Media Reports on Money, Muscle, and Medical Devices

NOVEMBER 14, 2011 - Former Saturday Night Live comedian turned U.S. Senator, Al Franken represents Minnesota and with Minneapolis a hub of the medical device industry, he is doing all he can for his constituents.

According to an article in the Star-Tribune Monday, November 14 (here) Franken bill to speed up medical device approval, Sen.Franken was schedule to visit Medtronic, Monday, November 14 to discuss his proposal to speed up the approval of medical devices for the market. Franken is targeting devices for rare diseases but would help all medical devices become economically viable sooner than the current Food and Drug Administration (FDA) regulatory process allows.

At least 10 bills have been introduced in the house by Republicans to urge a speedier medical device approval process.

Members of Congress urge FDA to speed approvals of medical devices

In October, 41 members of Minnesota’s congressional delegation members signed a letter to the FDA urging a speedy approval process, reports the Washington Independent (here). Sen. Amy Klobuchar, a Democrat, Rep. Betty McCollum, Sen. Al Franken, Rep. Michele Bachmann, Rep. John Kline and Rep. Erik Paulsen signed on warning “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.”

Minnesota predicts it will lose 400,000 jobs if the FDA regulates and denies medical devices and the investments that go into them.

Lawmakers suggest in the letter changes could include changing the conflict of interest rules for those who serve on advisory panels and initiating a new tracking system for medical devices.

The FDA has been the target of criticism that the approval process takes too long. Venture capitalists have complained they no longer want to fund medical device start-ups and the industry is threatening to take medical devices overseas to seek approval there.

Venture Capitalists Put Money on Easing Medical Device Rules

Venture Capitalists funded Minnesota congressman, Erik Paulsen with $74,000 in one month to sponsor a bill to make it easier to receive approval for medical devices to bring them to the market. More than $3.3 million has gone to candidates or political action committees trying to fast-track the FDA medical device approval process, according to an analysis by the New York Times (here).

Congressional hearings and private meetings have been leaning toward the medical device industry with less input from those who are warning about the dangers of untested medical devices or patients injured by those devices.

The lobbying has intensified as a medical device fee used to pay the operating costs of the FDA stands to be reauthorized by Congress. The last time the fee law was renewed was in 2007.

Here is the letter:

The letter from the 41 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