Reforming the FDA
Joe Pitts, May 11, 2012
This week, the Health Subcommittee and the full Energy and Commerce Committee approved the Food and Drug Administration Reform Act of 2012. This bipartisan legislation reauthorizes and reforms user fee programs for drugs and medical devices.
What are user fee programs? The Food and Drug Administration reviews new pharmaceuticals and medical devices to make sure that they are safe and effective. Companies canít put their product on the market until the review is complete and the product is approved.
FDA works with these industries to negotiate a fee that will help pay for government review personnel. Every five years the fees are renegotiated and the legislation authorizing these programs is renewed.
This legislation is critical to our medical innovation economy. In Pennsylvania, over 37,000 work in the pharmaceutical industry and over 22,000 work in the medical device industry. Without timely review of new products, many of these jobs would be at risk.
Over the last year and a half, the Health Subcommittee has held ten hearings to investigate aspects of the review system and prepare the FDA Reform Act. Early on, we discovered problems with the review of medical devices.
In a hearing last year, we heard from investors and venture capitalists that the review of devices had become a barrier to investment in the U.S. We also heard firsthand from companies struggling to work with the FDA.
Last fall, I became aware of the difficulties facing one small Pennsylvania company, Philadelphia-based InfraScan. The company created a non-invasive device to help detect brain injury. The companyís Infrascanner uses near-infrared light to detect bleeding in the brain.
A normal human brain will absorb light evenly. If there is bleeding, the absorption level will be different. In just a few short minutes, the device can warn medical professionals that an injury is serious and that the patient should be rushed to a hospital.
This device was developed specifically with the U.S. military in mind. In fact, they received funding from both the Marine Corps and the National Institutes of Health.
While the device was approved in Europe in 30 days, it took nearly four years for the FDA to give their assent. U.S. soldiers were actually serving next to European counterparts who had access to the device and were using it in the field.
A few weeks after I published an op-ed in the Philadelphia Inquirer highlighting InfraScanís story, they finally received approval.
Investors warned us that the difficulty of the review process is making them think twice about putting money into U.S. companies. Venture capitalists are looking to put more money into European companies. Also, some American companies are thinking about relocating facilities to countries where they could actually market their products.
The FDA Reform Act will help us turn back that tide by making the review process more transparent, more consistent, and more predictable. Helping protect American jobs isnít a partisan issue and this isnít a partisan bill.
From the beginning, I worked with my Democratic counterparts on the Energy and Commerce Committee to put together legislation we could all agree on. During the Health Subcommittee consideration of the bill, every member who spoke was grateful for the bipartisan work.
Republicans didnít get everything we wanted into the bill, and Democrats didnít fully agree with everything that did get into the bill. However, at the end of the day we compromised to move this legislation forward in a timely manner. The current law authorizing FDA user fee programs expires later this year. If we donít act in time, the FDA could be forced to lay off staff, which would delay or halt many new product reviews.
The full House of Representatives could vote on our legislation in the coming weeks. Meanwhile, the Senate is working on its own version of the bill. Work in the other chamber has also been bipartisan. Iím hopeful that we can iron out a compromise and send the bill to the President this summer.
The FDA Reform Act is critical to encouraging medical innovation. American companies are working on incredible new devices and drugs to help patients. We need to make sure these products are safe, but we donít want needless bureaucratic barriers that hurt patients and jobs.
Congressman Joe Pitts, a Republican, represents Pennsylvania's 16th Congressional District, which includes Lancaster County and parts of Chester County and Berks County.
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