What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies

However, while Trump has called for a reduction of federal regulations in general, it remains to be seen how he will deal with the US Food and Drug Administration (FDA).

Steven Grossman, JD, Deputy Executive Director of the Alliance for a Stronger FDA, told Focus in a phone interview:  “Our positioning is that Trump has been focused on jobs and the economy, and 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.”

Regardless of what happens at FDA, the biopharmaceutical industry will always need to continue to find ways to raise new funds and develop new treatments to stay afloat.

Ron Cohen, president and CEO of Acorda Therapeutics and chairman of industry group BIO, explained to Focus:  “The fundamental challenges the industry has been grappling with have not changed.  We still need to ensure incentives for the massive, at risk investments required to create innovative, more effective medicines, while still ensuring that everyone who needs a medicine has access to it.  That’s irrespective of who is in the White House.”

Obamacare Repeal

According to Donald Trump’s Contract with the American Voter laying out his plans for his first 100 days in office, a repeal and replacement for 2010’s Patient Protection and Affordable Care Act (ACA), also known as Obamacare, seems highly likely.  “Reforms will also include cutting the red tape at the FDA:  there are over 4,000 [generic] drugs awaiting approval, and we especially want to speed the approval of life-saving medications,” the contract reads.  The ACA repeal would also have implications for both the pharmaceutical and device industries.  For instance, a repeal could shift the way drug manufacturers and distributors submit drug sample information to FDA, and on which FDA has issued draft guidance.

The ACA also created an abbreviated licensure pathway for FDA to approve biosimilars and interchangeable biosimilars, though it remains to be seen how this pathway would or would not be reformed by such a repeal and replacement plan.

Maxim Jacobs, Director of Healthcare Research, North America for Edison Investment Research told Focus:  “There really is no indication he is in bed with pharma companies.  I would think the biosimilar pathway might even get easier.”

Trump has also called for repealing the 2.3% medical device tax, which was suspended in 2016 and 2017 but was set to go back into effect in 2018.  Larry Biegelsen, senior analyst at Wells Fargo, said Trump’s win makes such a repeal more likely and could mean more industry-friendly leadership at FDA and CMS.

Device industry group AdvaMed’s President and CEO Scott Whitaker told Focus in a statement:  “In the coming year, policymakers will be dealing with a number of important policy issues, including authorization of the latest Medical Device User Fee agreement to continue improving the FDA regulatory process, repeal of the medical device tax, and ensuring that the coverage process allows patient access to the latest innovations.  These have been and will always be bipartisan issues.”

Campaign to Reality

In his campaign, Trump said he is interested in bringing down prescription drug prices by allowing the import of drugs from other countries and allowing Medicare to directly negotiate on drug prices — both of which are opposed by the drug lobby, PhRMA, though the group seems eager to work with Trump.

PhRMA president and CEO Steve Ubl told Focus in a statement:  “We look forward to working with the new administration, as well as members of Congress on both sides of the aisle to advance pragmatic solutions that enhance the private market, improve patient access to care and foster the development of innovative medicines.

“We are in a new era of medicine with treatments and cures that are completely transforming the fight against debilitating diseases.  To ensure this innovation continues, we need to modernize the U.S. Food and Drug Administration (FDA) to keep pace with scientific advances, remove regulatory barriers that make it harder to move to a value-driven health care system and focus on making better use of the medicines we have today.”

This removal of regulatory barriers can also be seen in the latest iteration of the 21st Century Cures bill that is still being negotiated in Congress and which Senate majority leader Mitch McConnell said yesterday remains a top priority.  Also on tap between now and Trump’s inauguration is work on re-authorizing the rare pediatric disease priority review voucher program, which rewards companies with vouchers worth millions for developing new rare pediatric disease treatments.

FDA Changes

In addition to speeding up drug approvals and cutting red tape at FDA, in September, a Trump campaign fact sheet later removed from the website said:  “The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food.  “The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperatures, and even what animals may roam which fields and when.  It also greatly increased inspections of food ‘facilities,’ and levies new taxes to pay for this inspection overkill,” the fact sheet continued.

But whether that rhetoric was just for the campaign remains to be seen.

FDA spokesman Jason Young told Focus:  “We don’t really have anything to share at this time.”

Grossman also told Focus: “I think the question is can they be persuaded that a more gentle hand is needed with FDA.”

REFERENCE:  RAPS Regulatory Focus; 10 NOV 2016; Zachary Brennan

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