In the House of Representatives of the United States panel today released a long awaited proposal to accelerate development new medical treatments. The massive paper, 393 pages, called the Act 21st Century Cures, has been under development by Fred Upton (R-MI) and Diana DeGette (D-CO) of the Committee on Energy and Commerce House since last April . He was born of a series of hearings and roundtable discussions last year on ways to stimulate innovation in biomedical research and streamline clinical trials and drug approval process. The result is a long list of ideas summarized in this document.
The document is a "discussion paper" the committee said in a statement. Upton invited comments through Twitter handle # Cures2015. "Some things can be deposited, certain elements may be added, but everything is on the table as we hope to initiate a thoughtful discussion towards a more brilliant product," he said in a statement.
DeGette, in a statement, said she appreciated the effort of Upton "to share publicly as possible the legislative language on a number of proposals that could be included in a future bill. ... Although I do not endorse the draft document, I know that with continued commitment, we can achieve a bipartisan consensus to support research and biomedical remedies advance. "
many parts of the project are to convince developers of drugs to focus on diseases for which there are few treatments. a section, called the Act Dormant therapies, takes aim medicines for diseases complex, such as Alzheimer's disease, which are particularly long to develop and test. by setting a fixed period of patent exclusivity after such treatments gain approval (and not when the drug is first identified), the bill would give drug developers more time to recover costs and make profits. other provisions extend the exclusivity period for patents on medicines to treat rare diseases, new antibiotics, and for improving existing drugs such as a new formulation which reduces side effects.
The draft proposal also aims to speed clinical trials and integrate new types of data in the US assessment process Food and Drug Administration. The agency would be required to set standards for how it will evaluate "placeholders" for -measure biological response of a patient to a drug that may indicate the benefits faster than measures such as survival and disease progression. It should also be the agency to develop a new method for incorporating patient feedback in the evaluation of a new treatment.
The project also offers a 21 century Cures Consortium, involving federal agencies, pharmaceutical companies, patient groups and other stakeholders who work together on ways to get drugs to patients more quickly. National Institutes of Health (NIH) beneficiaries would be required to share data, and data from health care facilities would be made available for research.
Certain provisions to NIH, which funds most basic biomedical research in the nation, have been proposed by the agency. For example, the NIH drug development branch, the National Centre for the Advancement of Science Translational, would no longer be forbidden to fund clinical trials beyond the stage known as phase IIA name.
Other representative proposals Andy Harris (R-MD) may be more controversial. For example, the project calls for setting aside a part of the NIH Common Fund to finance the proposals of scientists early in their careers. Although this is a smaller version of a back plane Harris earlier that would have required NIH to lower the average age of a member for the first time, he could still draw concerns about such a setting fallow. Harris also wants NIH to develop a comprehensive strategic plan. This idea flopped when last attempted agency, there are more than 2 decades.
Other sections remain to be fulfilled, including one on "precision medicine," the subject of an initiative announced by President Barack Obama in his State of the Union address last week .
Biomedical research groups offer praise. the project "represents a promising opportunity," said Carrie Wolinetz, president of the United coordination group for medical research, in a statement. "Funding for medical research has stalled over the past decade. ... The initiative of the 21st century Cures will help revive its engine. "
" The initiative could be a game changer for the ecosystem of medical innovation, "said Mary Woolley, president and CEO of the advocacy group Research! America, a report. "Among the many provisions beneficial research! America fought for a measure to reduce the administrative burden on researchers, "she noted. (Research Universities have long complained about the regulatory burden.)
The approach is also attracting interest the Senate of the United States. a statement by senators Lamar Alexander (R-TN) and Patty Murray (D-WA), the top Democrat and Republican, respectively, the health Committee of the Senate, noted that one of the priorities of their committee is also "the modernization of the Food and drug administration, helping to get treatment and medication to patients as quickly and as safely as possible."
committee now plans to gather feedback on the project, with an eye to push the legislation before the end of this year.
* updated January 27 5:31 p.m. :. this article has been updated to clarify that the document does not constitute a formal legislative proposal
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