• News
  • Celebrities
  • Finance
  • Crypto
  • Travel
  • Entertainment
  • Health
  • Others

Members of Congress urge FDA to speed approvals of medical devices

Members of Minnesota’s congressional delegation signed onto a letter urging the Food and Drug Administration (FDA) to speed up the approval process for medical devices.

It was signed by 41 members of Congress, including Sen. Amy Klobuchar, Rep. Betty McCollum, Sen. Al Franken, Rep. John Kline, Rep. Michele Bachmann and Rep. Erik Paulsen, who the Minnesota Independent previously reported is a major recipient of the industry’s campaign donations.

The letter notes that medical devices are appearing in Europe months or years before they’re approved in the United States.

“Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system,” the letter states.

The members of Congress offer some changes to the FDA’s approval process in the letter, including instituting a new tracking system and changing conflict of interest requirements of those serving on advisory panels.

“We recognize the need to balance risk and benefit; we all share patient safety as our primary concern, but there must be a “least burdensome approach” to achieve this without crippling an industry,” the letter states.

The medical device industry is a major backer of Paulsen, with donations from industry Political Action Committees (PACs) and executives helping to make him the lead fundraiser in Minnesota’s House delegation.

The New York Times later noted that efforts to reform the agency’s procedures are part of a push from venture capitalists investing in the industry. Congressional hearings on the subject have been overloaded with industry supporters, paying little attention to the potential dangers of medical devices.

The letter from Klobuchar and other signatories:

Dear Dr. Hamburg,

The bipartisan, bicameral Congressional Medical Technology Caucus, and other members of Congress join together to express our concerns about regulatory issues facing the medical device industry. This is an industry that has become increasingly important as dramatic improvements over the last decade have revolutionized healthcare and improved the quality of life for millions of Americans.

We share your commitment to ensuring safe and effective medical devices are available to patients. However, we are very concerned about recent declines in FDA performance. Increased review times, inconsistent expectations, and poor communication from the FDA are causing a lack of confidence and instability in the industry.

From the President’s own Jobs Council report released this month

“Today, however, our medical innovation ecosystem is in jeopardy. Investment in the life sciences area is declining at an alarming rate because of the escalating cost, time and risk of developing new drugs and devices. While many factors have contributed to this decline – including challenges around reimbursement and the general state of the economy – an important factor is the uncertain FDA regulatory environment. These concerns come at a time when Europe, China, and India continue to entice companies to take their medical research and development enterprises abroad, putting at risk our ability to keep private investment and jobs here at home.” [1]

Dissatisfaction with the approval process is no longer just anecdotal: data shows the average time to approve a 510(k) application has increased by 43% from the 2003-2007 period to 2010.[2] The average time to approve a PMA application has increased 75%.[3] The total review times for both 510(k)s and PMAs are now actually longer than they were before the user fee program was instituted.[4]

It has also become significantly more costly to get new products approved. Companies spend an additional $520,000 a month as they wait for FDA approval of a 510(k) product and $740,000 each month for a PMA product.[5] This is simply unsustainable.

Today, the United States accounts for 40 percent of the global medical technology market[6] and the industry indirectly creates two million American jobs.[7] Maintaining American leadership in this field is essential for jobs and for patients. Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system.

We recognize the need to balance risk and benefit; we all share patient safety as our primary concern, but there must be a “least burdensome approach” to achieve this without crippling an industry. We urge you to make every possible improvement to cut down device approval time by:

• Recognizing and correcting the disparity between “FDA time” versus real time when tracking device approvals

• Considering potential benefits of harmonization with international testing standards

• Addressing the unintended consequences of the conflict of interest rules for advisory panels

• Creating a transparent tracking and review system for applications and clearance decisions

These are just some of the ways the FDA can improve the process.

We appreciate the FDA’s efforts in developing an Innovation Agenda and we recognize these changes will not take place overnight. However, stakeholders from innovators and patients, to investors and physicians all note that if the FDA does not restore regulatory certainty, predictability, and transparency, investment in the industry will continue to decline and this uniquely American success story could disappear.

Sincerely,

Anna G. Eshoo Erik Paulsen

Amy Klobuchar Scott P. Brown

Richard Lugar Al Franken

Debbie Stabenow Brian Bilbray

Jay Inslee David Drier

Michael Honda Dan Burton

Betty McCollum Marlin Stutzman

Bob Filner Ken Calvert

Jason Altmire Charles Bass

Andre Carson Mary Bono Mack

Susan Davis Michael Burgess

Joe Donnelly Todd Young

Pat Tiberi Michael Rogers

Marsha Blackburn Jim Gerlach

John Kline Michael R. Turner

Charles Dent Cathy McMorris Rodgers

Michele Bachmann Brett Guthrie

Aaron Schock Glenn Thompson

Anne Marie Buerkle Chris Gibson

Bill Huizenga Patrick Meehan

Todd Rokita

cc: Kathleen Sebelius, Secretary of Health and Human Services

Discussion & Comments (0)

    Recent Articles

    • Things You Should Know about North America

      Things You Should Know about North America

      Get to know more about North America.

    • Eurovision 2010 Paula Seling Unpredictable Contest

      Eurovision 2010 Paula Seling Unpredictable Contest

      Paula Seling's experience on the Eurovision stage led her to declare that "Eurovision is an unpredictable contest". Which may explain the success of the young Lena from Germany, about whom the predictions before the event did not offer much chances for victory.

    • VIPRow.me - The Best Sports Streaming Website Today

      VIPRow.me - The Best Sports Streaming Website Today

      Have you ever contemplated creating a user-friendly site dedicated to sports-related free live streaming channels?

    • Learn How To Download, Install, And Use The Xnxubd 2022 Frame App

      Learn How To Download, Install, And Use The Xnxubd 2022 Frame App

      XNXUBD 2022 Nvidia users are able to watch thousands of videos and other contents online. XNXUBD 2022 Nvidia New is a piece of software that enables people to watch videos online without having to pay for memberships. On a graphics card, the XNXubd also provides some of the best gaming and virtual reality experiences.

    • Xvideostudio Video Editor Apk Free Download For Pc Full Version In 2022

      Xvideostudio Video Editor Apk Free Download For Pc Full Version In 2022

      A new edition of the Video Editor Apk for xVideostudio.Video Studio has all the latest features, including support for multiple video download formats in HD, FHD, and even 4K resolutions.

    • 9 Best Lotion For Masturbation - Popular Choice For 2022

      9 Best Lotion For Masturbation - Popular Choice For 2022

      Masturbation is a common activity for men and women. It's a natural and risk-free way to explore your body, experience pleasure, and release sexual tension.

    • Reasons Why You Need To Stop Watching Movies From Sflix

      Reasons Why You Need To Stop Watching Movies From Sflix

      Without having to sign up or pay anything, you can watch movies online for free with SFlix. It has more than 10,000 movies and television shows.

    • Coi Leray Mom And Dad's Family History & Wife, Explained

      Coi Leray Mom And Dad's Family History & Wife, Explained

      Coi Leray Collins (born May 11, 1997) is a rapper from the United States. Leray started publishing songs to SoundCloud in 2014, and in 2018 she released her breakthrough track "Huddy" as well as her first mixtape, Everythingcoz.

    • Listen And Download Music On MyFreeMP3 For Free

      Listen And Download Music On MyFreeMP3 For Free

      Are you in a bind and looking for a place to obtain free mp3 songs? Never again will you need to bother, since this article has everything necessary to obtain your solution. Download free music from MyfreeMP3.com, one of the world's most popular websites.