FDA teams up with medical device industry to write 21st Century Cures Act

iStock_000074771283_SmallShortly before Christmas Inside Health Policy, a trade pub that covers the drug industry and related topics, revealed the real power behind the rapid journey of the 21st Century Cures Act through the House of Representatives last year. It wasn’t the two dozen or so public forums held by the House Energy & Commerce Committee, the Act’s cheerleader-in-chief, or the drumbeat of messages to the media, or the shameless use of kids with rare diseases like Max and twins Brooke and Brielle to tug on Congressional heart strings. It was the medical device industry working hand-in-glove with the Food and Drug Administration, a supposedly neutral regulator looking out for the public’s health and safety.

Documents and emails obtained by Inside Health Policy through a Freedom of Information request show that “CDRH [the FDA’s Center for Devices and Radiological Health] and AdvaMed [the device industry trade group] worked together on proposed language for most of the device provisions in 21st Century Cures.” Another document reveals that in preparation for the Senate’s own version of the Cures Act, AdvaMed and the FDA collaborated “to refine their regulatory strategy in a way that is agreeable to both parties.” Still another document that was prepared for a meeting with industry on August 7 noted that the trade association “thanked” Center director Dr. Jeffrey Shuren, “for meeting with AdvaMed regularly during the legislative process for getting the 21st Century Cures Act passed” and that the regulator and the lobbyists had “jointly written legislative text.” Besides AdvaMed, attendees at that meeting included the worldwide chairman of Johnson & Johnson’s medical device group and representatives from CVRx Inc., which makes implantable devices for high blood pressure and heart failure, and St. Jude Medical, a Minneapolis-based firm that bills itself as an inventor of breakthrough medical technologies.

It’s common, of course, for the regulator and the regulated to meet and discuss rules and even proposed legislation. That back and forth is as old as the FDA itself. But the communications unearthed by Inside Health Policy and then passed on in a piece by John Tozzi of Bloomberg News ten days later add up to an uncommonly cozy relationship with much of the public being none the wiser. They should be. The Cures Act, as I’ve pointed out, has profound consequences for millions of patients and would-be patients who have stents, uterine devices, pacemakers, wire mesh, and other medical equipment planted in their bodies to cure or diagnose illness.

The Act would allow the FDA to approve such devices not based on randomized controlled trials, the gold standard for determining safety and efficacy, but on less scientific, anecdotal evidence such as case histories. Scientific studies could take place after a device goes on the market, but many researchers have found problems with that approach. The Act would require the FDA to use third parties to review the safety and efficacy of devices when manufacturers make small changes as they often do. Currently the FDA does the review. The proposed changes weaken already weak rules for device approval that have led to thousands of complaints. Prominent among them are those from women who’ve taken to Facebook to discuss their injuries with the pelvic mesh.

Where were consumer advocates in this bill drafting process? Apparently not where it counted. Susan Wood, a former FDA assistant commissioner for women’s health, told Bloomberg News, “FDA’s drafting legislation in consultation with outside entities, whoever they are, strikes me as unusual. It gives a great deal more weight to the industry representatives on very specific legislation that affects both FDA and the industry, and others were not at the table.”  That seems to be the point given the FDA’s bend-over-backward posture toward industry these days. A look at approvals of new drugs—those that are new molecular entities—illustrates the agency’s tilt. In 2015 the agency approved 45 new drugs — more than twice the number approved in 2005. A year ago a Forbes columnist proclaimed 2014 was “a good year for pharmaceutical innovation—the best, in fact, since the industry’s all time record of 1996.” The drive to get new drugs to market seems to be working, and the goal of the Cures Act is to do the same for devices.

Once again consumer advocates and others are asking, Whose interests does FDA represent anyway? I posed that question to Dr. Hooman Noorchashm, a cardiothoracic surgeon who has been waging a grassroots campaign to get a device called the Power Morcellator off the market. The FDA-approved device is thought to have spread a hidden cancer when his wife underwent a procedure for fibroid tumors. This fall Noorchashm and his wife, also a physician, met with top FDA officials, including Shuren. Noorchashm told me he left the meeting with the sense that Shuren and his colleagues believe that “getting life-saving devices into the marketplace efficiently by streamlining with industry is the goal of their agency. It is not public health and patient safety.”

If the FDA favors fox-in-the-hen house regulation and isn’t interested in policing the safety of medical devices, where does that leave the public? As the agency moves ever closer to the side of those it regulates, stories like those that Chad Tehune wrote for the Los Angeles Times in late December show how relevant that question is. The Times as well as other news outlets have investigated deaths at U.S. hospitals caused by transmission of antibiotic-resistant bacteria that remain in endoscopes even after the devices are cleaned according to manufacturers’ directions. Over a three-year period, 21 people died and more than two dozen became ill from infections related to dirty scopes in Pittsburgh, Seattle, and Los Angeles. The FDA identified 10 outbreaks; seven involved a device made by Olympus, but the paper reported: “Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections.”

Although Olympus did not tell hospitals about the dangers of their device, it did have to tell the FDA, but according to the paper those reports “suggested culprits other than its scope. The FDA issued no warnings based on those reports. Following federal regulations, it didn’t publicly identify the hospitals.” Maybe warning the public doesn’t matter much in today’s Washington.  As the Cures Act collaboration illustrates, maybe advancing the interests of industry now takes priority over ensuring patient safety at the FDA.

Trudy Lieberman is a veteran health care journalist and regular blogger for HealthNewsReview.org. She often writes about consumer cost and safety issues. She tweets as @Trudy_Lieberman.

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Comments (5)

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Gary Dulak

January 5, 2016 at 4:28 pm

Trudy, I agree there needs to be a balance between regulated industry and regulatory bodies however it is amiss to think this does not have the patients best interests at heart. This maybe in the best interest of the patients. On average, Europeans have access to new medical therapy 4-5 years ahead of Americans because of the high-bar established for efficacy. Why would it not be okay to allow Americans to have access to new technology after proven it is safe and demonstrate efficacy while being commercialized? I am not an expert in this bill but I highly doubt that FDA is going to ignore patient safety. Be careful not confuse safety with efficacy as they are two separate topics.
It is also not a bad idea to outsource independent review to a collaboration of experts for 2nd opinions and digesting the large work load that FDA has on their plates. This does not mean they give up control or oversight, it means they can contract out work when the loads are heavy. I think this makes more sense than having permanent staff to handle the heavy loads and still have to pay them when the flow is light. Don’t you?
I can tell you what we have now is inefficient, expensive and slow. We are in the 21st Century and our regulatory system needs to be as progressive as the medical device technology we are trying to introduce to patients and fellow Americans. Even today, there are a lot of unmet patient needs and we all need to work together to do better.

    Trudy Lieberman

    January 5, 2016 at 6:37 pm

    Thanks for your comment. Your point is well taken about safety and efficacy, but sometimes quick approval based on cursory data gives us neither, and that’s a problem. Having the industry do reviews presents a problem of how independent such reviews really are. The necessity for user fees and outside reviewers raise the issue of inadequate budgets to do the regulatory business of the agency. Many of our regulatory agencies are underfunded and understaffed, and they have been for a long time. If we really want good FDA oversight of new drugs,devices, and the food supply, for that matter, then we must adequately fund the agency to do the job the public has come to expect. Industry financing these activities also raises the specter of independence and objectivity. And as we know when someone pays for something there may be the expectation of something in return.


    January 6, 2016 at 2:48 am

    Gary,I do appreciate your sentiments in getting medical devices on the market for patients that really need them.Believe me when I say that they(patients)will and also do have devices inserted when the do not need them.Provisions in the 510k process already have the clause stipulating that if one medical device is similar to one which is already on the market,it gets the OK to be allowed for another similar use in another organ.Example:Biliary and pancreas stents were a copy of the heart stent.Because of the similarities in(body fluids)being blocked (arteries become blocked by cholesterol or calcium deposit), (bile duct and pancreas ducts)become blocked by congenital scarring,cancer,acquired fibrosis…)the stents then are allowed on the market.Many more side effects occur from bile duct and pancreas duct stents than that occurs from heart stenting due different functionalities of each organ.The heart pumps blood(a thin plasma)through the veins arteries.Arteries become blocked and a cannula/stent is inserted in an artery to widen the flow of once blocked chamber.It works with a very low complication rate.Contrast that with a bile duct and pancreas duct which are inserted in organs with total different properties but,have stents inserted because of similarities of functionality(fluids flowing through organ).The problem occurs when a cannula/stent is inserted.The bile duct and pancreas duct have much more different fluids (enzymes)which flow through the ducts than that of the heart which is pumped with stronger force.Heart/artery stents rarely become blocked and rarely cause pain or any other side effects. Bile duct and pancreas stents,on the other hand,become blocked with bile sludge,bacteria (which enter the blood stream).The bile duct and pancreas duct stents also migrate,dislodge and most importantly, cause HORRIBLE debilitating pain.So,even though bile duct and or pancreas stents were released on the market because of their similar property uses (moving fluids through a blocked organ),they have many more complications and cause much more pain and discomfort.
    I know first hand and live a horrible nonexistent life because of insertion of bile duct and pancreas duct stents.

Susan Molchan, MD

January 5, 2016 at 8:54 pm

Another great article by Trudy on the problematic 21st Century Cures Act. If the meetings between FDA and the industry folks to help formulate legislation were more transparent, and open to other groups, it wouldn’t look like such a cabal with patients and public health low on the priority list. And Gary, the FDA has come to approve most drugs anyway, faster than the European and Canadian agencies, and is often the first to approve (http://www.nejm.org/doi/full/10.1056/NEJMsa1200223#t=article)
Devices are another story, and the bar for their approval is much lower than that for drugs, lower still in Europe. Hence some of the disasters we’ve had, as mentioned by Trudy and others such as metal-on-metal hips. There are unmet medical needs, but as many have documented, the bottleneck is not the FDA, it’s the science, and we won’t even get into our health care delivery system.

Laura Henze Russell

January 7, 2016 at 3:22 pm

here is a petition calling for Medical and Dental Device Safety Urgent Reform (MEDDSURGE) http://www.petition2congress.com/18325/medical-dental-device-safety-urgent-reform-meddsurge/