If it feels like we’ve been talking about potential drug pricing regulation for years, well… that’s correct. This year was no exception. Take a look back at drug pricing news and some of the biggest health policy developments of the year.
Many drug price policies floundered in 2019. The rule that would require drugmakers to include the list price in TV ads is the best example. It was proposed early in the year, spurring some pharma companies like Johnson & Johnson and Eli Lilly to go ahead and include prices in their ads.
But once the rule was finalized in May, the pharma industry fought back, filing a lawsuit to delay or overturn the rule. In the end, the industry got its wish. One day before the rule was to take effect, a federal judge overturned it, saying that the Department of Health and Human Services overstepped its authority.
The idea isn’t dead yet. Senators reintroduced the TV list price disclosure rule in a bill in November, though it has not yet come to a vote.
On other drug price fronts, early in 2019, seven pharma executives appeared before Congress to discuss rising drug prices. The executives proposed solutions like increasing competition from biosimilars and generics and ending rebates to pharmacy benefit managers, while ducking questions about pharma advertising spend.
Not many drug price policies actually became law in 2019. The most promising and sweeping proposals, like the package from the Senate Finance Committee and House Speaker Nancy Pelosi’s drug price bill, are currently moving their way through the House and Senate.
Two major lawsuits seeking to hold pharma, drug distributors and pharmacies responsible for the opioid epidemic grabbed national attention this year.
The first, a lawsuit in Oklahoma, actually went to trial. Most of the defendants named in the suit settled, but Johnson & Johnson was the lone holdout when the trial began in May. After an eight week trial, the judge found J&J responsible for the state’s opioid epidemic, ordering it to pay $572 million, an amount that has since been reduced. Naturally, J&J has appealed that decision.
The second lawsuit, a federal case in Ohio that was being treated as a bellwether for more than 2,000 similar federal lawsuits, never made it to trial. After a series of settlements, bankruptcy filings and novel agreements between pharma companies, the trial was ultimately delayed.
This was the year phrases like “mystery illness” and “Dank Vapes” appeared in actual news stories.
The e-cigarette issue took on a new life once people started getting sick from vaping. Officials first noticed a trend of lung illnesses tied to vaping during the summer. As deaths steadily increased, health officials launched an investigation and states began implementing bans on some vaping products.
The issue peaked when President Trump got involved in September. He proposed a national ban on flavored e-cigarettes, which the administration hoped would address both the vaping lung illness and teen use of e-cigarettes. Trump later walked back on the proposed ban.
Meanwhile, the number of teens who vaped continued to rise, an issue the Food and Drug Administration has been grappling with for several years with public health campaigns like The Real Cost.
Juul has taken most of the heat for teen vaping in 2019. This year saw Juul executives appear before Congress to answer questions about its marketing tactics, the company pulling all flavored products from the market and several state lawsuits claiming Juul’s marketing caused a public health crisis.
The FDA spent most of 2019 headed up by interim leader Ned Sharpless, who mostly followed the lead of his predecessor. Dr. Scott Gottlieb stepped down from the role in April, leaving several issues he made hallmarks of his tenure unfinished, like e-cigarettes, CBD and streamlined drug approval.
This month, the Senate confirmed a new commissioner, Stephen Hahn. Little is known about Hahn’s views on these ongoing issues as he takes up the job.