guidance on the proper doses of prescription drugs for children. This bill will help eliminate the guesswork so children get the right doses for safer, more effective treatment.
This bill also provides help to our nation’s children through the Pediatric Medical Devices Safety and Improvement Act. Every year, we see wondrous technological improvements in medical devices. However, sometimes those improvements do not account for the needs of children and the pediatricians who treat them. This means that essential, often life saving devices don’t meet the size, scope, and needs of sick children. This bill will push manufacturers to develop and produce devices that are safe and effective for children and infants. Through incentives and investor outreach this bill will ensure that exciting advances in life saving devices are not limited to adults.
Mr. President, this legislation delivers greater safety while also providing better access. I believe that it will improve the way we deliver safe, innovative healthcare in America, and it’s my hope that it will also begin to restore confidence in the institutions that safeguard the public’s health.
The American public deserves nothing less than the gold standard of care from the FDA.
When a nervous parent or a weary senior visits their corner pharmacy they deserve to know that the products on those shelves have been approved by a thorough and complete process.
When a patient begins to take a new drug they deserve a system that is actively tracking that drug and providing the patient with information on potential risks.
And everyone – drug companies, researchers, patients, and doctors alike deserve a system that supports an efficient and timely FDA approval process.
I’m eager to vote in favor of this legislation so that it can begin to deliver what the American people deserve.
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