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Statements on Introduced Bills and Joint Resolutions S650

Location: Washington, DC


By Mr. DeWINE (for himself, Mrs. CLINTON, Mr. GREGG, Mr. DODD, and Mr. KENNEDY):

S. 650. A bill to amend the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain research into drugs used in pediatric patients; to the Committee on Health, Education, Labor, and Pensions.

Mr. DeWINE. Mr. President, I rise today to talk about a very important subject—one that affects parents, doctors, hospitals, nurses and our children each and every day. The subject that I am talking about is the safety and efficacy of the medicines that doctors give our children when they are sick.

Nearly six years ago, I was astonished to learn that close to 80 percent of drugs on the market were not tested for use in children—yet, doctors were prescribing these drugs to our children. Doctors had no choice but to prescribe these drugs for children if they thought the medicines would be helpful. And, sometimes the medicines did help—sometimes a child's pain was relieved, or a child would be able to breathe easier or digest food better because of the medicines the doctors prescribed them. But, even when the drugs do work, an anxious feeling remains among doctors and parents about whether these medicines are safe for children. How are doctors and parents to know for certain which medicines will work if they haven't been tested for safety and efficacy in children?

There are many examples, of situations where drugs have been mispre scribed for children because doctors simply weren't aware of the effects these drugs would have on kids. For example, the drug, Neurontin, which is used to treat chronic pain, was given to children without being properly tested, and doctors eventually learned they were under-dosing children by 50 percent. That means children were suffering from pain because they were being under-dosed. They weren't being given the proper dose of medication to relieve their pain.

Another drug, Lithium, which has been prescribed to treat bipolar disorder since 1940 was never tested for long-term use in children until just a few months ago. This is an example of a drug that doctors have been prescribing "off-label" for years, and only now we are finally getting some evidence of its effect in children. According to doctors, the testing of Lithium revealed important information because children who suffer from bipolar disorder cycle between mania and depression quicker than adults, and they can even have signs of both at the same time. Unlike adults, they don't have periods of normalcy. Doctors now know that Lithium can be used to treat bipolar disorder in children.

Doctors have taken a chance in prescribing medicines for children. Doctors tell parents to cut a pill in half or in quarters so it can be given to a child. Doctors use the best information they have to determine how much or what kind of medicines to give a child. That is all they can do when the medicines children need have not been tested for their use.

Doctors and pediatricians should not be left to guess how much medicine our children should receive. And, parents shouldn't have to feel anxious or question whether the half a pill that's been ground up and put in applesauce will still be effective in treating their child—or whether it's even safe for their child to take.

It's been over a year now since the Senate passed and the President signed into law the Best Pharmaceuticals for Children's Act. As many of my colleagues know, that law has been part of a solution—but just a part of a solution—to address the problem I just mentioned. The law provides a six-month patent extension to pharmaceutical companies in exchange for the testing of medicines in children. And, for as long as the bill has been law, the Food and Drug Administration is reporting its success in ensuring that more medicines are tested for use in children. With the incentive provided by Best Pharmaceuticals, companies are seeing the value of studying their drugs in children and are applying for the patent extension.

But, the Best Pharmaceuticals incentive cannot work alone to ensure that medicines in children do not go untested. The incentive in the Best Act was never intended to work alone. When the Best Act became law, there was already a rule on the books that helped ensure that no medicine used to treat children, including vaccines or other biologics, would go untested. Back in 1997, the Food and Drug Administration proposed what is known today as the Pediatric Rule. The Pediatric Rule allowed FDA to require that the drugs the agency felt are important for children are safe, effective, and properly labeled for children.

Unfortunately, the Pediatric Rule has come under legal challenge, with a District Court ruling just a few months ago stating that FDA lacked the statutory authority to require pediatric studies. This was a troubling step backward for children's health—a troubling step at a time when 75 percent of the medicines on the market still aren't tested and labeled for pediatric use. We've made some improvements from the 80 percent of medicines on the market, but 75 percent is still too much. Without the Pediatric Rule, new medicines and biologics coming onto the market are not required to be tested for use in children. Congress needs to make sure that the FDA continues to have every tool—that includes the market incentives and the pediatric rule—available to them to ensure that drugs for children are tested for safety and efficacy and that they are labeled properly.

Everyday that a drug manufacturer chooses not to participate in the incentive program, the number of medicines that go untested for use in children increases. Everyday that we don't have the Pediatric Rule, we sacrifice our children's safety. Medicines that are used by children should be tested for safety and efficacy. That is why Senators CLINTON, GREGG, DODD, and KENNEDY and I are introducing a bill today—the Pediatric Research Equity Act—that would ensure that the Pediatric Rule continues to work alongside the Best Act, so that children will remain on safe footing when it comes to the testing of the medications they use.

Congress needs to make sure the Pediatric Rule stays in place, because right now, the Pediatric Rule and the Best Act incentive work together to ensure that drugs are tested for use in children. As I said already, the Best Act was never intended to substitute the rule, but rather to reinforce and work with the rule. For example, the Pediatric Rule may be invoked in instances where pediatric information is essential, but the patent exclusivity is no longer available.

The Pediatric Rule also applies to biologics, whereas the Best Pharmaceuticals does not. A significant portion of therapeutics used in children, including many cancer treatments, are biological products (products that include a live agent). Because Best Pharmaceuticals does not apply to biologics, the Pediatric Rule is the only way to ensure pediatric labeling.
Finally, the Best Pharmaceuticals is voluntary. For any number of reasons, including insufficient sales, a manufacturer may choose not to conduct the testing necessary to receive additional exclusivity under the Best Act. But, just because a drug manufacturer chooses not to study the drug in children does not mean that drug is not critical to the proper treatment of our children. Without the Pediatric Rule, there is no way to guarantee that a drug that is used in the pediatric population is tested for children's use.

With the establishment of the Pediatric Rule and the financial incentives of the Best Pharmaceuticals law, there has been a dramatic increase in the number of studies that have been undertaken. Let me quote from the Government's Response to Plaintiff's Notice of Reauthorization of FDA Modernization Act. This is the document that the government filed to defend the lawsuit against the Rule: "These two options [the Best Pharmaceuticals for Children Act and the Pediatric Rule] have resulted in a number of drugs being labeled for use in pediatric populations. As of March 31, 2002, 94 applications containing complete or partial pediatric use information had been submitted to the agency. Of these 94 applications, 45 are attributable to the statutory exclusivity provisions. FDA attributes 48 of the 94 applications to the authority of the pediatric rule alone."

The bill that my colleagues and I are introducing today would help maintain that progress—not erode it. Our bill would provide the FDA with the authority it needs to ensure that the medicines children take are studied for safety and efficacy. And, our bill would give FDA this authority in a way so that it does not conflict with the incentives provided in the Best Pharmaceuticals Act.

Our bill would preserve the waiver and deferral process, so that drug companies can get waivers or deferrals for a range of legitimate reasons. Drug companies could get a waiver or deferral of studies for safety or ethical concerns. A drug company could get a waiver or deferral if the pediatric testing would interfere with the drug's availability for adults.

Ultimately, though, our bill would help make certain that children are no longer a therapeutic afterthought by ensuring that all new drugs are studied for pediatric use at the time a drug comes to market. This would put children on a level playing field with adults for the first time. Our children deserve no less, and I encourage my colleagues to join in support of this legislation.

I ask unanimous consent that the text of the bill be printed in the RECORD.

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