DSPA And Affordable Care Act Repeal

At the time of this report, thirty States have held Republican Presidential and Congressional primary elections. As the democratic process works, every four years, campaigns and elections take precedence over the legislative work of Congress. This is good news for those average Americans who want less Federal government control imposed upon them by Congressional bills that do nothing more than create new and ever-expanding restrictions over our lives and individual freedoms

The House Republican party majority is looking at the big public-policy issues but at the expense of equally important, “downscale” issues such as reforming the Food and Drug Administration (FDA) and the NHF’s legislative goal (H.R.3380) to amend the Dietary Supplement Health and Education Act (DSHEA) by advancing the 1994 DSHEA grandfathering date forward from October 15, 1994 to January 1, 2007.  This change would encompass and protect thousands of “new” dietary-supplement ingredients that are already safe but that the FDA would drive from the marketplace with the burdensome new testing requirements in its proposed draft Guidance for New Dietary Ingredients for Supplements.           

As previously reported, Senators Tom Harkin and Orrin Hatch, the authors and defenders of the Dietary Supplement Health and Education Act of 1994 (DSHEA), sent a letter to the FDA Commissioner seeking a meeting between FDA and their staffs to explain the Agency’s unprecedented misinterpretations of the DSHEA law in the Guidance. The NHF and a coalition of industry representatives met with staff and asked for and got the letter to the FDA. The FDA communicated the message back to the Senators to forget it. Following this, in February, at the request of the NHF, Congressman Dan Burton (R-IN) – who introduced H.R.3380 (the Dietary Supplement Protection Act (DSPA)) at the request of the NHF – and Jason Chaffetz (R-UT) sent a similar letter to FDA Commissioner Margaret Hamburg, M.D. The Burton/Chaffetz letter forewarns that if the FDA does not withdraw the Guidance, legislation will be considered. That legislation is our H.R.3380. This Bill would exempt many thousands of supplements not just from this Guidance but also from future burdensome and unnecessary FDA regulatory policies. It would drastically close the window against which unjustifiable bureaucratic actions could be taken in the future. It does not impact the other post-marketing regulations for protecting consumer safety.

These letters and the FDA’s rejections – and most likely rejection of the Burton-Chaffetz request – are the start of an extended negotiation process with the FDA. The NHF initiated the introduction of H.R.3380 with the intent to win a clear victory and not simply engage in a “begging” process that will neither benefit dietary-supplement consumers nor the industry in the long term. As the leading organization in the health-freedom community, we know all to well the history of what has happened to health freedom and will not stand by to witness it again. Pro-liberty advocates and supplement consumers need to proactively lobby their Congressional Representatives to cosponsor H.R.3380. This can be done at the NHF homepage at www.thenhf.com. People can also send a letter to their Representatives at http://www.thenhf.com/DSPA.

The Affordable Care Act – AKA Obamacare 

There will be more details in the public-news domain, but probably not a final decision from the Supreme Court on Obamacare and the individual mandate, State Medicaid spending, and related matters concerning the constitutionally of the law. However, there are two other matters that were mandated in Obamacare that are flying under the radar of national media coverage.  These relate to: (1) onerous Federal control; and (2) “free” access to health-care services in the future. Neither of these involves the issue with the mandated Obamacare insurance coverage of contraception services and products by religious organizations. 

The Affordable Care Act established another bureaucratic nightmare called the Independent Payment Advisory Board (IPAB).  IPAB’s purported purpose is to reduce Medicare spending. The Medicare IPAB consists of fifteen unelected bureaucrats, nominated by the President, and paid $165,300 a year to serve six-year terms on the Board. If Medicare spending goes over an arbitrary target, the Board has been given the authority to submit a proposal to Congress to reduce Medicare’s growth rate in spending. These recommendations will automatically go into effect unless Congress passes legislation that achieves the same amount of savings. When testifying before Congress, Barack Obama’s Secretary of the Department of Health and Human Services, Kathleen Sebelius, admitted that the cost-reduction recommendations of the IPAB would lead to less access to medical treatments for Medicare-aged persons. The IPAB may not be able to directly ration care, but cutting doctor and hospital reimbursements to the point that doctors can no longer see Medicare patients would result in de-facto rationing. A bill to repeal the authority of the IPAB, H.R.452, was introduced by House Republicans, and amended to H.R.5, which passed the House by a vote of 223 For and 181 Against, on March 23rd. The Democratic-controlled Senate is not expected to consider, much less vote on, the Bill.

The Affordable Care Act also established the Federal Coordinating Council for Comparative Effectiveness Research. The Council is composed of 15 Senior Federal Officers from seven different Federal agencies, including the FDA and Medicare among others. No fewer than 50% of the senior Federal-agency representatives must be physicians and have already been appointed by Barack Obama. The “Council of Bureaucrats” has the authority to coordinate comparative effectiveness health research and make decisions based on such comparisons. More than $1 billion has been allocated for funding studies and grants on which medical treatments are deemed to be worthy of insurance coverage and which are ineffective based on such factors as disease prevalence and conditions for which there are variations in the delivery of care. (See HFN, 26:3 & 26:4). 

The Patient-Centered Outcomes Research Institute (PCORI), a not-for-profit organization affiliated with the Council, was created in 2010. The goal of its studies was to give patients and physicians evidence about which medical-treatment options work best for most people for specific segments of the population. In January of this year, the PCORI released a 22-page plan that explained the priorities of its research agenda. Now, the comments filed by an alliance of patient and industry groups have uniformly criticized the plan as too vague to have any meaningful impact on patient and clinician decision-making.

The NHF continues to raise freedom-of-choice concerns with these Federal bureaucratic panels and their delegated authority to make determinations of the clinical effectiveness and cost of medical treatments and procedures, prescription drugs, and medical devices. In other words, all forms of medical care practiced in our country and patient and physician choices become limited. The use of dietary supplements, herbal products, and other alternative forms of medical treatments will come under assault by conventionally trained, Federal bureaucratic physicians. Obamacare has not yet been judged to be unconstitutional, but there are other health-freedom stealing provisions in the law. Unless this law is repealed in its totality, Federal bureaucrats will control our medical-care options and access in the future.  It is not a pretty picture. 

At the time of this report, thirty States have held Republican Presidential and Congressional primary elections. As the democratic process works, every four years, campaigns and elections take precedence over the legislative work of Congress. This is good news for those average Americans who want less Federal government control imposed upon them by Congressional bills that do nothing more than create new and ever-expanding restrictions over our lives and individual freedoms

 

The House Republican party majority is looking at the big public-policy issues but at the expense of equally important, “downscale” issues such as reforming the Food and Drug Administration (FDA) and the NHF’s legislative goal (H.R.3380) to amend the Dietary Supplement Health and Education Act (DSHEA) by advancing the 1994 DSHEA grandfathering date forward from October 15, 1994 to January 1, 2007.  This change would encompass and protect thousands of “new” dietary-supplement ingredients that are already safe but that the FDA would drive from the marketplace with the burdensome new testing requirements in its proposed draft Guidance for New Dietary Ingredients for Supplements.

           

As previously reported, Senators Tom Harkin and Orrin Hatch, the authors and defenders of the Dietary Supplement Health and Education Act of 1994 (DSHEA), sent a letter to the FDA Commissioner seeking a meeting between FDA and their staffs to explain the Agency’s unprecedented misinterpretations of the DSHEA law in the Guidance. The NHF and a coalition of industry representatives met with staff and asked for and got the letter to the FDA. The FDA communicated the message back to the Senators to forget it. Following this, in February, at the request of the NHF, Congressman Dan Burton (R-IN) – who introduced H.R.3380 (the Dietary Supplement Protection Act (DSPA)) at the request of the NHF – and Jason Chaffetz (R-UT) sent a similar letter to FDA Commissioner Margaret Hamburg, M.D. The Burton/Chaffetz letter forewarns that if the FDA does not withdraw the Guidance, legislation will be considered. That legislation is our H.R.3380. This Bill would exempt many thousands of supplements not just from this Guidance but also from future burdensome and unnecessary FDA regulatory policies. It would drastically close the window against which unjustifiable bureaucratic actions could be taken in the future. It does not impact the other post-marketing regulations for protecting consumer safety.

 

These letters and the FDA’s rejections – and most likely rejection of the Burton-Chaffetz request – are the start of an extended negotiation process with the FDA. The NHF initiated the introduction of H.R.3380 with the intent to win a clear victory and not simply engage in a “begging” process that will neither benefit dietary-supplement consumers nor the industry in the long term. As the leading organization in the health-freedom community, we know all to well the history of what has happened to health freedom and will not stand by to witness it again. Pro-liberty advocates and supplement consumers need to proactively lobby their Congressional Representatives to cosponsor H.R.3380. This can be done at the NHF homepage at www.thenhf.com. People can also send a letter to their Representatives at http://www.thenhf.com/DSPA.

 

The Affordable Care Act – AKA Obamacare

 

There will be more details in the public-news domain, but probably not a final decision from the Supreme Court on Obamacare and the individual mandate, State Medicaid spending, and related matters concerning the constitutionally of the law. However, there are two other matters that were mandated in Obamacare that are flying under the radar of national media coverage.  These relate to: (1) onerous Federal control; and (2) “free” access to health-care services in the future. Neither of these involves the issue with the mandated Obamacare insurance coverage of contraception services and products by religious organizations.

 

The Affordable Care Act established another bureaucratic nightmare called the Independent Payment Advisory Board (IPAB).  IPAB’s purported purpose is to reduce Medicare spending. The Medicare IPAB consists of fifteen unelected bureaucrats, nominated by the President, and paid $165,300 a year to serve six-year terms on the Board. If Medicare spending goes over an arbitrary target, the Board has been given the authority to submit a proposal to Congress to reduce Medicare’s growth rate in spending. These recommendations will automatically go into effect unless Congress passes legislation that achieves the same amount of savings. When testifying before Congress, Barack Obama’s Secretary of the Department of Health and Human Services, Kathleen Sebelius, admitted that the cost-reduction recommendations of the IPAB would lead to less access to medical treatments for Medicare-aged persons. The IPAB may not be able to directly ration care, but cutting doctor and hospital reimbursements to the point that doctors can no longer see Medicare patients would result in de-facto rationing. A bill to repeal the authority of the IPAB, H.R.452, was introduced by House Republicans, and amended to H.R.5, which passed the House by a vote of 223 For and 181 Against, on March 23rd. The Democratic-controlled Senate is not expected to consider, much less vote on, the Bill.

 

The Affordable Care Act also established the Federal Coordinating Council for Comparative Effectiveness Research. The Council is composed of 15 Senior Federal Officers from seven different Federal agencies, including the FDA and Medicare among others. No fewer than 50% of the senior Federal-agency representatives must be physicians and have already been appointed by Barack Obama. The “Council of Bureaucrats” has the authority to coordinate comparative effectiveness health research and make decisions based on such comparisons. More than $1 billion has been allocated for funding studies and grants on which medical treatments are deemed to be worthy of insurance coverage and which are ineffective based on such factors as disease prevalence and conditions for which there are variations in the delivery of care. (See HFN, 26:3 & 26:4).

 

The Patient-Centered Outcomes Research Institute (PCORI), a not-for-profit organization affiliated with the Council, was created in 2010. The goal of its studies was to give patients and physicians evidence about which medical-treatment options work best for most people for specific segments of the population. In January of this year, the PCORI released a 22-page plan that explained the priorities of its research agenda. Now, the comments filed by an alliance of patient and industry groups have uniformly criticized the plan as too vague to have any meaningful impact on patient and clinician decision-making.

The NHF continues to raise freedom-of-choice concerns with these Federal bureaucratic panels and their delegated authority to make determinations of the clinical effectiveness and cost of medical treatments and procedures, prescription drugs, and medical devices. In other words, all forms of medical care practiced in our country and patient and physician choices become limited. The use of dietary supplements, herbal products, and other alternative forms of medical treatments will come under assault by conventionally trained, Federal bureaucratic physicians. Obamacare has not yet been judged to be unconstitutional, but there are other health-freedom stealing provisions in the law. Unless this law is repealed in its totality, Federal bureaucrats will control our medical-care options and access in the future.  It is not a pretty picture.