Food and Drug Administration Reform Act

Floor Speech

By:  Ed Markey
Date: May 31, 2012
Location: Washington, DC

Mr. MARKEY. Mr. Speaker, I want to thank Chairmen UPTOn and PITTS and Ranking Members WAXMAN and PALLONE for their work in bringing to the floor a bipartisan bill that provides FDA additional resources to bring new drugs and medical devices to market. These new resources will enable FDA to improve review times for new product applications and provide companies greater clarity about compliance requirements and their responsibilities.

There are many important policy improvements in this bill. They include:
A reauthorization of the user fee programs for prescription drugs and medical devices, as well as the creation of a new generic user fee program that will help slash current review times for these products.

A reauthorization of two programs that foster the development and safe use of prescription drugs for children.

New incentives for the development of antibiotics, which are needed to increase the number of products in the development pipeline.

Today's bill also includes the reauthorization of legislation I authored in 2007 that has helped spur the development of medical devices for children. The Pediatric Medical Device Safety and Improvement Act, PMDSIA, creates grants that bridge the gap between the people who understand the medical need--doctors and innovators--with the people who can help turn their ideas into devices on the shelves, like manufacturers and federal regulators. Since the grant program's inception, the five Pediatric Device Consortia established as a result of this language have assisted in advancing the development of 135 pediatric medical devices. Currently the consortia are managing 80 active pediatric medical device products.

The FDA Reform Act also extends a provision of PMDSIA that provided profit incentives for companies to develop devices for rare pediatric diseases. The original incentive passed in 2007 solely for pediatric diseases proved immensely successful. Today's bill strikes a compromise to extend this incentive for devices used to treat rare diseases in adults as well, while still retaining the incentive for pediatric devices. I urge Congress does not negatively impact the development of devices for children.

In addition, we will need to ensure that companies using this incentive and making a profit on their device because they got pediatric labeling actually continue to sell their device for use in children and not only for adults. The Pediatric Advisory Committee at the FDA will need to play a vital role in this oversight and in monitoring the number of devices sold for adult use as opposed to the number sold for pediatric use.

PMDSIA also included a requirement that device companies provide FDA with information on the pediatric populations that could benefit from a new device they are looking to sell. This was supposed to help FDA track what devices are available for children and where gaps remain. FDA put out a proposed rule and a direct to final rule simultaneously to implement the provision, but it withdrew the direct to final rule after industry voiced opposition. The regulation has languished ever since.

The failure to implement this provision of the law has made it difficult for FDA to provide Congress information about the availability of pediatric medical devices and to identify unmet medical device needs, according to a GAO report. I am disappointed that this important tracking provision has gone unimplemented for nearly five years, and I hope that FDA will comply with the timeframe included in the legislation to issue a final rule implementing the law no later than December 31, 2013.

Despite these advances, today's bill is a missed opportunity because it fails to address a glaring patient safety issue that affects patients around the country.
Many Americans would be surprised to learn that ninety percent of medical devices are not required to undergo clinical testing in humans prior to being sold. Instead, most devices, including brain stents and hip implants, need only to show similarity to an earlier product to make their way to market.
Under current law, the FDA is required to clear certain medical devices as long as they demonstrate their similarity to an earlier product. This is true even if the new device is modeled after a defective device that caused serious injury or even death.

If the device is indeed similar to the earlier model, flaw and all, FDA's hands are tied. The agency does not have the legal authority to deny approval.
This makes no sense.

We wouldn't fast-track approval of a new drug that was based on one that had been recalled.

We shouldn't do it here, either, with medical devices.
This legislation was an important opportunity to address this medical device safety loophole, but it doesn't. The loophole remains in place and patients are still at grave risk.

Thousands of patients have already been seriously harmed by this loophole. Four years ago, Jaye Nevarez, a 50 year-old mother of three, was a healthy truck driver who earned a decent living, played in a band, and paid her bills on time. Then her doctor implanted bladder mesh, a device that traces its origins back to an older product that had to be recalled for causing serious injury and even death.

Jaye now lives in constant pain. She was forced to quit her job. She can't walk without a cane. She lost her insurance and faces a growing mountain of medical debt. The bank recently began foreclosure proceedings on her home where she lives with her 79 year-old mother.

Jaye isn't the first to be harmed by this loophole. If we fail to fix it, she won't be the last.
As documented in the accompanying report prepared by my staff--``Defective Devices, Destroyed Lives'', several medical devices that have been recalled because they severely injured patients continue to be used as models for new devices--many of these are on the market and being implanted in patients today.

I introduced the Sound Devices Act, providing FDA the ability to protect the public from these unsafe devices, but this was not included in the bill.
The definition of insanity is doing the same thing over and over again and expecting a different result. When it comes to medical devices we have an insane policy that makes no sense.
Despite repeated testimony from the FDA that the current law restricts their ability to assure the safety of medical devices, Republicans have refused to acknowledge and address this very dangerous loophole.
This bill must not be the last word on medical device safety. I hope my colleagues will join me to close this medical device loophole so that we can keep the American public safe from harm.

Lastly, I remained concerned about the mandatory clinical trials database that was created in the 2007 FDA Amendments. This registry and results database was meant to directly address issues stemming from a lack of transparency of clinical trials. Several high profile examples, including the drugs Paxil and Vioxx, gained national attention when their manufacturers were found to have suppressed clinical trial data that demonstrated safety and efficacy concerns.
Today, the website requires information about certain clinical trials to be publically posted on the database, but loopholes in the underlying law still allow researchers and companies to avoid publishing unfavorable data, putting human subjects of clinical trials at grave risk. To protect the public from potentially dangerous drugs and medical devices these loopholes must be closed to provide equivalent transparency of all clinical trials. I hope I can work with my colleagues to address this serious issue in the very near future.