BIO and Sen. Kay Hagan (D-NC) are working on draft legislation that would clear a shortcut through clinical trials straight through to the FDA for developers engaged in rare disease drug work, according to a report from Bloomberg.
Citing Senate aides involved in the legislative process, Bloomberg says BIO is angling to have the FDA's regulatory mandate tweaked to lay out the groundwork for marketing approval of a drug that meets an unmet medical need with just Phase II data. The agency has the authority to do just that, but rarely uses it. The new legislation would spell out the rules, mapping a clear path for developers who meet the criteria.
The FDA, of course, already offers orphan drug incentives, with developers able to get special tax breaks and a 7-year stretch on their market monopoly rights. The agency has also been discussing plans to speed up approvals for new drugs that promise exceptional results. In a certain sense, the recent accelerated approval for Roche and Plexxikon's melanoma drug vemurafenib illustrated the agency's willingness to step lively when it sees something particularly promising.
Nevertheless, a grumpy biotech industry has been complaining incessantly that regulators overall are far too slow to hit the green light on a drug. The regulatory hurdle has been cited repeatedly for being far too high for the venture groups that back drug developers. And new legislation that doesn't require extra federal dollars might be received warmly by lawmakers.
- here's the story from Bloomberg
FDA boasts of 35 drug approvals in past year amid criticisms
Roche wins early approval for blockbuster melanoma drug vemurafenib