Does Trump pose a threat to the FDA's future?
President Trump’s first month in office made headlines across the industry just as it did in the wider media. Promises to play hardball with big pharma featured prominently throughout his presidential campaign, and his actions so far suggest he has no intention of backing off.
On 31 January, Trump met with a number of top pharma execs at the White House to discuss the matters of drug pricing and the US regulatory process; among the attendees were Stephen Ubl, CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), Novartis Chief Executive Joe Jimenez, MSD CEO Ken Frazier, Eli Lilly CEO Dave Ricks and Executive Chairman of Celgene Robert Hugin.
Only weeks earlier, Trump had called out big pharma on pricing issues, claiming that they had been “getting away with murder”, and threatened to take action on the matter. He used the meeting as an opportunity to reiterate this sentiment, calling drug prices “astronomical”, and stating, “We have to get prices down for a lot of reasons. We have no choice.”
The pharma industry has been consistently struggling with the negative strain of the pricing debate for the better part of a year, bubbling to the surface in the summer of last year with the Mylan EpiPen pricing scandal, and sustained in national conversation throughout the presidential race. In an attempt to neutralise public ire, the PhRMA last month launched the multi-million dollar media campaign GOBOLDLY to stress the benefits of biopharmaceutical innovation and developments in order to win back waning favour.
Trump added that his administration would be “changing a lot of the rules”, and pledged to bring down the prices of Medicare and Medicaid, and called for more pharma manufacturing to be relocated back onto US soil.
Perhaps most significantly, in a bid to speed up the approval of new life-saving drugs, he also called for less regulation: “We’re also going to be streamlining the process,” he said, “so that from your standpoint when you have a drug that you can actually get it approved instead of waiting many, many years. We’re going to get the approval process much faster.” Trump has said he aims to repeal 75% of all federal regulation, which in total corresponds to over 178,000 pages of rules.
One day prior to the meeting, Trump had signed, by executive order, new “one in, two out” regulatory legislation which quickly caused concern and alarm over its potential impact on the country's regulatory system and the FDA. The order calls for government agencies to pull two existing regulations for every new regulation they wish to implement, as well as enforcing a strict requirement for the cost of all new regulations to be “no greater than zero” unless authorised by the Office of Management and Budget (OMB) or required by law.
White House Press Secretary Sean Spicer called the order “the most significant administrative action in the world of regulatory reform” since the Reagan administration.
However, critics of the move were quick to argue that an abundance of regulations is not the core problem with the US system; the bigger problem is that many regulations serve little to no purpose, either implementing spending constraints, correcting errors, reducing burdens or even simply deregulating existing regulations.
Industry figures were also alarmed by the lack of detail provided in the order, leaving them unsure of how exactly it will come into effect or how it will impact a public health-focused organisation like the FDA. Foremost among these concerns is the fact that, because of the nature of the FDA and the breadth of the legislation it enforces, in addition to the fact that regulations submitted are in no way necessarily related, for it to enact a new regulation it would need to potentially cut two completely unrelated ones, creating an almost one step forward, two steps back approach.
The order even affects FDA guidance documents, which could have huge implications on the pharma companies which depend on said guidance when it comes to the authorisation of new products.
Just a week earlier, Trump had flexed his executive order powers once more to call for a federal hiring freeze, causing further concern over the potential pressures such a move could place on the FDA, an organisation already suffering from tight deadlines and understaffing; at the end of last year, it was reported that the association was struggling to fill over 700 vacant roles.
Perhaps the biggest impact of the order is how it could affect Obama’s 21st Century Cures Act, a $6.3 billion bill signed by the former President in December dedicated to expediting the approval of new medical treatments. Already in the process of dismantling the firmly-established Affordable Care Act, Trump’s new legislation could put the brakes on the just-months-old bill while it is still in its infancy; the 1,000 page document is heavily entwined with the FDA’s current practices, and Trump’s regulatory shake-up could create sizeable obstacles for it to overcome in its implementation.
The enactment of the new order is currently under review by Mark Sandy, acting Director of the OMB. However, since the order was given, it has immediately become the target of several lawsuits asserting that the President has exceeded his Constitutional authority. The Natural Resources Defense Council (NRDC), the Communications Workers of America (CWA) and Public Citizen (PC) have all sought to block the order on the grounds that it is ill-considered, “irrational” and would pose serious risks to American citizens.
“This order means that the asbestos workplace standard, for example, could be discarded in order to adopt safeguards for nurses from infectious diseases in their workplaces,” stated UWC President Chris Shelton, requiring workers to “trade off one set of job, health and safety protections in order to get protection from another equally dangerous condition.”
“President Trump’s order would deny Americans the basic protections they rightly expect,” added NRDC President Rhea Suh. “New efforts to stop pollution don’t automatically make old ones unnecessary…This order imposes a false choice between clean air, clean water, safe food and other environmental safeguards.”
Press Secretary Spicer rebuked the legal challenges as baseless, wildly speculative and “subjective at best”.
“The bottom line is that overregulation has stemmed economic growth and job creation,” he said. “Reviewing those to make sure that they are meeting their intent and not siphoning job creation at the expense of whatever they were intended to do is something that should be ... welcomed by everybody."
As part of the next step in Trump’s FDA overhaul, he intends to appoint a new leader for the association, a candidate he has described as “a fantastic person”. It is widely believed that former Health and Human Services official Jim O’Neill is the President’s top pick, a decision that has unsurprisingly drawn fire; O’Neill has no medical background and has argued that it is not necessary for companies to prove their drugs work before selling them.
While Trump’s disruptive shake-ups appear to place the FDA in peril, it will become evident in the coming months and years whether his extreme deregulation measures reap rewards for patients in dire need of access to life-saving drugs.