In a historic first for the Association for Accessible Medicines annual meeting, Health and Human Services Secretary, Alex Azar, took the stage. “Thank you for showing us what is possible, thank you for proving the doubters wrong,” Azar said to the crowded room of generic drug manufacturers and advocates.
Getting a thank you from the one of the country’s biggest names in health and medicine is no small feat, and will likely continue to be a big win for the generics industry.
“Join us as we bring your successes to the rest of the heathcare system,” Azar said.
Despite having made a solid advocate in government through Azar, one of the biggest obstacles generic drugs continue to face has to do with political perception and misinformation.
“We’ve become the target of extreme political rhetoric. I never imagined that generics would be the target of policymakers,” Rob Stewart, CEO, Amneal Pharmaceuticals and incoming AAM chair, said, noting how drug pricing has become the No. 1 domestic policy issue for voters.
“We’ve entered a political environment where no price increase, brand or generic, is considered acceptable,” said Chip Davis, AAM President. And yet, voters and policymakers remain confused about the difference between generics and brand.
Many of the speakers at AAM Access! pushed generic drugmakers to provide clarification and transparency. They stressed the importance of investment and engagement with lawmakers, as well as the value proposition of investing in trade associations — aside from money, time is a valuable investment.
“Invest the time to tell your story to policymakers,” implored Davis during his opening address.
GRAB A SEAT AT THE TABLE
One of the biggest weapons generic drugmakers have on their side is real-world data — as the value proposition of generic drugs is undeniable. Generics save patients hundreds of billions of dollars annually, and almost two trillion dollars over the last decade.
But drugmakers need to be willing to share their stories.
“If you are absent or unwilling to share, then there is only one side represented in the debate,” said Davis.
During his colorful discussion (joined by his wife, Mary Matalin), James Carville echoed the importance of presenting data-backed solutions: “When you make your case, be relentlessly nice and relentlessly determined, and present a real solution.”
BIOSIMS JOIN THE PARTY
Biosimilars were top of mind at AAM Access! this year. The nascent U.S. biosimilars market is now facing many of the same obstacles that generics have been up against for years, including anti-competitive tactics employed by brand manufacturers to thwart biosimilar competition.
While some are quick to blame the U.S. Food and Drug Administration, saying it is lagging behind its European counterpart in approving biosimilar medicines, conference presenters thought otherwise.
“We don’t have a regulatory problem, we have a commercialization problem,” said Doug Long, vice president of industry relations, IQVIA, pointing out that while there are 17 biosimilars approved in the U.S., only five have launched commercially.
Carol Lynch, Sandoz U.S. president and head of North America, detailed biosimilar successes globally as well as the challenges currently facing the industry, also pointing out that “if all approvals of biosimilars had entered the market in a timely manner, American could have saved $4.5 billion.”
“This administration is not going to shrink from the challenges of the complex biosimilar market,” promised Azar. “Those looking to block biosimilars are on the wrong side of history."