Members of Minn. delegation urge FDA to speed medical device approvals

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