Write to cures@mail.house.gov by June 13, 2014. Here's why!

21st Century Cures – Patients 

“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”1 

For patients and their families, the gap between the number of diseases and the number of treatments is not a statistic; it is their daily struggle. Despite the medical breakthroughs of recent years, for many diseases, treatments or research simply do not exist. 

Through legislation such as the Food and Drug Administration Safety and Innovation Act and the PREEMIE Reauthorization Act, which included the National Pediatric Research Network Act, the Energy and Commerce Committee has sought bipartisan solutions to facilitate and accelerate patient access to innovative treatments. Although progress has been made, significant work remains. That is why we launched the 21st Century Cures initiative, and the involvement and guidance of those patients on the frontlines and their advocates is critical. Our goal of accelerating the cycle of discovery, development, and delivery of promising new treatments and cures is shared by many, but perhaps most of all by patients and their families. 

The committee appreciates that certain aspects of the discovery, development, and delivery cycle have different meanings for different patients. Depending on the condition or disease at issue, the state of biomedical research, and the translation of such research into treatments and cures, varies. We want to hear about the state of biomedical research and therapeutic innovation for specific diseases and better understand how Congress can help move the ball forward. 

To help the committee’s effort, we are seeking input from the patient community on the following questions: 

􏰀 What is the state of discovery of cures and treatments for your disease? Are there cures and treatments now or on the horizon? 

1 Statement of Margaret Anderson, Executive Director of FasterCures, at the 21st Century Cures Roundtable held on May 6, 2014, http://www.youtube.com/watch?v=Fr4Re7sfDzE&t=33m21s. 

• 􏰀  What programs or policies have you utilized to support and foster research, such as patient registries, public-private partnerships, and venture philanthropy?
  
• 􏰀  How can Congress incentivize, coordinate, and accelerate basic research for diseases we know relatively little about?
  
• 􏰀  How can we work together to better translate advances in science into safe and effective new therapies for patients?
  
• 􏰀  How do you coordinate your research and outreach with other patients?
  
• 􏰀  How do you learn about new treatments and cures? How do you communicate with other
  patients regarding treatments and cures?
  
• 􏰀  What can we learn from your experiences with clinical trials and the drug development process?
  
• 􏰀  What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
  
• 􏰀  How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit-risk? Can this process be improved?
  
• 􏰀  What is the role of public and private funding in the research and development of cures and treatments?
  
• 􏰀  Are there success stories the committee can highlight and best practices we can leverage in other areas?
  
• 􏰀  How have you worked with other patients to support one another?
  
• 􏰀  What is the financial burden of your disease? How would better treatments and cures help
  save money for your family and the federal government?
  
• 􏰀  How can Congress help?
  Public input is critical to the 21st Century Cures initiative, especially from the patient community. With the staggering gap between the number of diseases and available treatments, there are undoubtedly countless untold stories that will provide guidance and perspective in this effort. We request all submissions and suggestions be sent to cures@mail.house.gov by June 13, 2014. 

http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf

Held hostage by medical device cheerleader: Representative Erik Paulsen (R-MN)

Push to kill medical device tax isseen as way out of shutdown

Article by: KEVIN DIAZ , Star Tribune Updated: October 2, 2013 - 10:14 PM

FiDA highlight

WASHINGTON – A small group of rank-and-file House members trying to break through the impasse in the government shutdown revived talks on Wednesday aimed at repealing a health care tax that falls heavily on Minnesota’s medical device industry.

The effort is being led by Minnesota Republican Erik Paulsen, who has cast himself as the champion of an industry estimated to employ 35,000 in Minnesota. Paulsen said he discussed his proposal Wednesday with Republican House Speaker John Boehner hours before House and Senate leaders were scheduled to meet at the White House with President Obama.

“I said this can and should be part of the solution,” said Paulsen, one of about a dozen House Republicans who have signaled their willingness to drop GOP demands of defunding or delaying the Affordable Care Act, often called Obamacare, as a condition of keeping the government open.

Paulsen sponsored a measure to repeal the medical device tax as part of a GOP government funding proposal that got 17 Democratic votes over the weekend. The Democratic-led Senate stripped the language as part of a broader dispute over Republican efforts to derail the Affordable Care Act, which rolled out this week.

Minnesotans in Congress from both parties have been pressing to undo a $30 billion medical device tax levied under Obama’s health care overhaul. But the two sides have been unable to agree on a way to make up the lost revenue.

Now, with both sides looking for an end to the government shutdown, the repeal effort has been caught up squarely in the protracted politics of the standoff.

Democrats, including Minnesota Sens. Amy Klobuchar and Al Franken, have said they are unwilling to repeal the tax as part of any GOP funding measure that delays implementation of Obamacare as the price for keeping the government open.

“I continue to believe that the current continuing resolution is not the best place to work out a medical device tax repeal that the president would sign into law,” Franken said. “I think the surest way to quickly reopen the government is for the House to vote on the Senate-passed bill to fund the government at its current levels. But I will take a careful look at any proposal that emerges.”

Meanwhile, Republicans have used the issue to attack Minnesota Democrats who voted against the repeal of the medical device tax as part of a GOP funding measure that puts off the health care law.

Despite the discord, Paulsen said the repeal effort represents the best opportunity for compromise. “The number one provision in this entire debate that has brought the most bipartisan support is repealing the medical device tax,” he said. “So we’ve got an opportunity to make that the linchpin as part of a solution.”

Paulsen said he has been in talks with a group of Republican and Democratic House members, including Wisconsin Democrat Ron Kind, an opponent of the medical device tax. Kind, however, has been working on a way to offset any lost revenues that might result.

Optimism from the industry

Industry leaders expressed guarded optimism about the new push on the medical device tax, which already has collected more than $100 million.

“There is reason for optimism that there is a critical mass and bipartisan support for repealing the tax,” said J.C. Scott, chief lobbyist for the Advanced Medical Technology Association.

The House voted last year to repeal the 2.3 percent excise tax on medical device makers like Minnesota-based Medtronic, which has said the tax could cost it $175 million annually. But efforts to win passage in the Senate have been stymied by Democratic concerns about losing one of revenue streams to pay for Obama’s 2010 health care law intended to cover some 40 million uninsured Americans. The repeal measure also has faced a White House veto threat.

White House officials contend that medical device makers will benefit from the new business created by the expansion of coverage to Americans who are now uninsured.

Where state’s senators differ

While Franken and Klobuchar have vowed to get the repeal through the Senate, they differ on a key sticking point: how to make up for the revenue.

Last year’s House-passed bill would have offset the lost taxes by shrinking insurance subsidies for low- and middle-income workers under the health care law. Franken said the GOP plan would undermine the goal of affordable health care.

Klobuchar said Wednesday that she is committed to repealing the medical device tax. However, she said, “the president has made clear that he will not accept changes to the Affordable Care Act as a condition for opening the government.” That doesn’t prevent a repeal in future negotiations, she said, adding that “the best way to get there is for the House to take up the Senate bill to reopen the government so we can have those negotiations.

Paulsen said House members are working on new revenue measures. “It’s definitely something that’s being conducted by rank-and-file members looking for a way out and a solution with bipartisan support,” he said.

Even if enough Democrats come on board, Paulsen’s greatest challenge may be convincing other Republicans.

“I would call it a win,” Paulsen said. “It would be a major accomplishment that helps the economy.”

explanthis

Oct. 3, 13

1:12 PM

The medical device industry is poorly regulated. I have been a patient advocate on the federal level for nearly 5 years, testifying at FDA meetings about the high rate of failure of implanted hips, knees and surgical mesh. The industry has fought UDI (unique device identification), legal protections for harmed patients, transparency of doctor/device mfg. financial relationships and independent outcomes registries to adequately inform patients and their providers. Right now, in WV federal court there are nearly 50,000 harmed women fighting for their civil rights and compensation for 'morbid disfigurement' from multiple manufacturers of surgical mesh. The 2.3% tax is warranted and capitulation to this entitled industry by our elected representatives is undemocratic. Research on 'Failed Implanted Medical Devices'.