Senate Bill Would Streamline Medical Device Approval

When it comes to approving medical devices for patients to use, the Food and Drug Administration is handcuffed by conflict of interest rules that it says slow the process. A bipartisan trio of senators have introduced a bill that would ease the rules in favor of getting devices approved quicker, possibly at the expense of medical ethics.

Reuters reports the bill would counteract a 2007 law that stopped advisory panelists with ties to either the companies that manufacture the devices or their competitors from serving without waivers. The FDA said the law makes it difficult to find experts to fill out its panels, hurting patients by holding beneficial devices in limbo.

According to the senators, the new legislation would hold expert panelists to similar requirements in other areas of the federal government. A like-minded law is said to be in the works in the House of Representatives.

Skeptics, which include patients and consumer advocates, say the legislation is unnecessary because the FDA isn’t looking hard enough for experts and doesn’t use up its allotment of waivers.

Senators propose relaxing FDA conflict rules [Reuters]

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  1. Mighty914 says:

    Of course, once these devices are approved, no insurance company will pay for them anyway.

  2. mauispiderweb says:

    Wait, so this bill would allow people with financial ties to a company or its competitor to serve on an advisory panel without a waiver? This does not sound right.

    • Ihmhi says:

      And even better, that’s the norm for the federal government! A law finally does something right to prevent cronyism, and a bi-partisan FREEDOM SENATORIAL STRIKE TEAM OF JUSTICE gets together to fix this clearly un-American, un-Capitalistic sense of fairness!

  3. WarOtter - I went to Japan and all I got was this tumor. says:

    Finally we can make it easier on big Pharma! We’ve been so mean and unfair in not letting them approve their own devices for widespread use in a time efficient manner! This will make the process of rubber stamping so much more efficient! Maybe if we just installed a robot arm with the stamp at the end….

    • Mr. Fix-It says: "Canadian Bacon is best bacon!" says:

      Hey hey hey, back the fuck up Jack, that’s -my- patent you’re infringing on! D:

  4. SOCIALISM MARXISM WELCOME TO OBAMA'S AMERICA *fart* says:

    Star Trek is prophetic again. Americans are the Ferengi.

  5. Tim says:

    That headline is one way to phrase it. Another way: “Senate Bill Would Allow Medical Device Shills to Serve on FDA Approval Board for the Devices”

  6. E. Zachary Knight says:

    Yeah, screw medical innovation and people’s lives. Why should we let medical equipment that has been used in Europe and Asia for years make it into the US with any kind of ease? We don’t need cheaper and faster approval processes.

    Seriously. The US has the worst approval processes for medical devices in the world. We are far behind many nations when it comes to medical innovation. This law isn’t going to let companies approve their own products or let competitors block new products. There will still have to be a balance and parties will still have to disclose their relationships.

    For a nation that complains about high medical costs, we sure complain a lot when the government tries to make it cheaper and faster to get new products to the market.

    • Rachacha says:

      I would tend to agree if there is proper oversight, however budgets get cut, and if the agencies can’t attract the right people to oversee the work that is being done by the advisory committees you can lose control, just as the EPA and Department of Energy lost control of the Energy Star program http://www.gao.gov/products/GAO-10-470.

    • Temescal says:

      A decent chunk of my time at work is spent on 510(k) regulatory submissions, and I agree that the process is ridiculously tedious, especially compared to Europe. It doesn’t help that sometimes the “specialist” assigned as a reviewer to your submission seems to have no basic understanding of chemistry, biology, or even fairly simple math.

  7. TheMansfieldMauler says:

    Those greedy Republicans and their Big Pharma overseers are once again…wait, what? The Senate is controlled by who? Oh crap.

    • McRib wants to know if you've been saved by the Holy Clown says:

      My handy dandy guide to understanding politics:

      Whenever confronted with the label ‘Republican’ or ‘Democrat’ when trying to understand the intricacies of Washington, replace those labels with ‘Politician’ and stand band.

      Clarity will ensue.

      Along with horror, and a creeping understanding of the madness staring at us out of the abyss waiting to consume our world.

      :D

    • Marlin says:

      Last I checked Dems have less than 60 votes and Republicans block anything that they don’t get their way on.

      But hey why let facts get in they way, back to your faux news now.

      • TheMansfieldMauler says:

        The dems control the Senate, they could bring the bill to a vote if they wanted. Let me know when that happens.

    • Tim says:

      This is a bill. A bill that is backed by three (3) Senators. Are you familiar with what a bill is?

      Just in case you aren’t, any individual in Congress can propose a bill. The introduction of a bill does not reflect on the opinions of the chamber as a whole, any political party, Congress as a whole, etc. It only reflects the opinions of the person who introduces it and its cosponsors.

  8. FatLynn says:

    I once worked for a company that just ripped off other company’s designs and sold them for less money. Seriously, it should not take 3 years to get approval for a device because we are making it in a slightly different color.

    • StarKillerX says:

      And this is exactly one of the issues most people don’t understand, they only see the final price of a drug or device and start crying about it without considering how much time, money and effort it took to get it to that point.

  9. framitz says:

    So, in other words this change will make ripping us off through medicare fraud easier at OUR expense?

    I have no objection to helping people with real need, but I’ve seen able bodied people using medicare sponsored ‘scooters’ meant for the handicapped along with other abuses.

  10. bwcbwc says:

    So the senators are voting to allow conflicts of interest for FDA employees? Sounds like a nice gig.

  11. dush says:

    The approval panels will consist of medical device company CEOs.