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Posted by
Whitney Thompson
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February 21, 2012
Burgess Presses FDA on Drug Shortages, FDA Responds By Allowing Importation of Replacement Drug
“This action is a step in the right direction, but it is only temporary and the FDA will need to continue to work on a long-term solution for this and other drug shortages.” Washington, D.C. – Last week, Congressman Michael C. Burgess, M.D. (TX-26), Vice Chair of the House Energy and Commerce Committee’s Subcommittee on Health and Chairman of the Congressional Health Care Caucus, pressed the Food and Drug Administration (FDA) about drug shortages, specifically Doxil a chemotherapy drug, during the Energy and Commerce Subcommittee on Health hearing, “Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages.” Today the FDA announced that they will allow a temporary importation of Lipodox, a replacement for Doxil. Upon the announcement, Dr. Burgess issued the following statement: “This action is a step in the right direction, but it is only temporary and the FDA will need to continue to work on a long-term solution for this and other drug shortages. Simply importing drugs from other countries is not a solution, but was unfortunately a necessary step in a drastic situation. Importing drugs should not become the norm, and it could be avoided by improving communication on the front end to avoid shortages. “Drug shortages happen for many reasons, and there is no silver bullet. However, when they occur, each case must be approached, dissected, and dealt with. Chemotherapy drugs are different than other drugs and you can’t just switch a patient from one chemotherapy drug to another. “I have raised this issue many times during Energy and Commerce Committee hearings. As I said in the hearing last week, when doctors don’t have essential tools they may be restricted in what they can do for patients, and that can result in a life being saved or lost. A physician never wants to tell a patient they can’t receive the care they need simply because a product is not available.” ###
Posted by
Whitney Thompson
on
February 17, 2012
Burgess Votes Against More Delays and Deeper Deficit
“Today’s congressional vote buys just a few months, at a terrible cost – with another temporary and uncertain non-solution.” Washington, D.C. – Today, Congressman Michael C. Burgess, M.D. (TX-26), Vice Chair of the House Energy and Commerce Committee’s Subcommittee on Health and Chairman of the Congressional Health Care Caucus, stood with Medicare patients and their doctors in rejecting another effort by Congress to merely delay the financial decision that must be resolved for a long term solution to the Sustainable Growth Rate formula used to reimburse Medicare treatment. Dr. Burgess opposed combining three big policy pieces that each deserve individual consideration and separate votes. This legislation obscured the tough decisions about financial priorities by mixing together the physician payment, a payroll tax holiday, and extension of unemployment benefits. “My record and my reasoning consistently support government’s commitment to ensuring patients have access to their physicians within Medicare, but not to treat this arrangement with another round of uncertainty and just another delay to the solution,” said Dr. Burgess. “I will continue to work for a positive and reliable result for Medicare patients and their physicians. Today’s congressional vote buys just a few months, at a terrible cost – with another temporary and uncertain non-solution. I am not supporting this repeated delay to a solution, but I will support the certainty that Congress knows must be in place so that doctors will have their doors open to receive Medicare patients.” Dr. Burgess cited the need for lengthening the Sustainable Growth Rate for 2 years, not the half-measure of 10 months that also lacks a needed update for the rate. He also noted the missed opportunity for Congress to correct the continued lack of support for standardizing Medicare coverage for DXA bone density scans for early identification of osteoporosis. Additionally, inserting the extensions of unemployment rates and the payroll tax holiday, said the congressman, come at the price of adding $100 billion to the deficit this year. “There are those in Congress who fail to think of the cost of the government’s borrowing authority that with this legislation’s spending speeds government along even faster than the current spending limit of $10,000 a second,” said Dr. Burgess. “The non-solution to the payroll tax for workers continues to be an unacceptable diversion of the FICA payments from going into the Social Security Trust Fund.” “Kicking the decision once again down the road and right to the edge of the calendar in the final days of the year is even more dangerous when I look at the problems that collide at one time at year’s end – expiration of the current middle income tax cuts, this Medicare physicians reimbursement, and the payroll tax cut – all with no plan to pay for it, but to spend deeper into deficit.” The conference report passed the House by 293 to 132 followed by Senate approval of 60 to 36. ###
Posted by
Whitney Thompson
on
February 14, 2012
Dr. Burgess spoke on the House Floor in recognition of the 39th anniversary of the homecoming of Congressman Sam Johnson. You can watch the video below.
Posted by
Whitney Thompson
on
February 13, 2012
Dr. Burgess appeared on Fox Business' Power and Money with David Asman to discuss President Obama's energy budget. You can watch the video below.
Posted by
Whitney Thompson
on
February 10, 2012
Dr. Burgess appeared on Fox Business' Freedom Watch with Judge Andrew Napolitano to discuss the latest developments on the regulations that would require religious employers to offer contraceptive coverage. You can watch the video below.
Posted by
Whitney Thompson
on
February 07, 2012
Dr. Burgess appeared on Fox Business' Power and Money with David Asman to discuss the Keystone XL Pipeline. You can watch the video below.
Posted by
Whitney Thompson
on
February 07, 2012
By Rep. Michael Burgess (R-Texas) 02/07/12 06:45 PM ET Healthcare policy and the economic health and future of our nation are inextricably linked. We can no longer afford to make decisions on how healthcare is delivered and paid for without understanding how it affects jobs and economic growth. Congress hasn’t always followed this approach. In fact, we have enacted legislation that has stymied growth and prompted employers to either lay people off or curtail hiring. In medicine, it’s malpractice. In politics, it’s business as usual. With unemployment hovering above 8 percent, we no longer have the luxury of pursuing legislative and regulatory initiatives that stall or undermine job creation. We need policies that make sense for patients and add American workers to our economy. We should start at the same place physicians do when seeing a patient — diagnosis and testing. In fact, the area of genetic and genomic testing is a bright spot both medically and economically. This testing is saving lives, making healthcare more cost-efficient and, at the same time, creating jobs. There is a legitimate concern that Washington could snuff out this shining light. There is a movement to change the way genetic and genomic testing is regulated, bringing these services under the purview of the Food and Drug Administration — the same FDA that is widely criticized for slow review and approval processes, which has led to patients in other countries receiving new pharmaceutical and medical device innovations years before Americans. With the current FDA as gatekeeper, the rapid pace at which we’re breaking new ground would slow significantly. Another reason for not expanding the reach of the FDA is that most new genetic tests are developed in academic, hospital and independent labs, and are already regulated by another federal agency inside the same federal department. Giving new regulatory power to the FDA is redundant. Forcing clinical laboratories developing these tests to undergo the complicated and expensive FDA review process would keep genetic breakthroughs from making the leap from scientific discovery to healthcare delivery and could put these innovative companies out of business. A new study by the Battelle Institute found that genetic and genomic clinical laboratory testing generates 116,000 new jobs and $16.5 billion in annual economic growth. That means jobs within the laboratory sector but also related jobs in real estate, food establishments and retail sales. Every $1 of economic output by genetic and genomic laboratory testing creates $1.80 of related economic activity in other sectors. Battelle also points out that America is the global leader in this field. However, other nations are racing to compete. This brings us back to the drive to slap a redundant regulatory system onto this sector. If we slow down scientific progress through regulatory strangulation, those jobs and the economic vigor get shipped overseas. Improvements in genetic testing are enabling physicians to better target treatment to a patient’s unique genetic makeup, and we’re seeing markedly improved patient outcomes in a host of diseases and conditions, from childhood leukemia to cervical cancer to HIV. It would be unconscionable to deprive patients of new breakthroughs that can extend life and prevent pain. Likewise, it is senseless to see jobs disappear because of ill-conceived regulatory moves. These outcomes don’t have to happen. Let’s dispense immediately with the idea that the FDA needs even more responsibility. I have introduced legislation that would beef up the already existing Clinical Laboratory Improvement Amendments (CLIA) — the tools currently used to regulate clinical lab testing. A stronger CLIA would give the Centers for Medicare and Medicaid Services the authority to require that new genetic tests show evidence of clinical validity and the power to keep them off the market if they can’t demonstrate that value. Taking these steps protects patients while maintaining the flexibility to allow new, valuable tests to move rapidly from the laboratory bench to the bedside. It would ensure safety without erecting obstacles to stand in the way of life-enhancing innovation. It would also enable continued growth in one of the few sectors actually creating jobs and stimulating the economy. When I care for a patient, I not only treat the particular condition at hand, but also examine all factors that affect my patient’s ability to lead a long, productive life. Congress and federal agencies need to do the same, looking at healthcare policymaking through the prism of what it takes to give our economy a brighter, more dynamic future. Burgess, a physician, is the vice chairman of the Energy and Commerce subcommittee on Health.
Posted by
Whitney Thompson
on
February 06, 2012
Dr. Burgess spoke on the House Floor on what would be President Reagan's 101th birthday. You can watch the video below.
Posted by
Whitney Thompson
on
February 03, 2012
Dr. Burgess was featured in a Fox News report about the January unemployment numbers. You can watch the video below.
Posted by
Whitney Thompson
on
January 31, 2012
Dr. Burgess spoke on the House Floor about the Congressional Health Care Caucus' first event of 2012. The Health Care Caucus will hold briefings throughout the year about the road to the Supreme Court, as well as discuss future health care policy which will be determined by the Supreme Court's decision. You can watch the video below.
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