Has the growing reliance of the U.S. Food and Drug Administration on industry user fees changed how the pharmaceutical and medical device industries influence FDA regulation? A review in The New England Journal of Medicine charts changing industry influence from the Prescription Drug User Fee Act (PDUFA)of 1992 to the recent sixth re-authorization of PDUFA by President Trump this year. The authors conclude that although 25 years of industry funding have shortened regulatory timelines, the user-fee model has fundamentally changed the way the FDA interacts with the drug industry. These changes may increase the risk that unsafe or ineffective drugs or medical devices enter the market.
A Washington Post 60 minutes investigative expose revealed that Trump’s nominee to head the Drug Enforcement Agency, Tom Marino, a Republican from Pennsylvania had led a successful effort in the House of Representatives to strip the DEA of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets. The revelation forced Marino to withdraw and Trump to start again in pursuing his long-promised campaign against opioid misuse. The story suggests two lessons. First, corporate influence in Congress is so strong that even in an opioid epidemic, the drug industry can persuade Congress to deregulate to protect its profits. Second, the power of investigative journalism continues to be an important check on abuses of authority.
During the campaign, President Donald Trump threatened to withdraw from NAFTA, calling it “a disaster since the day it was devised,” write Alyshia Galvez and Nicholas Freudenberg in an op ed in the Dallas Morning News. But last week, he said he will “bring NAFTA up to date through renegotiation.” However, neither Trump nor those on either side of the trade wars has given any hint that they know about one of NAFTA’s most distressing consequences: its adverse impact on the health of the Mexican people. For those who believe that fair trade agreements can benefit all, the goal should be a renegotiated NAFTA that puts the well-being of all North Americans first. A trade agreement that favors sustainable agriculture, labor mobility and a food system oriented toward health — not corporate profits — would be good for us all.
President Trump met with leaders of some of the world’s biggest pharmaceutical companies Tuesday and emphasized the need to lower “astronomical” drug prices, decrease regulations and bring more drug manufacturing into the United States, reports The Washington Post. Trump offered no specific policies, but mentioned increasing competition and “bidding wars” as a way to bring down prices. In the past, he has lashed out at the pharmaceutical industry for “getting away with murder” and threatened to use the government’s bargaining power to force down drug prices for programs like Medicare.
Public Citizen Response
In a response to this proposal, Michael Carome, Director of Public Citizen’s Health Research Group wrote:
President Donald Trump’s preposterous promise to pharmaceutical company CEOs to slash U.S. Food and Drug Administration (FDA) regulations by 75 to 80 percent would, if fulfilled, fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements, and dangerous tobacco products, among other things. The end result would be countless preventable deaths, injuries and illnesses across the U.S. Trump’s horrifying proposal reflects utter ignorance about the FDA’s essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people.
With lawmakers bearing down on drug and device companies over prices, the industry can’t afford to lose any friends on Capitol Hill, writes STAT, an online news service on the medical industry. And when it comes to medical devices, the industry might not have a better friend than Minnesota Congressman Erik Paulsen. Paulsen, a four-term Republican, has long been device makers’ “go-to guy” in Washington, helping secure a two-year delay of the Affordable Care Act’s tax on medical devices and pursuing reforms that could help the industry. But this year, Donald Trump is threatening to drag Paulsen down. So device makers are stepping in and pouring money into his campaign to save him.