Antibiotic-resistant bug battle wins bipartisan support in Congress

A bill surfaced in the final days of the current Congress with bipartisan support to ease regulatory requirements to get drugs that treat antibiotic-resistant bacteria approved, and it is expected to also be considered by the new Congress in January.

That expectation of it resurfacing next year “demonstrates their commitment to this issue,” said Amanda Jezek, vice president of public policy and government relations at the Infectious Diseases Society of America.

The legislation, introduced Wednesday by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah), calls for a new drug approval pathway that would streamline how these drugs are brought to market, in part by narrowing the patient population used in clinical trials. That would lower costs for manufacturers, making the trials more financially feasible, advocacy groups say.

The legislation would give the Food and Drug Administration the authority to use this pathway to approve new antibiotics, which is expected to speed up the process of getting drugs on the market. Another bill, similar to the one introduced this week, is in the House.

“We feel there's really strong momentum” in support of improving the way that antibiotics are approved, Jezek said.

More attention in recent years has focused on superbugs, such as carbapenem-resistant Enterobacteriaceae and bacteria that are resistant to existing antibiotics and whether the market has adequate incentives for drugmakers to pursue development of antibiotics.

Two years ago, Congress passed legislation that provides priority review, fast-track eligibility and extended exclusivity periods to pharmaceutical manufacturers developing drugs that are designated “qualified infectious-disease products.”

And earlier this year. President Barack Obama created a task force to develop an action plan that helps address antibiotic-resistant bacteria.

“Both sides of the aisle seem to recognize the importance of the resistance issue,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts.

By 2050, so-called superbugs could kill an additional 10 million people annually and so create a loss in global economic output that could total up to $100 trillion if new treatments aren't developed, according to a British government-commissioned report released Wednesday.

The growing interest in developing new antibiotics is also being reflected in the market. Earlier this week Merck, one of the world's largest pharmaceutical companies, said it would spend $9.5 billion to buy Cubist Pharmaceuticals, which makes antibiotics, several of which treat superbugs.

In a report published Thursday, Moody's Investors Service noted that the Cubist deal will expand Merck's antibiotics portfolio at a time “when the sector is becoming increasingly competitive.”

Follow Jaimy Lee on Twitter: @MHjlee