|00:00:00||MADAM PRESIDENT, I'D LIKE TO THANK MY FRIENDS ON BOTH SIDES OF THE AISLE FOR THEIR WORK ON THE LEGISLATION THAT WE ARE CONSIDERING TODAY, THE FOOD AND DRUG ADMINISTRATION SAFETY AND IMPROVEMENT ACT IS NOT ONLY AMONG THE MOST IMPORTANT PIECES OF LEGISLATION THAT WE WILL CONSIDER THIS YEAR, IT'S ALSO THE PRODUCT OF MORE THAN A YEAR'S HARD WORK AND NEGOTIATION.|
|00:00:23||THIS LEGISLATION WILL HELP SUPPORT A CULTURE OF INNOVATION IN THIS COUNTRY.|
|00:00:27||IT WILL HELP MILLIONS OF AMERICANS ACCESS THE LIFESAVING MEDICATIONS AND DEVICES THEY NEED WHEN THEY NEED THEM, AND AS A MEMBER OF THE HELP COMMITTEE I'M PROUD OF THE BIPARTISAN BILL BEFORE US TODAY.|
|00:00:39||I LOOK FORWARD TO PASSING IT INTO LAW.|
|00:00:44||AND LET ME TELL YOU WHY, AND OF COURSE THE PRESIDING OFFICER SPOKE SO ELOQUENTLY ABOUT THIS BILL EARLIER.|
|00:00:54||THE PRESIDING OFFICER DOESN'T REALLY HAVE TO KNOW WHY, BUT LET ME TELL YOU A STORY ABOUT A LITTLE GIRL IN MINNESOTA, OUR STATE, NAMED JOSIE.|
|00:01:03||JOSIE SEEMED PERFECTLY HEALTHY WHEN SHE WAS BORN, BUT AT NINE MONTHS OF AGE JOSIE'S PARENTS FOUND OUT SHE HAD A RARE CONGENITAL HEART DISORDER, A CONDITION WITH THE SCARY NAME OF A TREE ATRIAL SCEPTAL DEFECT, A HOLE BETWEEN THE TWO CHAMBERS IN HER HEART.|
|00:01:28||WHEN THE DOCTORS TESTED HER THEY FOUND JOSIE HAD THREE HOLES IN HER HEART AND IT BECAME CLEAR THAT WHAT WAS ORIGINALLY A FAIRLY SIMPLE SURGERY TO REPAIR THE HOLE WAS ACTUALLY A LOT MORE COMPLICATED.|
|00:01:43||BUT JOSIE IS LUCKY.|
|00:01:46||JOSIE'S PARENTS LIVE IN MINNESOTA, AND JOSIE'S DOCTOR, DR.|
|00:01:53||DANIEL GRUENSTEIN WORKS AT THE UNIVERSITY OF MINNESOTA.|
|00:01:56||HE WAS ABLE TO OPERATE ON JOSIE'S HEART BECAUSE HE HAD A BRAND-NEW DEVICE THAT THE F.|
|00:02:03||D.A. HAD APPROVED ONLY MONTHS BEFORE.|
|00:02:06||THE DEVICE, WHICH WAS ALSO DEVELOPED IN MINNESOTA, SAVED JOSIE'S LIFE.|
|00:02:12||BECAUSE OF THIS PROCEDURE, JOSIE WAS ACTING LIKE HER SAME OLD SILLY SELF THE VERY NIGHT OF HER OPERATION, AND SHE WALKED OUT OF THE HOSPITAL THE NEXT DAY.|
|00:02:24||A FEW YEARS LATER WHEN JOSIE'S LITTLE SISTER JENNA WAS BORN WITH THE SAME CONGENITAL HEART DEFECT, DR.|
|00:02:34||GRUENSTEIN REPAIRED HER HEART USING THE VERY SAME DEVICE.|
|00:02:38||BUT TOO TOO MANY CHILDREN LIKE JOSIE AND JENNA AREN'T SO LUCKY.|
|00:02:45||TOO MANY CHILDREN DON'T HAVE ACCESS TO THE MEDICAL TECHNOLOGY THEY NEEDED TO SAVE THEIR LIVES OR TO PREVENT THEIR ILLNESS OR TO HELP THEM RECOVER FROM THEIR RARE CONDITION.|
|00:02:54||THAT'S BECAUSE TOO MANY MEDICAL DEVICES GET STUCK OR DELAYED IN THE AGENCY THAT REGULATES OUR MEDICAL TECHNOLOGIES.|
|00:03:00||AND IT'S BECAUSE WE DON'T DO ENOUGH TO SUPPORT A CULTURE OF INNOVATION IN THIS COUNTRY.|
|00:03:08||LOOK, THE FOOD AND DRUG ADMINISTRATION HAS A TOUGH JOB.|
|00:03:14||THE TECHNOLOGIES THEY REGULATE ARE MOVING AT THE SPEED OF LIGHT, AND THEY DON'T HAVE THE WORKFORCE OR THE EXPERTISE TO KNOW EVERYTHING ABOUT EVERY NEW TREATMENT.|
|00:03:25||IN FACT, THE NUMBER OF ANNUAL 510-K SUBMISSIONS, THE MOST COMMON KIND OF NEW DEVICE APPLICATION THE F.|
|00:03:37||D.A. RECEIVES, HAS QUADRUPLED SINCE 1976.|
|00:03:42||THAT'S WHY WHEN THE HELP COMMITTEE SAT DOWN, WE HAD TO AGREE WE HAD TO STREAMLINE THE F.|
|00:03:47||D.A.'S PROCESSES AND MAKE THEM MORE EFFICIENT.|
|00:03:49||WE AGREE THAT WE HAD TO DO MORE TO SUPPORT A CULTURE OF INNOVATION WHICH WILL HELP MANUFACTURERS GET SAFE TECHNOLOGIES AND TREATMENTS TO PATIENTS.|
|00:04:00||AND THAT'S EXACTLY WHAT THE BILL DOES.|
|00:04:03||AND I THANK BOTH THE CHAIRMAN AND THE RANKING MEMBER.|
|00:04:09||IT REQUIRES THE F.|
|00:04:11||D.A. TO STOP USING VAGUE F.|
|00:04:13||D.A. DAYS AND START USING REGULAR CALENDAR DAYS, LIKE EVERYONE ELSE.|
|00:04:18||IT LISTS RESTRICTIVE CONSTRAINTS ON THE F.|
|00:04:23||D.A.'S CONSULTATION WITH OUTSIDE EXPERTS, SOMETHING THAT THE PRESIDING OFFICER KNOWS WELL ABOUT.|
|00:04:32||OUTSIDE EXPERTS LIKE AT THE UNIVERSITY OF MINNESOTA.|
|00:04:34||AND IT CREATES NEW INCENTIVES FOR MANUFACTURERS TO DEVELOP TREATMENTS FOR PEOPLE WITH RARE DISEASES AND CONDITIONS LIKE JOSIE AND JENNA.|
|00:04:43||THESE PROVISIONS WILL SUPPORT INNOVATION AND WILL REMOVE RED TAPE FROM THE PROCESS.|
|00:04:49||THREE PROVISIONS THAT I CHAMPIONED ARE INCLUDED IN THIS LEGISLATION IN ADDITION TO THE BASE BILL, WHICH WE NEGOTIATED AS A COMMITTEE.|
|00:04:57||THE FIRST PROVISION WILL STRENGTHEN THE FOOD AND DRUG ADMINISTRATION'S WORKFORCE BY REMOVING OVERLY RESTRICTIVE REQUIREMENTS THAT KEEP THE F.|
|00:05:06||D.A. FROM CONSULTING WITH OUTSIDE IS EXPERTS.|
|00:05:10||AGAIN, SOMETHING THAT THE PRESIDING OFFICER HAS BEEN A LEADER ON AS WELL.|
|00:05:14||THIS PROVISION WILL CHANGE THE RULES THAT KEEP THE F.|
|00:05:18||D.A. FROM TALKING WITH MANY OUTSIDE EXPERTS.|
|00:05:21||IT WILL MAKE THESE RULES CONSISTENT WITH THOSE OF ALL OTHER AGENCIES, INCLUDING THE NATIONAL INSTITUTES OF HEALTH, SO AS THE F.|
|00:05:32||D.A.'S EXPERIENCED WORKFORCE RETIRES, THE F.|
|00:05:34||D.A. WILL BE ABLE TO CONSULT WITH LEADING EXPERTS WHEN THEY ARE REVIEWING A NEW TECHNOLOGY OR A NEW TREATMENT FOR A RARE DISEASE.|
|00:05:45||THIS PROVISION WILL GIVE THE F.|
|00:05:46||D.A. THE FLEXIBILITY IT NEEDS TO CONSULT WITH EXPERTS AND KEEP PATIENTS SAFE AND AT THE END OF THE DAY THAT MEANS MORE PATIENTS WILL GET THE HEALTH CARE THAT THEY NEED.|
|00:05:57||THE SECOND PROVISION WILL REQUIRE THE F.|
|00:06:00||D.A. TO REMOVE NEW AND BURDENSOME GUIDANCE ON THE INDUSTRY THAT COULD TRIPLE THE NUMBER OF REQUIRED NEW SUBMISSIONS FOR EXISTING DEVICES.|
|00:06:11||THIS PROVISION WHICH SENATOR BURR ALSO CHAMPIONED, FROM NORTH CAROLINA, WILL PREVENT THIS GUIDANCE FROM OVERBURDENING BOTH THE INDUSTRY AND THE F.|
|00:06:22||D.A., WHICH COULD HAVE CAUSED INNOVATION TO COME TO A SCREECHING HALT.|
|00:06:26||AND MY THIRD PROVISION WILL HELP COMPANIES DEVELOP INNOVATIVE NEW PRODUCTS FOR PATIENTS ACROSS THE COUNTRY WITH RARE CONDITIONS.|
|00:06:34||ACCORDING TO THE NATIONAL INSTITUTES OF HEALTH, 25 MILLION AMERICANS STRUGGLE WITH A RARE DISEASE, AND THESE PATIENTS HAVE TO JUMP HURDLE AFTER HURDLE TO GET THE CARE THAT THEY NEED.|
|00:06:46||MANY OF THEM WILL GO FROM DOCTOR TO DOCTOR FOR YEARS BEFORE THEY FIND A SPECIALIST WHO UNDERSTANDS THEIR CONDITION.|
|00:06:52||NOW, IF YOU LIVE IN RURAL MINNESOTA, YOU MAY HAVE TO DRIVE HUNDREDS OF MILES TO FIND A DOCTOR WHO CAN HELP YOU.|
|00:07:00||EVEN FOR PATIENTS WHO FIND THE RIGHT DOCTOR, TOO OFTEN TREATMENT FOR THEIR CONDITION DOESN'T EXIST OR HASN'T BEEN APPROVED.|
|00:07:08||SO MY PROVISION WILL REWARD COMPANIES THAT CHOOSE TO DEVELOP TREATMENTS FOR PATIENTS WITH RARE DISEASES.|
|00:07:16||WE DID THIS IN 2007 TO HELP COMPANIES DEVELOP DEVICES FOR CHILDREN WITH RARE CONDITIONS, AND WE SAW THE NUMBER OF DEVICES THAT COMPANIES DEVELOP QUADRUPLE IN A FEW YEARS.|
|00:07:29||THIS PROVISION WILL HELP GET TREATMENTS TO ADULT PATIENTS WITH RARE CONDITIONS IN MINNESOTA AND AROUND THE COUNTRY, AND REALLY AROUND THE WORLD.|
|00:07:39||MINNESOTANS KNOW WHAT IT MEANS TO FOSTER A CULTURE OF INNOVATION.|
|00:07:43||OUR MANUFACTURERS HAVE DEVELOPED NEW TREATMENTS FOR EVERYTHING FROM SKIN LACERATIONS TO BRAIN ANEURYSMS.|
|00:07:49||AND THIS BILL WILL GO FURTHER TO SUPPORT THIS KIND OF INNOVATION.|
|00:07:55||BY STREAMLINING THE PROCESSES THAT ARE CURRENTLY IMPEDING INVESTMENT IN NEW TECHNOLOGIES AND MAKING THE F.|
|00:08:02||D.A. MORE EFFICIENT AND PREDICTABLE.|
|00:08:05||THIS LEGISLATION WILL HELP PATIENTS IN MINNESOTA ACCESS THE MEDICAL TECHNOLOGIES THEY NEED JUST LIKE JOSIE AND JENNA, AND IN A TIME OF ECONOMIC HARDSHIP, IT'S AN INVESTMENT IN ONE OF OUR COUNTRY'S STRONGEST INDUSTRIES, ONE OF OUR STATE'S STRONGEST INDUSTRIES.|
|00:08:27||THIS BILL IS A STEP TOWARD A HEALTHIER FUTURE FOR OUR COUNTRY, AND I LOOK FORWARD TO MAKING SURE THAT IT BECOMES PART OF OUR LAW.|
|00:08:43||I YIELD THE FLOOR AND, AGAIN, I THANK THE SENATOR FROM IOWA, THE CHAIR OF THIS COMMITTEE.|
|00:08:50||I THANK THE RANKING MEMBER FOR HIS LEADERSHIP AS WELL.|
|00:09:00||A SENATOR: MADAM PRESIDENT?|
|00:09:01||THE PRESIDING OFFICER: THE SENATOR FROM ALASKA IS RECOGNIZED.|
|00:09:05||MURKOWSKI: THANK YOU, MADAM PRESIDENT.|
|00:09:06||AT THIS TIME I WOULD ASK UNANIMOUS CONSENT TO|
Mr. FRANKEN. Thank you. I thank the Senator from Iowa for the time.
Madam President, I thank my friends on both sides of the aisle for their work on the legislation we are considering today. The Food and Drug Administration Safety and Improvement Act is not only among the most important piece of legislation we will consider this year, it is also the product of more than a year's hard work and negotiation.
This legislation will help support a culture of innovation in this country. It will help millions of Americans access the lifesaving medications and devices they need, when they need them. As a member of the HELP Committee, I am proud of the bipartisan bill before us today and look forward to passing it into law.
Let me tell you why. Of course, the Presiding Officer spoke so eloquently about this bill earlier. The Presiding Officer does not have to know why, but let me tell you a story about a little girl in Minnesota--from our State--named Josie.
Josie seemed perfectly healthy when she was born, but at 9 months of age Josie's parents found out she had a rare congenital heart disorder, a condition with the scary name of ``atrial septal defect,'' which means she had a hole in the wall between the upper two chambers of her heart.
When the doctors tested her, they found Josie had not one, not two, but three holes in her heart. It became clear that what was originally a fairly simple surgery to repair the hole was actually a lot more complicated.
But Josie was lucky. Josie's parents live in Minnesota, and Josie's doctor, Dr. Daniel Gruenstein, works at the University of Minnesota. Dr. Gruenstein was able to operate on Josie's heart because he had a brandnew device the FDA had approved only months before. The device, which was also developed in Minnesota, saved Josie's life. Because of this procedure, Josie was acting like her same old silly self the very night of her operation, and she walked out of the hospital the next day.
A few years later when Josie's little sister Jenna was born with the same congenital heart defect, Dr. Gruenstein repaired her heart using the very same device. But too many children like Josie and Jenna are not so lucky. Too many children do not have access to the medical technology they needed to save their lives or to prevent their illness or to help them recover from their rare condition. That is because too many medical devices get stuck or delayed in the agency that regulates our medical technologies. It is because we do not do enough to support a culture of innovation in this country.
The Food and Drug Administration has a tough job. The technologies they regulate are moving at the speed of light, and they do not have the workforce or the expertise to know everything about every new treatment.
In fact, the number of annual 510(k) submissions--that is the most common kind of new device application the FDA receives--has quadrupled since 1976. That is why when the HELP Committee sat down to develop this legislation, we agreed we had to streamline the FDA's processes and make them more efficient. We agreed we had to do more to support a culture of innovation which will help manufacturers get safe technologies and treatments to patients. That is exactly what the bill does. I thank both the chairman and the ranking member.
It requires the FDA to stop using ``FDA days'' and start using regular calendar days like everyone else. It lifts restrictive constraints on the FDA's consultation with outside experts, something the Presiding Officer knows well--outside experts such as are at the University of Minnesota. It creates new incentives for manufacturers that develop treatments for people with rare diseases and conditions like Josie's and Jenna's. These provisions will support innovation and will remove redtape from the process.
The three provisions I championed are included in this legislation in addition to the base bill which we negotiated as a committee. The first provision will strengthen the Food and Drug Administration's workforce by removing overly restrictive requirements that keep the FDA from consulting with outside experts, again something the Presiding Officer has been a leader [Page: S3495] on as well. This provision will change the rules that keep the FDA from talking with many outside experts. It will make these rules consistent with those of all other agencies, including the National Institutes of Health, so as the FDA's experienced workforce retires, the FDA will be able to consult with leading experts when they are reviewing a new technology or a new treatment for a rare disease.
This provision will give the FDA the flexibility it needs to consult with experts and keep patients safe, and at the end of the day that means more patients will get the health care they need.
The second provision will require the FDA to remove new and burdensome guidance on the industry that could triple the number of required new submissions for existing devices. This provision, which Senator Burr from North Carolina also championed, will prevent this guidance from overburdening both the industry and the FDA, which could have caused innovation to come to a screeching halt.
My third provision will help companies develop innovative new products for patients across the country with rare conditions. According to the National Institutes of Health, 25 million Americans struggle with a rare disease, and these patients have to jump hurdle after hurdle to get the care they need. Many of them will go from doctor to doctor for years before they find a specialist who understands their condition.
If you live in rural Minnesota, you may have to drive hundreds of miles to find a doctor who can help you. Even for patients who find the right doctor, too often the treatment for their condition does not exist, or has not been approved. So my provision will reward companies that choose to develop treatments for patients with rare diseases.
We did this in 2007 to help companies develop devices for children with rare conditions, and we saw the number of devices that companies developed quadruple in a few years. This provision will help get treatments to adult patients with rare conditions in Minnesota and around the country and around the world.
Minnesotans know what it means to foster a culture of innovation. Our manufacturers have developed new treatments for everything from skin lacerations to brain aneurysms. This bill will go farther to support this kind of innovation by streamlining the processes that are currently impeding investment in new technologies and making the FDA more efficient and predictable.
This legislation will help patients in Minnesota access the medical technologies they need, just like Josie and Jenna. And in a time of economic hardship, it is an investment in one of our country's strongest industries, one of our State's strongest industries. This bill is a step toward a healthier future for our country. I look forward to making sure it becomes part of our law.
I yield the floor.