President Donald Trump largely dodged talking about the Affordable Care Act during the State of the Union on Tuesday evening, but he did touch on a handful of healthcare items.
Lowering drug prices, pledging support for "Right to Try," speaking on the human cost of the opioid crisis, and claiming victory for repealing the individual mandate penalty were among the health-related pieces given national attention during the high-profile speech.
Critics and analysts note that many of the ideas put forward by Trump have little chance of being enacted or lack enough funding to be effective. Jefferies analysts projected a net neutral impact on drug pricing, and Cowen Washington Research Group's Rick Weissenstein recently noted that "rhetoric not withstanding we continue to believe there will not be any systemic effort to curb drug pricing in 2018."
Lowering 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," Trump said in prepared remarks.
But the comments are far tamer than when Trump said pharmaceutical companies "are getting away with murder," and suggested that the federal government negotiate drug prices for Medicare. Trump did not appear to be putting any specific policy proposals forward that would curb drug prices further.
He did commend his Food and Drug Administration for approving the most generic drugs in its history in 2017, an action Commissioner Scott Gottlieb and HHS Secretary Alex Azar have said would help increase competition and lower prices. Alexander Gaffney, senior manager at the PwC Health Research Institute, noted the trends started much earlier.
Yes, super important. Trend started under 2012 passage of FDA Safety and Innovation Act. Contained lots of new money for FDA to hire reviewers. Relevant parts of law (called Generic Drug User Fee Act) renewed in 2017 (FDA Reauthorization Act). https://t.co/BXLxKUWDaM— Alexander Gaffney (@AlecGaffney) January 31, 2018
One potential policy that could see movement is the CREATES Act. That proposal aims to stop brand drug companies from using distribution control to stop generic competition in the marketplace, and may be included as a payfor in an upcoming bill, according to Weissenstein. The Congressional Budget Office has said the measure would save $2 billion over 10 years, and it has seen some bipartisan support.
Right to Try
"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,'" Trump said.
The idea, dubbed Right to Try, has been pushed nationwide by the libertarian Goldwater Institute, with 38 states having passed laws. A version of the bill, which passed the Senate last year by unanimous consent, would allow terminally ill patients to request access to experimental drugs that have passed Phase 1 trials.
But critics say that the bill only gives false hope to patients, and could actually be harmful. Experts argue that the FDA has taken strides to improve its existing compassionate use program, and note that 99% of all expanded access requests are responded to within days.
"We do not need to undermine a working program that benefits patients by creating a deeply flawed alternative program that will only lead to further confusion and strip patients of crucial protections they currently have," Alison Bateman-House, assistant professor at New York University, testified before the House Energy & Commerce Health Subcommittee last October.
Tackling the opioid crisis
"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," Trump said.
Then-HHS Acting Secretary Eric Hargan recently renewed the administration's determination that a Public Health Emergency exists "as a result of the consequences of the opioid crisis."
But the determination, first declared last October, does not add the funding critics and lawmakers say is necessary to stem the tide of the epidemic.
Striking the ACA's individual mandate penalty
"We eliminated an especially cruel tax that fell mostly on Americans making less than $50,000 a year — forcing them to pay tremendous penalties simply because they could not afford government-ordered health plans. We repealed the core of disastrous Obamacare — the individual mandate is now gone," Trump said.
The GOP tax bill, signed into law in late December, nixed the individual mandate, considered a cornerstone of the ACA. Hospitals and insurers had strongly voiced opposition to striking the mandate, which was projected to leave 14 million individuals without coverage by 2026, with premium increases of 20%, according to the CBO.