Speeding medical-device approval can save lives

Making approval process easier can be done without compromising safety

Sen. Al Franken
Guest Columnist

Bridget Cisneros’ parents thought she was a healthy baby girl when she was born in 2007. However, doctors soon discovered a hole in her tiny heart, and at a very young age Bridget faced risky and complex open-heart surgery.

Fortunately, for Bridget and her family there was another option. Skilled doctors at the University of Minnesota’s Amplatz Children’s Hospital were able to repair her problem by implanting a medical device, a much-less-invasive procedure that allowed her to avoid the traumatic surgery and lead a normal life with her family in Mendota Heights.

Her story illustrates how cutting-edge medical devices — many produced right here in Minnesota — are saving millions of lives across the country and around the world. In fact, Minnesota’s 400 medical device companies provide more than 30,000 good-paying jobs, and our state is home to more medical-device jobs per capita than any other state.

That’s why the medical device legislation that recently passed the Senate — and would unleash the innovation that drives this important industry — is critically important not only to patients like Bridget, but also to Minnesota’s economic well-being.

Central to this legislation are rules to make life-saving devices available to patients as quickly as possible while also ensuring they are safe for the people who use them.

For the companies in Minnesota and across the country that are developing new and innovative ways to treat medical problems, the current government-approval process to bring a device to market can be needlessly slow, frustrating, and costly. Minnesota device makers tell me that the long waits that accompany the current process not only deprive patients, but also stifle innovation at their companies and threaten jobs in our state.

This barrier to bringing a product to market, along with increasing cost pressures on device makers, threatens the vitality of this important industry. Today, many innovative Minnesota start-up companies are working to produce new life-saving devices, only to have federal red tape hurt their ability to thrive.

As a member of the Senate Health Committee, I’ve spent more than a year working on ways to make the approval process more responsive without compromising safety. In fact, the Senate-passed medical device legislation contains my provision to change how the federal agency that ensures devices are safe — the Food and Drug Administration (FDA) — approaches this important task.

One of my provisions allows the FDA to tap a deeper well of expertise from the medical device industry during the approval process. Many of these devices are extremely complex and require expertise that the FDA simply may not have.

By allowing the agency to more easily consult with the experts who best understand a device, we are able not only to shorten the time it takes to bring a device to market, but also to bolster support for a culture of innovation that has saved millions of lives.

A second provision I championed will require the FDA to remove guidance that could have increased overly burdensome paperwork for companies by as much as 300 percent and caused even more delays.

For Minnesota, improving the approval process has the potential to create and sustain tens of thousands of jobs, and ensure that we remain a leader in this important industry.

A third needed provision I added to the medical device bill would streamline development of devices to treat patients with rare diseases by lifting the current profit cap on what are known as “humanitarian use devices.” Eliminating this cap will make it easier for companies to develop treatments for people with rare conditions, and in turn make those treatments more accessible to patients who urgently need them.

Beyond this bill, I am also working with my colleagues to repeal the unfair excise tax on medical devices. I worked hard to successfully cut this tax in half from $40 billion to $20 billion during the health reform debate, but for an industry responsible for so much innovation — and so many life-saving devices — it remains an unfair burden.

So as Congress works to finalize medical-device policy, it’s important we encourage the culture of innovation that is thriving at hundreds of companies in Minnesota and helping create thousands of jobs.

But most importantly, we must remember what we do will determine the future health and well-being of millions of patients in this country and across the world.

U.S. Sen. Al Franken, D-Minnesota, is a member of the Senate Health, Education, Labor, and Pensions Committee, which has jurisdiction over medical device policy.

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