A year ago, Trump infamously claimed that pharmaceutical companies were “getting away with murder” but his State of the Union rhetoric implied a shifting of blame away from the industry.
Trump’s SOTU comments on drug prices:
“One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”
While Trump continues to reiterate his desire for lower drug prices, the conversation has seemingly shifted away from pharma companies and more towards out-of-pocket costs, in which health insurers and pharmacy benefits managers (PBMs) are feeling the greatest scrutiny.
Eli Lilly CEO Dave Ricks seemingly agrees, though he immediately spoke out after the speech, clarifying with CNBC that the drug pricing problem is an insurance-design issue, noting his disapproval with a health care system dominated by suppliers incentivized by profit-making.
Pharma trade organization, PhRMA, has launched a new consumer-facing website designed to provide consumers with “easy-to-understand information about the cost and coverage of medicines.” It lays out its opinion clearly: “More than one-third of a medicine’s list price is often rebated back to middlemen, like insurers and pharmacy benefit managers. These discounts and rebates create savings of more than $100 billion, but insurers don’t always share these savings with patients.”
Trump’s SOTU comments on the FDA approval process:
“To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history.
We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives.
People who are terminally ill should not have to go from country to country to seek a cure -- I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”
It is true that 2017 was a record year in general for the FDA. Under the leadership of FDA’s commissioner, Scott Gottlieb, the agency has taken proactive steps to streamline procedures for approvals, make the application process easier, engage with patient populations and give more medications “breakthrough therapy” designation status.
The past year brought 1,027 generic approvals, 46 novel drugs approved by CDER either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs), as well as 34 new biologics approved by CBER.
Trump’s reference to terminally ill patients indicates his endorsement of Congress’s efforts to pass a bill allowing access to experimental treatments for patients with terminal conditions.
While Trump has been contending that too many FDA rules in general pose unnecessary hurdles to drug approval, he has spoken very little about “right-to-try” legislation, other than to give his okay last February, following Vice President Pence’s endorsement. The legislation was passed by the Senate last fall, but has been stalled in the House.
The FDA has a “compassionate use” program available for people with terminal illnesses and Agency data claims that almost all terminal patients who seek access to drugs receive them. Despite this, backers of the proposed law contend that red tape at the FDA is still getting in the way of compassionate access to new drugs.
The proposed law, if it passed, will be in line with Trump’s urging to dispense with FDA rules that he says are stunting innovation.
Trump’s SOTU comments on the opioid crisis:
“These reforms [editor’s note: this was immediately following Trump outlining his approach to immigration reform] will also support our response to the terrible crisis of opioid and drug addiction.
In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour. We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge.
My Administration is committed to fighting the drug epidemic and helping get treatment for those in need. The struggle will be long and difficult -- but, as Americans always do, we will prevail.
As we have seen tonight, the most difficult challenges bring out the best in America.”
Trump’s comments suggest that he intends to address the opioid crisis through immigration reform and stronger drug enforcement. They also seemingly reflect a shifting emphasis away from blame – whereas previous media focus was on blaming pharma for pushing dangerous opioids without clearly stating addiction risks and doctors for overprescribing them – Trump is changing the dialogue, but still without much detail.
Last October, Trump directed the Department of Health and Human Services to declare the opioid crisis a public health emergency. This came two months after his opioid commission recommended he declare a full-on national emergency. The difference is that Trump’s directive does not, on its own, release any additional funds to deal with the drug crisis.
In addition, Trump has previously said his plan – which remains unclear – will involve stronger efforts to block shipments of fentanyl, a cheap and extremely potent synthetic opioid made in China, into the United States.
While it seems as though the pharmaceutical industry walked away from the address with its reputation largely unscathed, the continued lack of details surrounding the Trump administration's plans, such as drug pricing and opioid crisis initiatives, leave the door open to uncertainty.
CNN has the full transcript of the State of the Union address here