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Klobuchar, Paulsen provisions work their way into FDA bills

Sen. Amy Klobuchar
Sen. Amy Klobuchar

There are two versions of the FDA bill right now (one each in the House and Senate) and both have support from the two parties and, by and large, the medical device industry. Lawmakers have also incorporated provisions introduced by Klobuchar and Paulsen into the bills, primarily those meant to speed up the way the FDA regulates and approves medical devices for use:

  • The Senate bill contains a provision meant to simplify the overly restrictive FDA conflicts-of-interest policy, legislation championed by both Klobuchar and Sen. Al Franken. The bill contains Klobuchar measures instituting an outside review of the FDA's device approval wing and instructing the FDA to take the “least burdensome” pathway to regulatory decisions (by focusing only on matters relevant to the device waiting to be approved).
  • The House bill incorporated parts of a Paulsen bill bolstering the system by which the FDA sends low-risk devices to third parties for initial approval, freeing up FDA resources to focus on riskier devices.
  • Other provisions include one offered by Franken that lifts the profit cap on so-called humanitarian devices (those that help treat rare diseases), which should allow for more production of them going forward. The Senate version of the bill also contains drug shortage provisions pushed by Klobuchar.

A March Government Accountability Office report found the FDA taking up to 61 percent longer to approve moderate-risk devices than it did in 2005. Such a slowdown has hurt both patients, who need the devices, and device companies, who industry supporters warn are moving jobs overseas where the regulatory conditions are easier.

Minnesota’s medical devices industry is some 400 companies and 35,000 employees strong, so Minnesota lawmakers, often lead by Klobuchar and Paulsen, have pushed the FDA to speed up the approval process.

Rep. Erik Paulsen
Rep. Erik Paulsen

“This really is a tax on medical innovation, nothing more,” Paulsen said.

“I think the industry would be incredibly surprised if that were to happen,” Mandle said. “There aren’t votes in the Senate for repeal today.”

Of course, if the Supreme Court scraps the entirety of the Affordable Care Act, there will be no medical device tax to do away with. And if Republicans sweep November’s elections, they could end the tax next year over any and all objections from Democrats and Obama. Mandle said the medical device industry is preparing different ways to lobby Congress depending on the scenario.

As it is, Paulsen said the progress he’s seen in the device sector has been promising, relative to the gridlock that has come to characterize Washington.

“The way that I keep my sanity is by making progress on some real issues that affect Minnesota in particular, and the med tech industry is one of the best Minnesota and American success stories,” he said. “So it would be a huge success if we could pass both of these measures and see it happen.”

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Comments (2)

"Overly restrictive" conflict of interest provision?

This piece is unabashedly biased in favor of Medtech lobbying arguments. In fact, there isn't a single critic of this legislation included, and they do exist.

That's surely the author's right, but for close observers of what is happening right now between industry and the FDA, it's not very persuasive.

1) An "overly restrictive" conflict of interest provision? I'm surprised that the reporter assumed the position of industry so casually. Some would argue there's nothing overly restrictive about the current policy. FDA research has shown it is not difficult to fill the positions with experts with no ties to industry. The fact that in the aftermath of Infuse and recalled knees and broken leads, Senator Klobuchar wants to put researchers who have been paid by industry back on the approval committees is embarrassing. She seems to have uncritically absorbed one of the primary drivers of cost creep in American medicine -- the innovation myth.

2) Where is the author's evidence for the assertion that the slowdown in device approval has hurt patients? New devices are largely retreads of previous devices, albeit marked up.

3) If industry wants to move jobs to places with lower regulatory hurdles, and the FDA wants to chase those standards, that is a losing game. There are always going to be places with lower regulatory hurdles.

4) Even the notion that a GOP sweep in November "could end the tax next year over any and all objections from Democrats and Obama" seems weird. Fillibuster? Veto?

Bad medical device

Death of a father or mother - no justice. Taxpayers pay.