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How Donald Trump Could Disrupt the FDA



11/22/2016 5:40:10 AM

How Donald Trump Could Disrupt the FDA November 22, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – When Donald Trump is sworn in as president in January there are questions as to what may happen to various agencies in the nation’s capital, especially the U.S. Food and Drug Administration (FDA). There are some concerns that the Trump administration may look to dismantle the regulatory agency.

On the campaign trail, Trump called the FDA the “Food police,” when he criticized regulations placed on farmers and food inspections.

But it’s not only food regulations that Trump could challenge. Trump has also challenged some of the FDA’s oversight of regulating drug approval. In his 100 Day Plan, Trump said one FDA-specific reform he intends to undertake is to “cut the red tape at the FDA.” According to Trump’s plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.”

Trump has also called for easing restrictions on drugs that have been approved by foreign regulatory agencies to make them available in the United States, which would bypass the FDA’s regulatory authority over drugs in the U.S.

What Trump actually intends to do remains unknown. He could take aim at its budget to limit its powers—at a time when the federal agency is looking to increase the number of scientists working there. In June, FDA Commissioner Robert M. Califf posted a blog touting the mission of the regulatory agency and the need to hire additional staff to meet those needs. That posting at FDA.gov came four months after the federal agency submitted its budget requests to Congress that called for an 8 percent increase in hoped-for monies. In its request, the FDA cited a new food safety monitoring system, improved medical evaluations, and support for the cancer “moonshot” initiative supported by Vice President Joe Biden.
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Writing in Forbes, John LaMattina said he believes Trump will focus on "lowering the bar” for the approval of generic drugs. He said the backlog of generics waiting approval is “pretty large” and the “lack of generic alternatives for drugs like Daraprim has resulted in extensive price gouging.” Daraprim, of course, was the drug at the center of the Martin Shkreli scandal last year. The 65-year-old drug is used in the treatment of toxoplasmosis and does not have a generic. Shkreli’s Turing Pharmaceuticals acquired the drug and then increased the price by 5,000 percent. Another move LaMattina expects Trump to make is easing the approval of “off-label use of already approved drugs.”

“While FDA final approval will be ultimately required, the publication of clinical trials showing the benefit of the drug in a new indication will be sufficient to allow companies to discuss the new use of such a drug with physicians and other healthcare professionals,” La Mattina said.

Another move Trump could make is to expand “right to try” rules, StatNews reported this morning. Right to try rules would give terminally ill patients access to unapproved therapies that have passed basic safety requirements. Citing a report from Holland & Knight, a law firm specializing in health care, StatNews said Vice President-elect Mike Pence has been an advocate of “right to try” rules and pushed for it in Indiana during his tenure as governor. StatNews said the right to try movement has been successful in 31 states, but it raises concerns over whether state governments have authority over the FDA—something that FDA leadership does not want.

It’s a concern shared by other advocacy groups. In an interview with Focus, the publication of the Regulatory Affairs Professional Society, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, noted that Trump has been focused on the economy.

“FDA regulates a lot of consumer spending and those industries produce a lot of high-paying jobs. We hope they see that this agency is in the interest of the economy, and that disrupting FDA is not a way to boost the economy,” Grossman said.


Read at BioSpace.com


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