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FDA Funding: Medical Device Makers and Lap Dog Watchdogs

Consumers Union Safe Patient Project

Consumers Union Safe Patient Project

Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates.

The Medical Device User Fee Agreement IV (MDUFA IV) will be delivered to Congress in January.

It represents the work of more than a year of negotiations between FDA regulators, industry and patient and consumer groups, all known as “stakeholders” according to FDA jargon.

The agreement promises the FDA will collect close to $1 billion in fees (plus inflation) to improve the industry including hiring more reviewers and enhance their training. The CDRH is known to have tremendous turnover which in turn, slows the medical device approval process.

The fees come from industry whether a premarket application to have their medical device approved (PMA) or a 510(k) clearance. The fee for a 510(k) application on average was just under $3,000.

However, for the 68 % increase in the current device user fees, there is a catch.FDA logo 2 200

 

Faster Review Times

Chief among what industry wants is more “timely” access to the marketplace with with less red tape. “Least burdensome” is how the FDA refers to the ideal arrangement.

Most medical devices make it to market after a 290 day 510(k) clearance process.  Medical device makers want that fast-tracked to 108 days by 2022.  For a De Novo submission (or a novel or new medical device), that time would be extended to 150 days.

MDUFA IV also requires the the FDA to provide feedback to industry at least five days before they meet over the pre-submission and to document in detail the reasons for a deficiency letter.

So far this year the FDA has had 11 meetings with industry including representatives from AdvaMed, a Washington DC lobbying group, Medical Device Manufacturers Association, Johnson & Johnson, Cook, Boston Scientific, Laboratory Corporation of America, as well as some consumer group representatives.  Industry groups were reported to be optimistic over the reauthorized MDUFA.

ASR Hip 2000 the daily mail uk

ASR Hip

“This tentative agreement is good news for FDA and industry, and most importantly for patients worldwide,” said Scott Whitaker, AdvaMed president and CEO. “This agreement will allow for continued progress in improving the efficiency and predictability of the agency’s review process, and that means doctors and patients will have more timely access to the innovative tests, treatments and cures they are depending on.”

 

Consumers Stakeholders

The FDA has been regulating medical devices since 1976 but with very little oversight. Often a high-risk device can make it to market with just one clinical trial.  Some with none.

The 510(K) clearance process requires a paper submission and naming a “substantial equivalent” and a “predicate” medical device already being sold.  The 510(K) clearance process does not require clinical trials but in some cases, such as pelvic mesh for pelvic organ prolapse (POP), post-approval monitoring may be required.  This allows the manufacturers to monitor their devices after they are already permanently implanted in patients, as is the case with POP mesh.

The 510(k) clearance process is the FDA process that has allowed polypropylene transvaginal surgical mesh onto the market as well as metal-on-metal hip prosthesis, defective defibrillators and stents, leading consumers to ask “least burdensome to whom?”

An Institute of Medicine report in 2011 (here) called the 510(k) approval process “fatally flawed” and suggested it be abolished.

Consumers Union’s Safe Patient Project argued that in years past the politically powerful medical device industry successfully blocked much needed patient protections from the House and Senate versions of MDUFA, despite that most Americans polled believe the safety of patients should be the FDA’s most important mission. See a MND background story here.  See the Safe Patient Project. 

The consumer group reminds the public that the FDA currently does not have the power to require a medical device maker to fix a defective design flaw that can injure consumers.  A flawed medical device can still serve as a “predicate” devices upon which others name to seek approval of subsequent devices.

bs logoConsider ProteGen by Boston Scientific. Approved through the FDA’s fast-track 510(k) clearance process in 1997, two years later it was recalled by Boston Scientific after hundreds of complications were reported including chronic pain and life-threatening infections.  There is no mechanism within the FDA to stop using ProteGen as a “predicate” and today it is the device that serves as the predicate for a generation of pelvic meshes to follow.

Consumers Unions wants lawmakers to give the FDA the authority to require that industry fix a defective medical device. Background story on MND here.

“Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed? The answer is obvious. But for months, their lobbyists have been working to block Congress from giving the FDA the power to require this proof. Meanwhile, thousands of women have suffered devastating injuries from vaginal mesh products based on an older, recalled model. And device makers are also free to market hip implants and defibrillators based on recalled versions. Consumers Union is calling on Congress to close this dangerous loophole in the law and give the FDA the power it needs to protect patients. Because sometimes a loophole is more than an error – it’s a disaster.”

By 2012, Public Citizen found Congress had introduced 14 bills to accelerate medical devices’ path to the market with one goal in mind – a more permissive process to gain market access.  MDUFA in 2002 and 2007 did not substantially change the regulatory framework but in 2007 MDUFA gave stakeholders and Congress the opportunity seek changes in the approval process unrelated to user fees.  Public Citizen reports at least 36 device makers hosted campaign fundraisers for members of Congress in 2011.

Read the history of MDUFA in this 2012 Public Citizen report, Substantially Unsafe.

The Sound Devices Act, introduced by Rep. Edward Markey in 2012 would have given the FDA the authority not to approve a medical device where the “substantial equivalent” was found to be defective or recalled.  The House voted 46-0 to defeat the legislation.  See MND story here.

 

LEARN MORE:

Rep. Marsha Blackburn calls device makers her “constituents”
http://www.meshmedicaldevicenewsdesk.com/jim-shull-observations-on-how-lawmakers-view-medical-device-regulation/

Here are the meetings from July 26, 2016
http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM518202.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

15 Comments

  1. J Maxwell says:

    Ok! So do I understand this correctly…the FDA is getting 1 Billion $$$ to do something when it’s already too late for us who have ongoing complications because lobbyist in the industry pushed this ‘stuff’ through to make $$$ and we will be deceased before our loss of work and out of pocket medical complications are compensated for. Glad the FDA made money off us!

    • Jane Akre says:

      I believe it to be their operating budget,, in other words money they will spend, not pocket. It represents one half to one-third of expenditures of the agency.

    • Kitty says:

      The FDA…no doubt staffed with young men and women who consider themselves so clever and creative..the darlings that were brought up on bedtime stories. STICK IT TO GRANDMA AND GRAMPA NOW!! ..the ugly big bad wolves spreading Whooping cough to their grand children. F— THE FDA!

      • Bejah Blue says:

        I agree with Kitty, This is obscene and deeply troubling. As far as I am concerned it is more of thir tactic of buying everyone off. I am so sick of it. Shame on the FDA. I have lost all respect and trust for this agency.

        Bejah

  2. Barbara Melling says:

    This is insane!
    Get the fox out of the hen house it’s
    Curupt.

  3. Barbara M says:

    Insane we need to see congress

  4. Sea says:

    Too many politicians getting too much pocket money from the companies in charge of lobbyists ….Corrupt …..need to get the politicians out of Washington get rid of lobbyists ….and get the judges to follow the law of justice not their own agenda ….Sick sad news about us who suffer …..

    • Bejah Blue says:

      It is just the same thing that has always gone on. I see no change, no cleaning up the corruption, nor do these individuals and organizations understand that the day will come when they have destroyed this nation with their greed and violations of the rule of law. Bejah

  5. Janis Urban says:

    The World is Watching! They want Patient Advocacy to Shut Up & to Shut it Down. But hold on! We have the Numbers now. Most of us Mesh Injured know we are not alone in this battle for Medical Device Safety etc. There are several ways even with our disabilities that we can make life a living hell, for all A-Z! For those Gagged in Silence in this Travesty of so-called Justice System. It can’t affect your day in court. We are a lot smarter. It just needs a little more organization. One Hand Washes the Other? Unity for All!

  6. Thanks Jane for putting these issues on the radar. For those of you who want to act, watch for this Congressional debate as it unfolds early in 2017. And then call your Congressional members about your concerns. In 2012, Congress told us that they were not hearing from patients who were concerned about safety of devices (we later made sure they did). They were mostly hearing from device companies that have now perfected the act of getting desperate patients to advocate for more devices, quicker. So, make your voices heard in early 2017.

    • Jane Akre says:

      Lisa thank you. Consumers Union does an amazing job. Check out their proposal to warranty medical devices… Kind of like your washer and dryer… Safe Patient Project.

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