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User fee bill needs to address pharma’s role in the climate crisis – Boston, Massachusetts

Boston, Massachusetts 2022-06-08 04:45:46 –

A■ Congress is working on re-approval 7th time The Pharmaceutical User Pricing Act overlooks the climate crisis, which should be part of virtually every law affecting the industry these days.

The Prescription drug usage fee methodFounded in 1992, it collects user fees from the industry, primarily to the Food and Drug Administration, to review and approve patents and generics, biosimilars, medical devices, and related FDA performance goals. You are authorized to do so. This update reapproves the law from fiscal year 2023 to fiscal year 2027.

On May 18, the House Energy and Commerce Committee passed a user rate bill. HR 7667.. The day before, the Senate Committee on Health, Education, Labor and Pensions (HELP) announced a bill. Senator Patty Murray (D-Wash.), The chairman of the committee, wants to move immediately. That billVersion Congress will finally approve from the Commission earlier this month.

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The bill also serves as an important impetus for everything else, as the reapproval of FDA user fees must pass the bill. Improvement of regulatory policy This enables the FDA to respond to scientific knowledge and enable the FDA to fulfill its responsibilities for public health, patient and consumer health, and well-being.

Notably, both bills lack all efforts to mitigate the massive carbon pollution emitted by the pharmaceutical industry, the extension of this horrific exclusion in 2017, and the renewal of previous user fees. Approval, and FDA-compliant drug approval in related 21st century therapeutic legislation. The Biden administration was unable to curb carbon emissions in the healthcare industry.This is the president Greater climate ambitions I’m dying more and more. In addition, pharmaceutical companies’ carbon emissions will self-destruct in the long run as they operate the industry beyond the limits or limits of both environmental and economic sustainability. In 2019, STAT recognized industry efforts The guard itself For increasingly dire climate-related disasters, partly caused by pharmaceutical companies.

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Congress will not be able to pretend that the FDA is fulfilling its public health and patient health responsibilities if the industry simply allows it to continue to pretend to be offered. “A life-saving prescription drug.”

The global pharmaceutical industry emits large amounts of deadly carbon and carbon equivalent pollutants. How deadly is it?Almost in the United States alone 60% Excessive deaths in the United States each year are due to pollution caused by the burning of fossil fuels, and the healthcare industry’s own emissions are 98,000 Each year, the death toll in the United States is disproportionately experienced by Medicare and Medicaid beneficiaries (taxpayers support medical care) and the colored community. At least 12% of these come from the pharmaceutical industry. In 2015, the pharmaceutical industry’s emissions reached 52 million metric tons of CO.2Represents about 20% Of total medical emissions. From a point of view, the pharmaceutical market was 28% smaller and 55% more polluted per $ 1 million in revenue, but this was 13% more emissions than the automotive industry.

The energy intensity of the pharmaceutical industry also varies greatly from company to company, 5 times or moreEven if a company sells a similar product line and generates similar revenue.

In addition to their carbon emissions, pharmaceutical companies are also responsible for them Direct release of pharmaceutical residues It invades an environment that can exceed toxic concentrations (not covered by the User Charges Act).

Sadly, the failure of user tariffs to address pharmaceutical companies’ carbon and other emissions seems to be consistent with HELP’s silence on the contribution of the pharmaceutical industry to the climate crisis. In early March, Murray Pandemic Prevention LawShe said it was aimed at “improving national readiness for future public health emergencies.” But the law also ignores the climate crisis, despite the fact that hundreds of Malay members were killed in 1,000 years last year. heat wave The warming of the Anthropocene has made it 150 times more likely.Her indifference reminds me of George Orwell Characterization The party members of his novel “1984” said, “They never fully grasped the enormousness of what they were asked to do, and they weren’t interested enough to notice public events, so they were the most in reality. I was able to get them to accept a serious breach. ”What was happening? “

Absent Parliament and / or Department of Health and Human Services Secretary Xavier Becerra, like Walt Vernon and I, abuses his regulators to request Medicare-approved providers to report and reduce emissions. To do. Claim in STAT Last June, a small number of sustainability leaders in the pharmaceutical industry wanted clarification of regulations, and the FDA needs to act independently unless there is a compelling reason to do so.

As for early adopters, 10 pharmaceutical companies, including Novartis, are making good progress in the fall of 2021. Carbon neutral Established for its own business by 2025 Give energy, Collaboration to increase access to green energy resources.Among other leaders, Amgen, J & J, Roche Reduce carbon emissions Over the last four years, it has increased by more than 18% and revenues have increased by up to 27%. This further demonstrates the fact that renewable energy is a business opportunity, not a threat.

At the very least, the User Fees Act requires a public report.Doctor Emily Senay and her colleague in March New England Journal of MedicineThe healthcare industry has much to learn from Coca-Cola and others by systematically measuring, managing, mitigating, and regularly reporting publicly disclosed and validated emission data.More aggressively, the FDA needs to take Other steps Related to related proven efficiency Continuous manufacturingg.Agencies also need to pursue 2021 Recommendations Dr. Georges C. Benjamin and Howard Frumkin were approved by 75 health agencies. These include encouraging emission reductions with regulatory approval.

This work fits perfectly under the current Critical Path Initiative of the FDA’s Center for Drug Evaluation and Research (CDER). As CDER states“Stimulate and support national efforts to modernize scientific processes.” If the FDA runs out of regulatory ideas, it will overcome the ignorance associated with American exceptionalism, among other things. european unionAnd the United Kingdom United Kingdom National Health Service When Royal Pharmaceutical SocietyAmong other overseas organizations.

The planet will probably warm up on average 1.5 degrees Celsius Will not be able to meet with it within the next few years Central purpose Part of the 2015 Paris Agreement, at least 2.7 C..Upwardly Responsible U.S. 40% Current and past carbon emissions 101st place Because of its climate policy, it is chasing all but one western democracy. If left untouched, the impact of Anthropocene warming on human health and the biosphere will be increasingly dire. As the United Nations ” Climate report It was concluded in February, “Further delays … will miss the short and rapid closing opportunity to ensure a livable and sustainable future for all.”

There are no patented or generic drugs, biopharmacy, or medical devices that can solve this. Murray and Congress must act and act decisively to play their role in leading the pharmaceutical industry into the fight against the climate crisis.

David Introcaso is a Washington, DC-based healthcare research and policy consultant whose work is increasingly focused on the climate crisis.



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