Bipartisan bill on antibiotics faces crucial stretch

A health care bill is facing criticism from some experts who say it could lead to huge spending on new antibiotic drug development that may not improve patient outcomes in the long run.

The bipartisan legislation, with its $11 billion price tag, aims to establish a subscription model in which antibiotic developers are paid upfront for the use of their medicine, which could spur a flurry of new drugs to the market. To qualify, a new antibiotic must be checked against certain criteria in the bill — but physicians and experts worry how effective that could be in practice. 

Lawmakers who back the measure say such a model would encourage innovation in drug development to combat what they say is a looming health crisis caused by antimicrobial resistance, which occurs when infections can no longer be treated with the drugs currently in circulation. The Centers for Disease Control and Prevention reports that 35,000 people in the U.S. die from such infections annually

But some infectious disease experts said the bill does not explicitly outline certain conditions related to trials that improve patient outcomes. That includes running trials with patients who have resistance to the current generation of antibiotics. 

“It shouldn’t be so much about more drugs but better drugs. We want drugs to come out that dominate the current [antibiotics], and we are very concerned that we are not going to get that out of this,” said Mark E. Miller, the executive vice president for health care for the philanthropy-funded Arnold Ventures, which develops evidence-based policy solutions to improve health care.

One of the biggest obstacles to passing the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act is the price tag, according to an aide to Sen. Michael Bennet (D-Colo.), one of the legislation’s four sponsors, who said leadership isn’t yet convinced that much money needs to be allocated to address the issue at this time.

The House bill, which has 60 co-sponsors made up of equal numbers of Republicans and Democrats, also faces additional challenges due to its many committee jurisdictions, according to Rep. Mike Doyle (D-Pa.). 

Despite the uncertainty, Doyle, who introduced the legislation, anticipates the bill will move later this year, most likely attached to a larger legislative vehicle.

“We’re confident that if we can pull all these pieces together that we can do it, but we still have some things that need to be addressed, some concerns that we have right in the Energy and Commerce Committee in dealing with the multiple jurisdictions,” Doyle told The Hill. 

Other committees that have jurisdiction over the bill in the House include Ways and Means, Veterans’ Affairs, Armed Services, Judiciary and Homeland Security. 

The bill was first introduced in September 2020, before being reintroduced by Bennet, Doyle, Sen. Todd Young (R-Ind.), and Rep. Drew Ferguson (R-Ga.) in June 2021. 

Democratic members say the White House backs the PASTEUR Act, though an administration official did not return a request for comment for this article. 

One of the measure’s more vocal proponents is The Pew Charitable Trusts, which sees antimicrobial resistance and the over-prescription of antibiotics as an increasingly important issue in light of the COVID-19 pandemic. The Pew Charitable Trusts found that 52 percent of people admitted to the hospital with COVID-19 were prescribed at least one antibiotic.  

“One of the main reasons that we are strong supporters of PASTEUR is not only does it address the economic incentive portion and the drug development side that is needed to develop new antibiotics, but it also addresses the need for an equal arm of antibiotic stewardship so that we can make sure that these new antibiotics, when they do become available on the market, are used appropriately,” said David Hyun, director of the Antibiotic Resistance Project at The Pew Charitable Trusts.

The Infectious Diseases Society of America (IDSA) is also lobbying for the PASTEUR Act. The bill would provide physicians the antibiotics that they need to care for their patients, according to Amanda Jezek, senior vice president of public policy and government relations at IDSA.   

However, research from the Mayo Clinic found that of 21 novel antibiotics examined, every Food and Drug Administration-approved label for such antibiotics contained at least one group of patients who were restricted from enrolling in the trials. This has raised concerns that antibiotics whose trials excluded certain groups — such as individuals who are resistant to current antibiotics — could be approved for the subscription contract under the bill. 

Miller said the bill won’t necessarily lead to better treatment by offering patients and physicians more drugs to choose from.

“We’re going to spend this money, we’re going to get inferior drugs, and the doctors aren’t going to prescribe them then. If you’re going to spend this money, get dominant drugs,” Miller added. 

Another issue is the notion of bringing more drugs into the market that are not vastly different from the current drugs, which poses a problem due to mutations of bacteria that could be resistant to new drugs, said Diana Zuckerman, president of the National Center for Health Research, a health policy think tank.

“Prescribing the new drug will make it more likely that there will be resistant bacteria because the new drug is so similar to other drugs on the market.” Zuckerman said.  

The PASTEUR Act does not specify which or how many characteristics an antibiotic must meet, raising concerns from physicians and antibiotic experts about how effective the legislation would be if it became law.  

It also does not explicitly outline trials that infectious disease experts said should include patients who have resistance to the current generation of antibiotics that should be compared to current and new drugs.

The ultimate goal of the PASTEUR Act, according to lawmakers, is to prevent another global public health crisis such as the COVID-19 pandemic.

“The legislation would do this in part by awarding investment contracts for only those drugs that meet a high bar demonstrating a number of novel characteristics – such as unmet clinical need, targeting resistant-infections, and targeting organs where infections are usually hard to treat,” Ferguson said in a statement to The Hill. 

Doyle added that a team of representatives from all of the relevant federal agencies, doctors, patients and outside experts will be responsible for developing and implementing guidelines with regards to the type of characteristics that new drugs will be required to meet.

“Everyone, I think, understands that for all intents and purposes the clock is ticking and we don’t have that many legislative days left to get things done. We’re hoping to be able to move it,” Doyle said.