Rep. Fred Upton in the Holland Sentinel: FDA Reforms Benefit Michigan Patients, Jobs

May 30, 2012

Today, the House will consider the Food and Drug Administration Reform Act, H.R. 5651. This legislation, which works to strengthen the United States' leadership position in an industry that supports millions of American jobs, will reauthorize FDA user fees to ensure continuation of various FDA programs and the creation of new ones to facilitate the review and approval of life-saving, life-improving drugs and medical devices. The FDA Reform Act includes performance goals and reforms that ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation. The following op-ed from Energy and Commerce Committee Chairman Fred Upton (R-MI), published shortly after the bill was unanimously approved by the committee, spells out the benefits of the FDA Reform Act: "Our bipartisan reform package is the culmination of more than a year of work and negotiations between House Democrats and Republicans, all of whom recognize the importance of a more efficient, transparent, and consistent FDA for our nation’s patients, healthcare providers, and job creators."

 
FDA Reforms Benefit Michigan Patients, Jobs
Holland Sentinel
By Rep. Fred Upton
Published on May 16, 2012

This past week, the House Energy and Commerce Committee took a major step by passing bipartisan legislation that will make important reforms in the Food and Drug Administration’s (FDA) evaluation and approval process for new medical products.  From the latest medical devices to tomorrow’s drug treatments, these reforms will enable U.S. manufacturers to get their breakthrough products to market faster while maintaining the highest levels of patient safety. 

That is good news for the life sciences industry and the thousands of jobs that depend upon it here in Michigan, and certainly it is wonderful news for countless patients from across the country who await the delivery of these life-saving innovations.

Earlier this month, I met with the employees of local medical industry innovators Pfizer and Stryker, two of Southwest Michigan’s largest employers.  The medical device and drug industries employ thousands here in Michigan - jobs that are now being threatened by the lack of predictability in the FDA approval process.  A slow and uncertain approval process is detrimental to American jobs and competitiveness, putting U.S. companies at a severe disadvantage with foreign competitors.  The United States has long been the global leader in medical innovation - thanks in large part to the work being done right here in Michigan - but that position could soon be jeopardized if reforms are not enacted.  What’s more, ongoing delays at the FDA have come at a serious cost to American patients whose lives depend upon the availability of these new drugs and medical technologies. 

While Michigan medical product manufacturers have had to hack their way through a jungle of bureaucratic red tape, companies in Europe have flourished, commanding a larger share of the global market including here in the United States.  That is simply unacceptable.

Our bipartisan reform package is the culmination of more than a year of work and negotiations between House Democrats and Republicans, all of whom recognize the importance of a more efficient, transparent, and consistent FDA for our nation’s patients, healthcare providers, and job creators.

These reforms are part of broader legislation that will extend the FDA’s current user-fee programs - which are now set to expire in September - for an additional five years.  The expiring programs - the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) - both play an essential role in ensuring that groundbreaking medicines and technologies reach the patients who need them.  Our bipartisan reform bill also supports new user-fee programs for generic drugs and biosimilars, helping both reach the market faster to provide a greater range of affordable healthcare options to patients.

As we extend these programs, we have a must-act opportunity to improve the review and approval process, maintaining important safeguards for patients while encouraging the development of cutting-edge products. 

I applaud the work of our entire Energy and Commerce team - Democrats and Republicans - to move this process forward and hope to see this legislation reach the President’s desk before the end of summer.  As an issue of importance to jobs, patient care, economic growth, and medical innovation in Michigan, completing reauthorization of these programs and enacting commonsense reforms at the FDA must be a top priority and is an issue upon which we can all agree.

Congressman Fred Upton (R-St. Joseph) represents Michigan’s Sixth Congressional District and serves as Chairman of the House Committee on Energy and Commerce

http://www.hollandsentinel.com/opinions/x1035953558/MY-TAKE-FDA-reforms-benefit-Michigan-patients-jobs

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