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.
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.
“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.”
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.
Consider 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.
Rep. Marsha Blackburn calls device makers her "constituents"
Here are the meetings from July 26, 2016