HHS nominee’s company ‘gamed’ drug patents

In his first appearance before members of Congress as nominee for HHS Secretary, Alex Azar promised to deliver a report on how the agency can limit “gaming” of patents and exclusivity by pharmaceutical companies. But when Azar was working at pharma giant Eli Lilly, the company took advantage of the very methods he’s pledging to fight.

According to POLITICO, Eli Lilly extended its patent on the very profitable erectile dysfunction drug Cialis for six months by testing its effectiveness for Duchenne muscular dystrophy, a rare pediatric muscle-wasting disease. The trial failed, but the patent extension is a valuable tactic Eli Lilly and pharma rivals use to extend exclusivity on money-making drugs like Cialis, which brings in an estimated $2 billion annually. At times, the company even openly highlighted the financial benefits of these dubious research projects.

“The key purpose of these studies is to do relevant clinical trials done in in the pediatric population. And the studies do not necessarily have to be positive,” Lilly’s then Research and Development Chief Jan Lundberg said at a healthcare conference in March 2016.

At the same time, Eli Lilly regularly raised the wholesale price of Cialis multiple times a year, far outpacing the rate of inflation and fought against proposed regulations that would have punished companies for those kinds of increases.

Azar “gamed the patent system to protect Eli Lilly’s taxpayer-funded profits under the guise of helping sick kids,” said Tyson Brody, research and investigations director of the left-leaning Democracy Forward.

Read more at the link below:

""
John Gregory, Senior Writer

John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.

Around the web

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Trimed Popup
Trimed Popup