President Donald Trump signed an executive order this week that could have direct implications for the FDA.
President Donald Trump signed an executive order this week that could have direct implications for the FDA. Trump also met with several pharmaceutical executives — from companies such as Eli Lilly, Novartis, Amgen, and Merck – to propose his plans for the industry.
Trump claimed throughout his campaign that excessive government regulations got in the way of speedier drug approvals, and vowed to reduce costs. The newly signed executive order, directing federal agencies to eliminate 2 regulations for every new regulation that is issued, is part of Trump’s action toward accelerating FDA drug approvals.
Among select topics at his meeting with top pharma CEOs, Trump focused on cutting FDA regulations to bring pharmaceutical manufacturing operations back to the United States. He added that as much as 80% of regulations are unnecessary. The executive order directs federal agencies, including the FDA, to cut down on regulations, which Trump foresees will facilitate drug manufacturing and jobs. Trump stated in the meeting, “So we have to get your companies back here. We have to make progress back. We’re going to get rid of a tremendous number of regulations.”
The president also promised to lower taxes and drug prices in the industry. Despite previously slamming drug companies, Trump’s statement in the meeting was more tempered, telling pharma executives that, “The US drug companies have produced extraordinary results for our country, but the pricing has been astronomical for our country.”
Stephen J. Ubi, president and chief executive officer of PhRMA, noted in a statement that the meeting with President Trump was positive and productive. “The current system needs to evolve to enable the private sector to lead the move to a value-driven health care system,” Ubi said, “To do this, we need to reform existing laws and regulations that are currently preventing private companies from negotiating better deals and paying for medicines based on the value they provide to patients and our health systems.”
However, not everyone was impressed. Dr. Michael Carome, Director of Public Citizen’s Health Research Group, released a statement regarding Trump’s plan as a danger to public health.
“President Donald Trump’s preposterous promise to the pharmaceutical company CEOs to slash the US FDA regulations by 75 to 80% would, if fulfilled, fundamentally destroy the ability of the agency to protect patients and consumers…” Dr. Carome said in a news release. Dr. Carome said that Trumps’ proposal “demonstrates his commitment to placing corporate profits above protecting the safety of the American people.”
Despite the recently-signed executive order, the Trump administration has not yet provided key details on how the regulatory reform will be implemented.
PhRMA CEO Statement Following Meeting with President Trump [news release]. PhRMA’s website. http://catalyst.phrma.org/phrma-ceo-statement-following-meeting-with-president-trump. Accessed Feb. 1, 2017.
President Donald J. Trump Works To Make Drugs More Affordable, Create Jobs [news release]. Washington DC. The White House’s website. https://www.whitehouse.gov/the-press-office/2017/01/31/president-trump-works-make-drugs-more-affordable-create-jobs. Accessed Feb. 1, 2017.
Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs. Washington DC. The White House’s website. https://www.whitehouse.gov/the-press-office/2017/01/30/presidential-executive-order-reducing-regulation-and-controlling. Accessed Feb. 1, 2017.
Trump Proposal to Eviscerate FDA Regulations Would Endanger Public Health [news release]. Public Citizen’s website. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=10142. Accessed Feb. 1, 2017.