- Nov 26, 2011
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If Newt Gingrich is appointed by Trump to be the Secretary of Health and Human Services (HHS), invest in Big Pharma, folks. There will be big money to be made. Newt will shake up the FDA, big time.
Here is Newt in his own words about the FDA three years ago: Six Health-Care Demands, by Newt Gingrich, National Review
The FDA is a major prison guard stopping the breakout in health. It must be overhauled. Its standards for evaluating new treatments and therapies are completely unsuited for the age of regenerative medicine, and the cost of getting these treatments approved in the United States will be absurdly high even compared with the absurdly high cost of getting normal drugs approved. There is a grave danger that breakthroughs in regenerative medicine will be made in American laboratories and then be introduced to patients in China, India, Japan, and Europe because FDA approval is too time-consuming and too expensive.
Furthermore, FDA reform must address the agency’s lethally low tolerance for risk. In addition to allowing Americans to obtain non-FDA-approved treatments with informed consent, the agency should begin to loosen its requirements in an age when we could track side effects and bad results in real time and make changes based on immediate data. Perhaps good preliminary results should be sufficient for doctors to begin prescribing many treatments as long as patients are connected to the constant monitoring technologies that Dr. Eric Topol described.
Gingrich has been stumping this idea since his days as House Speaker. Here's a 1995 Mother Jones article which provides the Left's fears about Newt's plans: 10 Ways the Republicans Will Change Your Life
Probably no federal agency has been more criticized by the Republicans than the Food and Drug Administration. Gingrich called it the "number one job-killer" in the country, and the sentiment is widely echoed among his followers. Their argument: The FDA moves at a glacial pace; it's hostile to business; and it stifles competition and free enterprise. The truth is, the FDA isn't perfect, but under Commissioner David Kessler it has been activist, diligent, scrupulous, and responsive to the safety of consumers over the demands of business.
Gingrich has actually called for replacing the FDA with a "council of entrepreneurs," claiming that the market will take care of any poisonous foods or drugs after the fact through legal actions. In other words, if your child is born deformed by a drug such as thalidomide--the drug that prompted the FDA to require safety testing--you can sue, and future companies will pay attention. (But note change #10, which will make your lawsuit a lot more difficult.)
Because the Republicans don't want to seem anti-consumer, the attack on the FDA will be subtle. First off, the FDA's budget will be cut. ("Their appropriation is going to get destroyed," says one administration source.) With less money, the FDA will conduct fewer investigations. Ironically, it may also take longer to approve new drugs.
And there are other ways to slow the FDA's work. "Anytime there's an enforcement action or any policy or regulation deemed controversial in the eyes of Republicans, they can slam the FDA with a massive document subpoena and hold hearings on it," the source says. "It's an incredible waste of time."
One casualty: any plan to regulate tobacco as a drug, which the FDA was promoting in the last Congress. Forget it.
Discuss.
Here is Newt in his own words about the FDA three years ago: Six Health-Care Demands, by Newt Gingrich, National Review
The FDA is a major prison guard stopping the breakout in health. It must be overhauled. Its standards for evaluating new treatments and therapies are completely unsuited for the age of regenerative medicine, and the cost of getting these treatments approved in the United States will be absurdly high even compared with the absurdly high cost of getting normal drugs approved. There is a grave danger that breakthroughs in regenerative medicine will be made in American laboratories and then be introduced to patients in China, India, Japan, and Europe because FDA approval is too time-consuming and too expensive.
Furthermore, FDA reform must address the agency’s lethally low tolerance for risk. In addition to allowing Americans to obtain non-FDA-approved treatments with informed consent, the agency should begin to loosen its requirements in an age when we could track side effects and bad results in real time and make changes based on immediate data. Perhaps good preliminary results should be sufficient for doctors to begin prescribing many treatments as long as patients are connected to the constant monitoring technologies that Dr. Eric Topol described.
Gingrich has been stumping this idea since his days as House Speaker. Here's a 1995 Mother Jones article which provides the Left's fears about Newt's plans: 10 Ways the Republicans Will Change Your Life
Probably no federal agency has been more criticized by the Republicans than the Food and Drug Administration. Gingrich called it the "number one job-killer" in the country, and the sentiment is widely echoed among his followers. Their argument: The FDA moves at a glacial pace; it's hostile to business; and it stifles competition and free enterprise. The truth is, the FDA isn't perfect, but under Commissioner David Kessler it has been activist, diligent, scrupulous, and responsive to the safety of consumers over the demands of business.
Gingrich has actually called for replacing the FDA with a "council of entrepreneurs," claiming that the market will take care of any poisonous foods or drugs after the fact through legal actions. In other words, if your child is born deformed by a drug such as thalidomide--the drug that prompted the FDA to require safety testing--you can sue, and future companies will pay attention. (But note change #10, which will make your lawsuit a lot more difficult.)
Because the Republicans don't want to seem anti-consumer, the attack on the FDA will be subtle. First off, the FDA's budget will be cut. ("Their appropriation is going to get destroyed," says one administration source.) With less money, the FDA will conduct fewer investigations. Ironically, it may also take longer to approve new drugs.
And there are other ways to slow the FDA's work. "Anytime there's an enforcement action or any policy or regulation deemed controversial in the eyes of Republicans, they can slam the FDA with a massive document subpoena and hold hearings on it," the source says. "It's an incredible waste of time."
One casualty: any plan to regulate tobacco as a drug, which the FDA was promoting in the last Congress. Forget it.
Discuss.
