A bill to accelerate the discovery and development of new medical treatments was approved by a large majority in the House of Representatives of the States STATES today. The law, called Act 21st century Cures, has changed slightly from the version that won the unanimous support of the Energy and Commerce Committee of the House in May. And although it continues to enjoy the support of hundreds of industry, research and patient organizations, some scientists and advocates wonder if the effort to accelerate cures for patients could inadvertently compromise their safety.
The bill provides new funding for the National Institutes of Health (NIH) through a temporary "innovation fund" which would give the agency an additional $ 8.75 billion over 5 years; 500 million $ per year would finance specific projects in the 27 NIH institutes, including research on biomarkers and precision medicine remaining money would be to support young scientists. high risk, high reward research ; the intramural research;. and other areas the fund lost more than $ 1 billion from its previous authorization of $ 10 billion as sponsors struggle to pay for it in the midst of severe budget restrictions But lawmakers. Republicans have failed to adopt an amendment that would have made the discretionary-fund subject to the annual process of budget appropriations and therefore budget caps rather than mandatory.
project legislation also would authorize $ 550 million for the Food and Drug administration (FDA) and give the agency a host of new responsibilities. These include a new priority review process for some antibiotics, a process of accelerated approval for medical devices, and the creation of new guidance documents to counsel drug developers.
Several provisions are intended to smooth the way for approval of a large -priority treatments. It could allow the FDA to approve certain medical devices based on case studies and medical reports rather than data from larger clinical trials. In another, the agency could approve the drug to treat infections, threatening rare on the basis of smaller clinical trials. This could make the process easier for drug manufacturers who are struggling to recruit enough patients. "I think it's pretty broad understanding that this is necessary," says Amanda Jezek, vice president of public policy at the Infectious Diseases Society of America in Washington, DC "This would open the way for studies that were all just not able to do before. "
But some are concerned about the practical consequences of the fastest approval." For us, there are certainly concerns about ... the misperception that you might be able to speed innovation by lowering standards of safety and efficiency, and we think it would be a terrible mistake, "said former FDA Commissioner Margaret Hamburg at the National Press Club event just prior to resign in April.
in a perspective published in the New England Journal of Medicine last month, drug epidemiologist Jerry Avorn and expert in public health policy Aaron Harvard University Kesselheim landscaped concerns more detailed. they say that new provisions for appliances could lower safety standards, and they suggest that the accelerated antibiotics could pose a risk for patients who do not fit the limited pool of profile of patients on which they were tested. They also criticized a provision that would increase Medicare reimbursements to hospitals that use newer and more expensive antibiotics for serious infections. This move is intended to create an incentive for more profit for developers, but some argue that it could increase the use of hospital drugs and encourage greater bacterial resistance
Some policymakers apparently share this concern. An amendment adopted with the bill directs the Centers for Disease Control and Prevention study whether this incentive could actually contribute to the problem of resistance. The updated version of the bill will now go to the Senate, which has not yet issued its own bill on biomedical innovation.
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