Bipartisan antibiotics bill faces crucial extension

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A health care bill is facing criticism from some experts who say it could result in huge spending on the development of new antibiotics that may not improve patient outcomes in the long run term.

The bipartisan legislation, with its $11 billion price tag, aims to establish a subscription model in which antibiotic developers are paid up front for the use of their drug, which could spur a wave of new drugs on the market. To qualify, a new antibiotic must be checked against certain criteria in the bill – but doctors and experts are concerned about its effectiveness in practice.

Lawmakers backing the measure say such a model would spur 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 currently available drugs. The Centers for Disease Control and Prevention reports that 35,000 people in the United States die each year from such infections.

But some infectious disease experts have said the bill does not explicitly outline some trial-related conditions that improve patient outcomes. This includes conducting trials with patients resistant to the current generation of antibiotics.

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

One of the biggest hurdles to passing the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act is the price, according to an aide to Sen. Michael Bennet (D-Colo.), one of four sponsors of the legislation, which said the leadership is still unconvinced 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 an equal number of Republicans and Democrats, also faces additional challenges due to its extensive committee skills, according to Rep. Mike Doyle (D- Pa.).

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

“We are confident that if we can put all of these pieces together we can do it, but we still have some things to work out, some concerns that we have in the energy and commerce committee 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, Justice 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 supports the PASTEUR law, though an administration official did not return a request for comment for this story.

One of the measure’s most vocal supporters is The Pew Charitable Trusts, which sees antimicrobial resistance and overprescription of antibiotics as a growing issue in light of the COVID-19 pandemic. The Pew Charitable Trusts found that 52 percent of people admitted to hospital with COVID-19 were prescribed at least one antibiotic.

“One of the main reasons why we are strong supporters of PASTEUR is not only that it deals with the part of the economic incentives and the side of drug development that is necessary to develop new antibiotics, but it answers also to the need for an equal arm of antibiotic stewardship so that we can ensure that these new antibiotics, when they become available on the market, will be used appropriately,” said David Hyun, director of the resistance project. antibiotics at The Pew Charitable Trusts.

The Infectious Diseases Society of America (IDSA) is also pushing for the PASTEUR law. The bill would provide doctors with the antibiotics 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 new antibiotics reviewed, every label approved by the Food and Drug Administration for these antibiotics contained at least one group of patients who were not allowed to participate in the trials. This raised concerns that antibiotics whose trials excluded certain groups – such as people resistant to current antibiotics – could be approved for the subscription contract under the bill.

Miller said the bill wouldn’t necessarily lead to better treatment by giving patients and doctors more drugs to choose from.

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

Another issue is the idea of ​​bringing more drugs to market that aren’t significantly different from current drugs, which poses a problem due to mutations in bacteria that could be resistant to new drugs, said Diana Zuckerman, president from the National Center for Health. Research, a health policy think tank.

“Prescribing the new drug will increase the likelihood that there will be resistant bacteria, because the new drug is so similar to other drugs on the market.” says Zuckerman.

The PASTEUR law does not specify what characteristics or how much an antibiotic must meet, raising concerns among doctors and antibiotic experts about the effectiveness of the legislation if it becomes law.

It also does not explicitly describe trials that infectious disease experts say should include patients resistant to the current generation of antibiotics who should be compared against current and new drugs.

The ultimate goal of the PASTEUR law, 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 only awarding investment contracts for drugs that achieve a high bar demonstrating a number of new characteristics – such as unmet clinical need, targeting resistant infections and targeting organs where infections are usually difficult to treat,” Ferguson said in a statement to The Hill.

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

“Everyone, I think, understands that for all intents and purposes, time is running out and we don’t have many legislative days left to get things done. We hope we can move it,” Doyle said.

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