<\/p>\n
Even if the FDA were to provide some kind of assurance, it wouldn\u2019t necessarily protect biotech companies in the long term, cautions Chris Robertson, a specialist in health law at Boston University. The FDA\u2019s position could change with a new presidential administration, he says: \u201cI wouldn\u2019t bet on anything that the FDA is saying today being applicable when the rubber hits the road later.\u201d\u00a0<\/p>\n
Companies that want to stay on good terms with the FDA would be safest taking the expanded-access route, says Robertson. That\u2019s the pathway the FDA already uses for people who are seriously or terminally ill, have run out of options, and want to try experimental drugs that have not yet been through clinical trials. The FDA approves over 99% of these applications, says Harvard\u2019s Kesselheim.\u00a0<\/p>\n
\u201cThe FDA isn\u2019t a bottleneck but in fact exists to help ensure that expanded-access programs are aboveboard and that patients who receive [the drugs] are able to contribute knowledge about [them],\u201d says Kesselheim. He says he doesn\u2019t think that any \u201clegitimate manufacturer\u201d should fear having to go through the FDA\u2019s expanded-access process, which the agency says takes \u201cless than 45 minutes\u201d to fill out.<\/p>\n
There are some key differences between expanded access, which allows seriously ill people to apply for access to experimental drugs that might not have been through any human trials, and Montana\u2019s approach. In theory, a person doesn\u2019t need to be seriously ill to access experimental drugs in Montana.\u00a0<\/p>\n
\u201cIn Montana, patients may be eligible for preventive or earlier-stage interventions if they provide informed consent and meet the program\u2019s requirements, so the breadth of potential therapies and situations is much broader,\u201d says Kaeberlein, the Montana ETRB member, who is an affiliate professor at the University of Washington in Seattle.<\/p>\n<\/p><\/div>\n
#Montanas #plan #experimental #medical #hub #pushed<\/p>\n","protected":false},"excerpt":{"rendered":"
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