Trump Targets Drug Prices, Right-to-Try in State of the Union

President Donald Trump returned to a popular campaign theme in Tuesday’s State of the Union address when he vowed to bring down the high cost of prescription drugs. But Trump’s only specific solution—calling on Congress to pass a right-to-try law—doesn’t address the broader problem affecting millions of Americans: the annual increases of necessary drugs for chronic conditions, such as insulin for diabetes or anti-inflammatory biologics for rheumatoid arthritis.

“There’s certainly been a gap between rhetoric and reality,” John Rother, president and CEO of the National Coalition on Health Care (NCHC), told The American Journal of Managed Care^® in an interview.

Previously, NCHC ran the Campaign for Sustainable Rx Pricing, which did extensive polling during the 2016 election cycle on Americans’ views on prescription drug pricing. Rother agreed with the overnight observation that the president highlighted the issue for a convenient reason: the president’s own poll numbers are not good, and polls still show Americans are frustrated with high drug prices. A poll taken last fall by the Harvard School of Public Health found that 40% of Americans want Congress to bring down prescription drug prices—a higher score than any other issue surveyed, according to POLITICO.

“One of my greatest priorities is to reduce the price of prescription drugs,” Trump said Tuesday night. “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.”

He called on Congress to pass so-called right-to-try legislation, which allows patients to bypass FDA’s Expanded Access program and go straight to the pharmaceutical companies to purchase investigational medications if they are facing a terminal disease. Several states have passed their own versions of right-to-try laws. Diana Zuckerman, president of the National Center for Health Research and a board member of the Reagan-Udall Foundation, told attendees at Patient-Centered Oncology Care® in November 2017 that the Right-to-Try bill that has passed the Senate has far fewer requirements than the FDA’s Expanded Access program; and there are concerns that patients taking these drugs will not track adverse effects, which could threaten the current system of drug development.

And while some patients with rare or terminal conditions without cures do face high costs, most of the prescription drug crisis is due to the avoidable practice of annual or semi-annual markups of existing drugs for chronic conditions. Rother said this problem affects many more patients and accounts for the vast majority of drug company profits.

“Pfizer raised the price of its entire product line twice last year, and compounded effect is quite dramatic” Rother said. “It’s not just 1 or 2 drugs. It’s an industry wide practice that does need to be challenged.”

The Pharmaceutical Research and Manufacturers of America, or PhRMA, has launched a patient-focused education initiative, “Let’s Talk About Cost,” that talks about the roles of insurers and “middlemen,” or pharmacy benefit managers. Indeed, the major public-facing explosions over drug prices—such as the rising price of EpiPens—occurred when changing benefit designs forced higher out-of-pocket costs as more consumers had to reach their high deductibles to gain access to essential drugs.

Late Wednesday, PhRMA released a statement saying it was working with Trump and Congress on "market-based solutions" to address healthcare costs:

“America’s health care system is complex and we need a holistic approach to addressing patient affordability challenges. Spending on retail medicines grew just 1.3% in 2016 as a result of robust negotiation and competition in the marketplace. At the same time, a record number of new medicines were approved, including therapies with the potential to cure childhood blindness and transform how we treat various cancers, enabling us to improve patient care and avoid expensive hospital services. As we consider reforms, it is important to focus on costs across our complex health care system, including those being retained by the biopharmaceutical supply chain and the impact of hospital mark ups on medicine prices.

“We support policies to modernize the drug discovery and development process and enhance competition and lower out-of-pocket costs for patients. Market-based reforms like these can help make medicines more affordable and accessible for patients and reward the risk-taking required to bring new treatments and cures to patients.”

During his speech, Trump mentioned FDA's breakneck pace for approvals in 2017, although Congress' applause was muted. FDA approved 46 new drugs, the most since 1996, but the prices for many made headlines: including the blindness therapy, Luxturna, priced at $850,000, and CAR T-cell therapies for blood cancers that cost $475,000 per cycle. On Monday, when he attended the swearing in of his new HHS Secretary, former Eli Lilly president Alex Azar, Trump said he was picking someone who knew the industry and the issues and would be able to do something about these high costs. During Azar's confirmation hearing, Democrats expressed their doubts.

Rother doesn’t see much progress from a White House working group but he did have praise for FDA Commissioner Scott Gottlieb, MD, who has won plaudits for his work to speed approvals of generic drugs and biosimilars and “taken some steps to limit industry game playing,” Rother said. Going in, Gottlieb was criticized for his ties to the industry, but he vowed to use that knowledge to make changes. The problem is that FDA is constrained from directly regulating prices.

On the campaign trail, Trump called for bold steps like letting Medicare negotiate drug prices and importing cheaper drugs from other countries. Asked whether Trump realizes that it is Congress, not Azar or his White House, that would have to approve such steps, Rother said, “To give him the benefit of the doubt, I think he has no idea … This administration has not put any proposal in front of the Congress, and their actions to date haven’t indicated that one is being developed.”