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Latest From Legislation
A French pilot project testing out the future EU clinical trial authorization procedures has borne fruit after the first two years, but the regulator wants many more sponsors to use the pilot so that the country is ready for the new rules in 2019.
Insurance practices are a big driver of drug pricing problems, according to Azar, a former Lilly exec who spent six years at HHS under George W. Bush, providing him valuable experience in department operations.
Top Republicans on FDA authorizing committees worry that undermining agency's sole authority to approve drugs and devices would bring more harm than good.
House IP Subcommittee Chair Issa suggests legislation may address sovereign immunity and ways to make inter partes review process more palatable to patent owners.
QuintilesIMS Institute study funded by the National Organization for Rare Disorders concludes orphan drugs accounted for only 7.9% of US total drug spending in 2016, bolstering advocacy group's view that rare disease treatments are not responsible for rising healthcare costs. US FDA analysis finds most orphan drugs do not expand their labeled indications into non-rare disease settings.
PhRMA is stepping up its advocacy for 340B reform, noting recent reduction in Medicare payments for 340B is encouraging in that it indicates Administration may be open to further change.
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