ICYMI: FDA reform a triumph for patients and jobs in Michigan

July 11, 2012

 

FDA reform a triumph for patients and jobs in Michigan

The Detroit News

By Rep. Fred Upton

There aren't a lot of success stories coming out of Washington these days, but here's one you should know about.

Congress recently passed the Food and Drug Administration (FDA) Safety and Innovation Act, a measure I authored as the chairman of the House Energy and Commerce Committee.

Despite the conventional wisdom that rancor, partisanship and gridlock are permeating our nation's capital, this legislation defied the odds and made it across the finish line. It was signed into law this week.

The FDA reform measure offers new hope for patients with a wide range of illnesses, ranging from rare, life-threatening cancers to more chronic conditions.

It assists those on the front line fighting to cure diseases and help people live healthier, more productive lives.

And it will promote jobs, innovation, and investments right here in the United States. That is especially good news for Michigan, with our burgeoning life sciences sector that already employs tens of thousands and is a national leader in developing the latest lifesaving drugs and medical devices.

The legislation garnered strong and vocal support from more than 40 groups and organizations with an active presence in the 6th Congressional District, including the Juvenile Diabetes Foundation, the University of Michigan Hospitals and Health Centers, the Alzheimer's Association, the Association of Community Cancer Centers, the Michigan Biosciences Industry Organization, and more. Large employers in my district like Stryker, Pfizer and Perrigo also weighed in with enthusiastic endorsements.

This broad group of supporters came together because Congress listened and chose answers over acrimony.

Here are some of the ways the FDA Safety and Innovation Act accomplishes these goals:

It provides the government with fresh performance metrics to speed the approval process for pharmaceuticals and medical devices. The new law improves accountability, consistency, transparency and efficiency at the FDA, imposing critical benchmarks to ensure the U.S. remains the world leader in medical innovations. And by doing so, keeps jobs in the life sciences industry in this country. I've heard from many Michigan companies who want to expand their operations to meet the growing demand in this sector. This legislation will give them the certainty to make these future investments right here at home.

Many of these reforms were based on suggestions from patients and innovators who shared first-hand experiences of how the current system hinders patients' access to American innovation. The law will ensure the FDA no longer wastes taxpayer and innovators' resources because of bureaucratic red tape.

Those most involved in this field warned us repeatedly that costly and slow approvals of drugs and devices threatened the core of the life science industry in the U.S. Other countries — in Europe or Asia — were developing faster and safer protocols. As a result, we were losing our competitive edge, and this has hurt all Americans, including American patients. One of these patients, Marti Conger, had to travel to England to get access to a device originally developed and manufactured by an American company 40 miles from her home in California. The company was forced to move its manufacturing facilities, and the related jobs, overseas due to the FDA's inability to give timely approval to its devices. The FDA Safety and Innovation Act addresses these problems, which will keep jobs, investments and cutting-edge therapies here at home.

The new law takes important additional steps to aid those with rare illnesses, especially kids. It provides new and creative incentives for the development and accelerated review of drugs for rare pediatric diseases, including cancer.

We also included provisions to allow the FDA to engage with patients in new ways during the drug and device review process, adding new opportunities to improve the safety, speed and quality of how the overall system works.

The FDA Safety and Innovation Act also helps patients, doctors, nurses, pharmacists and hospitals grappling with our nation's drug shortage crisis by mandating that manufacturers report problems with their supply and expediting the FDA's review of drug applications related to shortages. It also authorizes a "root cause" analysis of drug shortages to prevent supply scarcity in the future.

It is well-known that citizens are disappointed with the performance of Congress and the federal government. Yet with this legislation, we proved that hope triumphs when policymakers put solutions above stalemate. The FDA Safety and Innovation Act is a victory for common-sense progress toward curing disease and improving lives. It should serve as a small antidote to the symptoms of disillusion so many feel about the way Washington works.

Congressman Fred Upton, R-St. Joseph, represents Michigan’s 6th Congressional District in Washington and is Chairman of the House Energy and Commerce Committee.

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