'March-in' battles heat up as nonprofits petition HHS on 6 drugs as earlier petition awaits decision
Eight nonprofits including Public Citizen and PrEP4All are petitioning HHS Secretary Xavier Becerra to use controversial “march-in” rights to lower the prices of 6 drugs.
The idea behind the letter is centered on the Bayh-Dole Act, which allows federal agencies to march-in on a federally-funded invention when a rights holder fails to achieve “practical application” of the invention, meaning that the rights holder fails to make the benefits of the invention “available to the public on reasonable terms.”
Such a move in the realm of drug prices has never occurred before, but several high-profile Democrats in recent months have signaled that it’s well within HHS’ legal bounds to get creative in finding new ways to bring down drug prices. Republicans and pharma have derided the idea as more of a cheap trick (NIH has never agreed to use march-in) that would discourage R&D, and particularly R&D on government-funded products.
This latest petition released Thursday targets price reductions for Pfizer’s prostate cancer drug Xtandi ($129,000 per year) and its Covid-19 drug Paxlovid ($530 per 5-day course) which has been in short supply, Gilead’s HIV drug Descovy ($24,000 per year) and its hepatitis C drug Epclusa ($24,000 list price even with an authorized generic), as well as inhalers and insulin, which are notoriously expensive and difficult to make generically.
The petition builds on an earlier petition from several diagnosed with prostate cancer that is seeking to march-in to lower Xtandi’s price specifically. NIH said yesterday that it’s still reviewing that petition, although it previously said it would complete its review by last month.
“We are currently reviewing the information submitted in the 2021 petition to determine whether the initiation of the march-in procedures outlined in 37 CFR 401.6 may be warranted,” acting NIH director Lawrence Tabak said in a letter dated March 24 to Rep. Peter DeFazio (D-OR).
Early last month, DeFazio and Rep. Lloyd Doggett (D-TX) sent a letter to Becerra urging him to use march-in to lower these prescription drug costs. And this week’s petitioners noted that the federal government’s use of the law allowing march-in occurred repeatedly in the 1960s to buy low-cost generic drugs.
But industry and others continue to beat the drum over the wider ramifications of such a move.
A little more than a week ago, nearly 100 academics, life science organizations, lawyers and others sent a letter to Becerra calling on him to reject the petition, explaining that march-in
was never intended as a means for the government to impose arbitrary price controls on resulting products, as the NIH has concluded time and again. As then NIH Director Elias Zerhouni noted in 2004 while rejecting the first march in petition seeking to impose price controls on a successfully commercialized product: ‘… the extraordinary remedy of march-in rights is not anappropriate means of controlling prices.’ That was correct then and remains so today.