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Morcellation Media Monitoring 7/9/15
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House Passes Bill to Improve Safety Monitoring of Medical Devices
Jul 12, 2015 | The Wall Street Journal
By Jennifer Levitz
A sweeping medical research bill that passed the House on Friday included a provision aimed at improving safety monitoring of medical devices—an amendment inspired by a controversial gynecological device. -
H.R. 6 blows through House vote, but White House says 'sequester'
Jul 10, 2015 | Pharmacy Choice
By Federal Information & News Dispatch
Congressman Mike Fitzpatrick (PA-8) successfully added an amendment to the 21st Century Cures Act [H.R. 6] Friday which begins the process of reviewing medical device safety and raising awareness about power morcellators. -
Fitzpatrick Amendment Addresses Shortcoming in Medical Device Safety
Jul 13, 2015 | Medical Device Daily
By Mark McCarty
Legislation for the 21st Century Cures program produced an avalanche of support from patients and the life science industries, and the House of Representatives responded with a 344-77 vote in favor of H.R. 6, which now moves to the Senate with a $9 billion price tag. One question is how the Senate will handle its end of the task, but the White House threw a damper on the celebration via a July 9 press release stating that President Obama "has concerns about providing additional funding" to the National Institutes of Health "without addressing sequestration more broadly."
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House Passes Bill to Improve Safety Monitoring of Medical Devices
Jul 12, 2015 | The Wall Street Journal
By Jennifer Levitz
A sweeping medical research bill that passed the House on Friday included a provision aimed at improving safety monitoring of medical devices—an amendment inspired by a controversial gynecological device.
With the amendment from Rep. Mike Fitzpatrick, (R., Pa.), lawmakers would express “a sense of Congress” that “unique device identifiers” should be included in electronic health records.
Supporters say information such as the make or model number of devices used in treatment should be included in medical records so patient harm can be closely tracked. Currently, the identifiers “are not incorporated into all electronic health records, which makes it difficult to fully achieve the benefits to patient safety,” Mr. Fitzpatrick’s office said in a statement.
The amendment is part of the so-called 21st Century Cures bill, which would boost federal funding for medical research and changes drug approvals.
There is no parallel bill in the Senate, but Sen. Lamar Alexander (R., Tenn.), chairman of the Senate health and education committee, has said he hopes to get a measure through his panel by year-end and bring it to the Senate floor next year. It is uncertain whether it would contain similar language.
The Food and Drug Administration issued a rule in 2013 requiring labels of medical devices to include unique device identifiers and said it would phase in the system over several years, focusing first on high-risk devices. Mr. Fitzpatrick’s office said his action “adds pressure.” The FDA declined to comment on the amendment.
It is unclear what practical impact the amendment will have, but Mr. Fitzpatrick used it as an opportunity to open a larger debate about how devices are regulated and tracked. He said he had been moved to action by devices called laparoscopic power morcellators.
The tools were previously used in tens of thousands of minimally invasive procedures a year, mostly in hysterectomies, to cut up benign uterine growths known as fibroids so the bulky tissue could be removed through tiny incisions. Last year, however, the FDA warned that women undergoing the procedure have an estimated 1 in 350 chance of harboring a dangerous hidden cancer that power morcellators can spread and worsen.
The agency called for a black-box warning—its strongest caution—on the tool. Johnson & Johnson, which was the largest manufacturer of the device, pulled its version off the market last July, while many hospitals have halted or limited use of morcellators. Morcellators made by other companies remain on the market.
The FDA has cleared at least 10 power morcellators for sale since the first one hit the market 24 years ago. Though records from device applications and reviews show the FDA knew in the early days that morcellators could spread dangerous cells, the agency said the magnitude of the risk wasn’t realized until the issue gained prominence in late 2013.
The system under which morcellators and nearly all other devices were authorized has long drawn criticism for being too lax. The FDA has defended it as a good way to balance innovation and safety.
“What happened with the power morcellator should never be allowed to happen again,” Mr. Fitzpatrick, who is a cancer survivor, said at a hearing of the House Rules Committee last week before the Friday vote on the bill.
Several other amendments, offered by Mr. Fitzpatrick and prompted by the morcellator issue, didn’t make it through the Rules Committee. One amendment would have directed the Government Accountability Office to investigate FDA medical-device safety reporting regulations, “focusing on reporting problems involving power morcellators.”
Speaking in opposition was Rules Committee member Rep. Michael Burgess, a Texas Republican and a doctor who formerly practiced obstetrics and gynecology. Mr. Burgess, who said he left active practice more than 10 years ago and didn’t use power morcellators, argued that doctors, rather than regulations were to blame for problems resulting from the device. “In this instance, I think that it was clinical judgment that was at fault, not the FDA approval process,” he said.
Mr. Fitzpatrick’s constituents include Amy Reed, a Philadelphia-area anesthesiologist whose cancer was worsened by a morcellation procedure in 2013.
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H.R. 6 blows through House vote, but White House says 'sequester'
Jul 10, 2015 | Pharmacy Choice
By Federal Information & News Dispatch
WASHINGTON, D.C. - Congressman Mike Fitzpatrick (PA-8) successfully added an amendment to the 21st Century Cures Act [H.R. 6] Friday which begins the process of reviewing medical device safety and raising awareness about power morcellators.
The amendment, which was passed unanimously, "[e]xpresses a sense of Congress that recording Unique Device Identifiers (UDIs) at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for post-market surveillance purposes."
The FDA established the UDI system to adequately identify medical devices through their distribution and use and can significantly improve safety and help track down dangerous recalled products. But currently UDIs are not incorporated into all electronic health records, which makes it difficult to fully achieve the benefits to patient safety. For example, a claim form might list a procedure to remove uterine fibroids, but not note the make or model of the device used - such as the laparoscopic power morcellator: a device with an FDA black box warning and has been recalled by some manufacturers as a result on its devastatingly adverse effects on women's' health. Fitzpatrick's amendment adds pressure to increasing use of UDIs in digital medical records.
Fitzpatrick's floor remarks are below (full video at: https://www.youtube.com/watch'v=4iceQwypIHc&feature=youtu.be):
"Before I talk about this amendment, I want to express my deep appreciation for the work of Chairman Upton and Ranking Member Degette on this bill. The funding and these innovative reforms will save lives and that's something everyone in this chamber should be proud of.
I'm a member of the Rare Disease Caucus. And like most of us here, I've met constituents with incredible stories of courage; stories of their battle with diseases without treatments. It would be easy to fall victim to despair. But they don't. They remain beacons of hope. Hope for a treatment. Hope for a world where no one else has to go through what they did. And they look to us to support them. To fight along side them for these treatments and lifesaving research. And I'm proud to stand and fight with them.
But there is a part of this bill I believe will do more harm than good. And that's the part that eases medical device safety regulations. While we bring our research and treatments into the 21st century, I think it is equally important we bring our medical device safety regulations into the 21st century.
As part of a 21st Century approach to medical devices, the FDA has established a unique device identification (UDI) system to adequately identify medical devices through their distribution and use. These codes can significantly improve safety and help track down dangerous recalled products.
But currently these UDIs are not incorporated into all electronic health records, which make it difficult to fully achieve the benefits to patient safety. For example, a claim form might list the procedure, like routine surgery to remove uterine fibroids, but not note the make or model of the device used, such as the laparoscopic power morcellatora device that the FDA placed a black box warning on, some manufactures have recalled, and some insurances companies have stopped covering as a result of its devastatingly adverse effects on women's health.
it's this tragedy surrounding the power morcellator that has driven me to action. It's why I offered 8 amendments to the rules committee that would strengthen our safety laws.
This week I've heard from dozens of these individuals affected by the complications from power morcellation:
* One doctor from California sent me a note about how her sister died 9 months after a routine surgery with a power morcellator.
* A woman from Massachusetts described her battle with the cancer that was spread by a morcellator.
* Another in New York, lost her sister to cancer spread by the morcellator and described her sister's tragedy as "a routine surgery ending with a death sentence."
* And a constituent of mine, a doctor and mother of 6 children, who is courageously fighting an aggressive cancer that was spread by the blades of this device.
What happened with the power morcellator should never happen again. And I think we missed an opportunity with this bill to tackle this problem head on.
In 2011, the Institute of Medicine found the current, four decade old medical device safety process known as 510(k) inadequate - noting "510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices" I wish this bill addressed this gap that allowed the power morcellator to slip through and cause unnecessary harm to too many families.
It's time we take our medical device safety regulations into the 21st Century. I ask my colleagues to join me in this effort and to support my amendment which is a small, but important step. I'm proud to stand for patient safety, and I urge my colleagues to stand with me and the thousands of others who have been injured or killed by unsafe medical devices."
Fitzpatrick gave the following statement regarding his vote against the underlying legislation:
"As a cancer survivor, I know firsthand how important medical research is to American families and the hope that this research can provide. As a member of the Rare Disease Caucus and Deadliest Cancer Caucus, I have made the fight against cancer and rare diseases a top priority during my time in Congress. Medical research saves lives and saves our economy billions of dollars annually in prevented illness and costly treatments.
Simply put, funding innovative therapies, treatments and medications and streamlining our government's rule is a worthwhile cause. However, an equally important objective is protecting the health and safety of patients - especially when it comes to the approval and use of medical devices.
Unfortunately, I felt the 21st Century Cures Act fell short of this important goal.
I offered 8 amendments regarding medical devices safety looking to strengthen the process by which devices are evaluated and monitored before and after they reach market. And, while one of my amendments was approved by the House and passed as part of the underlying bill, I still had concerns about shortcomings in Congress' response to the dangers of unsafe devices like the power morcellator.
This legislation now goes to the Senate and I look forward to continuing to work with my colleagues in both chambers to strengthen this bill with modern medical device safety regulations."
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Fitzpatrick Amendment Addresses Shortcoming in Medical Device Safety
Jul 13, 2015 | Medical Device Daily
By Mark McCarty
Legislation for the 21st Century Cures program produced an avalanche of support from patients and the life science industries, and the House of Representatives responded with a 344-77 vote in favor of H.R. 6, which now moves to the Senate with a $9 billion price tag. One question is how the Senate will handle its end of the task, but the White House threw a damper on the celebration via a July 9 press release stating that President Obama "has concerns about providing additional funding" to the National Institutes of Health "without addressing sequestration more broadly."
The White House statement includes references to patient input into regulatory decision making at FDA, and says that the administration "in particular . . . appreciates the legislation's support for the President's Precision Medicine initiative." The statement claims that a failure to tackle the sequester threatens "not only NIH research, but also other investments in innovation." The letter register's the President's objections to the use of inventory in the Strategic Petroleum Reserve as part of the pay-for in H.R. 6 as well.
The administration also pointed out that the measure underfunds the tasks FDA would be charged with, and the President added that H.R. 6 "could undermine regulatory standards by allowing unproven uses of therapies to be marketed to health care payors as though such uses had been proven safe and effective."
The first failed amendment to H.R. 6 came from Rep. David Brat (R-Va.), who voiced opposition to "the creation of a new mandatory program." Brat, whose amendment has widely been described as a poison pill, said his offering introduces "a bit of reason to the budget process of the United States," adding that by 2027, "all federal revenues will be spent only on mandatory programs," leaving "zero dollars for running the government."
House Energy and Commerce Committee chairman Fred Upton (R-Mich.) said he "strongly oppose[s] this amendment because making this funding discretionary" would delete potential savings to entitlement spending. Upton said CBO has projected "this bill would reduce the deficit by some $500 million-plus" in the first few years, and then save the taxpayer another $7 billion in the second decade. The legislation, however, offers only five years of financing for NIH and other agencies. Brat's amendment went down with more than 140 aye votes, only half the 281 votes registered against the measure.
Former Energy and Commerce chairman Rep. Joe Barton (R-Texas) decried the calls for offsets and other measures that might thwart the bill, stating that Medicare Part D had no offsets. He said the underlying legislation for Part D had support from nearly all Republicans and almost none from Democrats. Barton added, "I wish the entire federal government were discretionary except for Social Security, but it's not. Let's come together" and "vote for something we can all be proud of," Barton urged the House.
Rep. Michael Fitzpatrick (R-Pa.) offered an amendment to address what he described as "the tragedy surrounding power morcellators." Fitzpatrick's amendment essentially lent support to the use of unique device identifiers at the point of care in electronic health record systems, which "could significantly enhance the availability of medical device data" for post-market surveillance, according to the legislative record.
"What happened with the power morcellator should never be allowed to happen again," Fitzpatrick said, citing the 2011 IOM study of the 510(k) process as corroboration of a purportedly broken review mechanism. "It's time we take our medical device safety regulations into the 21st Century," Fitzpatrick urged. This amendment passed on a voice vote.
Rep. Jared Polis (D-Colo.) came up with a medical device-related amendment that ran in a somewhat different direction, an interesting development given that Polis' home state is not known for being a particularly device-intensive locale. He said Congress "should start thinking about what the next step is" in clearing out regulatory impediments, suggesting a two-tiered approval process for devices, which in this framework would be approved based on safety, then monitored for efficacy, essentially replicating the system used in the European Union.
Polis said a device maker might need $30-$100 million to get a device to market in the U.S., adding, "in the European market, [the device] reaches market in seven to 11 months," but the same device might need up to four years in the U.S. "simply because our own government is keeping that product off the market even though that product is safe."
This amendment would create a two-tiered process for review of device applications, and mandate that FDA turn out a report on the potential impact of such an approach. Polis said, "provisional marking of the product in American can and will save lives," but the proposal drew only modest support. Upton said "the issue has merit, but we have to make sure it's designed the right way." Upton indicated that the amendment was late to the process, but said he would work with Polis on the concept. Rep. Frank Pallone (D-N.J.) seconded Upton's comments, stating, "we do understand the purpose of the Polis amendment," vowing that he would support "follow-up, and have perhaps a meeting with FDA as well."
Steve Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said in a July 10 statement that H.R. 6 "represents an important and significant first step toward strengthening the American innovation ecosystem." He cited the expedited path for devices designated by FDA as breakthrough technologies, but added that the legislation "also provides resources to FDA to implement these important reforms" along with insulation of user fees from the sequester. However, Ubl said the association opposes provisions that would apply Medicare payment rates to durable medical equipment in the Medicaid program.
Jim Greenwood, president/CEO of the Biotechnology Industry Organization (BIO; Washington), said in a July 10 statement that H.R. 6 "prioritizes placing patients at the center of the drug development process, which we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs." Greenwood also supported the legislation's insulation of user fees from the sequester.
Mark Leahey, president/CEO of the Medical Device Manufacturers Association (MDMA; Washington), said in a July 10 statement that the association "thanks Chairman Upton and Congresswoman (Diana) DeGette (D-Colo.) for their bipartisan leadership on the '21st Century Cures Act' to speed up the discovery of and access to medical technologies for patients and providers." Leahey said MDMA "will continue to work with members of Congress to improve" the bill as the Senate works on its own version, "and to help ensure that the final legislation spurs innovation and patient care."
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