Thursday, January 18, 2018

Dr. Manny Alvarez: FDA makes incredible progress under Trump administration, approving new life-saving drugs


Without great fanfare and out of the glare of the media spotlight, the U.S. Food and Drug Administration (FDA) is making enormous progress under the Trump administration in approving new medications to help us live healthier and longer.
In fact, the FDA today is operating more efficiently and effectively than it has in the past 20 years. This is good news for us all, because undoubtedly some of us will benefit from the new drugs being approved more rapidly than before.
Among its many duties, the FDA regulates medical innovation and the creation of new therapies in the biotech sector. Remarkably, the agency increased the number of new drugs it allowed on the market by 20 percent in 2017 – an unprecedented increase.
Take, for example, Roche’s new multiple sclerosis drug Ocrevus. Multiple sclerosis is a chronic, inflammatory autoimmune disease that disturbs communication between the brain and the rest of the body, affecting 2.5 million Americans. The approval of Ocrevus in March provided great hope for those suffering from the most debilitating forms of the disease.
As a practicing doctor for over 30 years, I have witnessed firsthand the speed and intensity with which other countries – especially in Europe – were outpacing the United States when it came to making often life-saving drugs available to patients.
We’ve also seen an influx of cancer immunotherapy drugs to stimulate the body’s own immune system to attack cancer cells. These drugs are used in place of classic chemotherapy and radiation cocktails that can have unwanted and lasting side effects. Many of the world’s leading cancer doctors consider immunotherapy to be the future of cancer treatment, and there is a lot of research now to backup those theories.
As a practicing doctor for over 30 years, I have witnessed firsthand the speed and intensity with which other countries – especially in Europe – were outpacing the United States when it came to making often life-saving drugs available to patients. Plagued by a lack of leadership and an embedded bureaucracy that did not allow for expedited reviews, the FDA has for decades been lagging.
That’s why I think President Trump’s appointment of Scott Gottlieb as commissioner of the FDA was quite brilliant, paving the way for progress.
Under Gottlieb, we are beginning to see an increase in competition that is expected to drive down drug prices, just as President Trump promised on the campaign trail. In addition, this new approach is creating incentives for researchers in the private sector to bring new therapies and improved therapies to the market.
And that’s something we can all get behind.
Dr. Manny Alvarez serves as Fox News Channel's senior managing health editor. He also serves as chairman of the department of obstetrics/gynecology and reproductive science at Hackensack University Medical Center in New Jersey. For more information on Dr. Manny's work, visit AskDrManny.com.

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