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

Indeed, as The Washington Post reported over the weekend, that failure to lend a financial hand for the sake of fixing the broken health care system has made the industry few friends on the Senate Finance Committee, which has proposed $40 billion in fees on medical device makers over the next decade, when those companies are estimated to pull in $2 trillion.

Yet, this being Washington, even that proposal is getting pushback from lawmakers representing states where medical device makers are most concentrated. From the Post:

Democrats and Republicans from Minnesota, Indiana, New Jersey and other states with prominent medical device operations are rallying to oppose the proposed fee, which would collect $4 billion annually from the $130-billion-a-year industry. Fourteen Democratic senators sent a letter to Senate Majority Leader Harry M. Reid (Nev.) and other top Democrats last week, urging them to “moderate” the levy, which they said will “threaten the existence of some manufacturers” and cause “significant job reductions” for those that remain. Five GOP governors also have weighed in with objections.

“The issue here is that these are very good jobs in our state and in our country,” [Sen. Amy] Klobuchar [D-Minn.] said in an interview, acknowledging that she is among a group of “strange bedfellows” rallying around the industry. “You want to be very careful when you start assessing taxes on an industry like this.”

And herein lies what’s perhaps the most significant hurdle facing the Obama administration as it attempts to fix health care this year. The medical-industrial complex is a $2.3-trillion-a-year behemoth. And even the most wasteful of that spending creates jobs somewhere, thereby producing a perverse incentive for congressional lawmakers to protect regional interests at the expense of national ones. The device makers are only one tiny sliver of that much larger trend. But they should be careful. Regional protectionism has its perils.

California Democratic Sens. Dianne Feinstein and Barbara Boxer last Friday sent a letter to Democratic leaders claiming the fees would kill jobs in their state.

California is home to more medical device workers and companies than any other state. Our state is home to 1,300 medical technology firms, which create more than 112,000 related jobs. These California firms represent about 20 percent of total United States medical device sales and approximately one-third of the industry’s jobs.

The showdown highlights the primary struggle facing Democratic leaders trying to rein in medical spending to keep care affordable and federal programs sustainable. That is, the medical industrial complex has evolved into a $2.3 trillion-per-year colossus, and any proposed cuts are sure to get blasted by lawmakers trying to protect regional interests — even when those regional interests run counter to national interests.

Last week, the Finance Committee defeated Kyl’s amendment to eliminate the medical device fees altogether. But the saga is far from over. Indeed, Dow Jones is reporting today that the Advanced Medical Technology Association, the nation’s leading device lobbyist group, is in discussions with Baucus’s office about reducing the fees from $40 billion to $15 billion over 10 years.

“A deal might come within days,” Dow Jones says, citing unnamed industry sources.

The central problem in health-care reform is that good policy and good politics point in opposite directions. Good policy proceeds from the understanding that our health-care system is a fractured, pricey, inefficient mess. Good politics, however, proceeds from the insight that a lot of people rely on this fractured, pricey, inefficient mess and don’t trust Washington to change it. Good politics means, as Barack Obama frequently says, that if you like what you have, you get to keep it. But put those imperatives together and you have a strange problem indeed: How do you reform a system that you’re not allowed to change?

It’s an argument that’s perfectly applicable to almost every reform effort lawmakers tackle. That is, even if some industry, or project, or siphon of federal spending is utterly frivolous — even if it’s utterly pernicious — it’s still likely that livelihoods depend on it, and therefore someone in Congress is going to defend it. (For recent examples, look no further than the F-22 fighter jet, or the presidential helicopter, or the push to force the automakers to keep dealerships around even if they’re not selling cars).

Still, the medical industry presents a special case, if only because it’s so enormous (projected to hit $2.6 trillion this year) and because it’s had so many decades to become entrenched. Indeed, any reform efforts will have to receive at least the partial blessing of the nation’s doctors, nurses, hospitals, drug makers, insurers, medical device makers, clinical labs, nursing homes, pharmacists and home-care specialists — not to mention the patient advocates and state governors.

And while the effects of canceling the presidential helicopter are limited largely to one district in New York, every lawmaker in the country has the pressure to keep doctors, hospitals and patients happy. In light of all of this, the wonder is not that the Democrats have been forced to delay their health reform votes, it’s that they’ve been able to get as far as they have.

As the Project on Government Oversight reveals in a special report today based on internal FDA document obtained by POGO,  senior officials within the FDA made this decision without public notice.  Manufacturers have been trusted to monitor themselves ever since.

The problem is particularly alarming because last year the U.S. Supreme Court ruled that patients harmed by these devices have no right to sue the manufacturers, if the device was approved by the FDA.

So now, the FDA is letting the manufacturers set their own safety standards, and the Supreme Court is shielding those manufacturers from lawsuits.

So who’s watching out for the hapless heart patient?

Update: Congress could step in to do that.  First, it could boost funding for the FDA and require it to enforce those laboratory safety standards the agency effectively discarded.  Second, it could pass the Medical Device Safety Act of 2008, which would nullify the Supreme Court’s decision in Riegel v. Medtronic last year and restore the rights of patients injured by medical devices to sue the companies that made them — restoring a critical incentive for manufacturers to ensure the safey of their own products.