[schoonder]

It appears that FDA rules and regulations haven’t kept pace with and thus failed to account for significant changes in how medical scientists today attempt to develop subsets of new drugs that in large part are based on structural composition and specific characteristics of disease, i.e. targeting and killing off just the diseased components without adversely affecting healthy cells.

For Genentech to have included evaluations in their trial of how other treatment regimens, ineffective and no longer frequently prescribed for HER2+ patients would have fared versus T-DM1 3rd level MBC doesn’t only make any sense, but more so it becomes mind-boggling that FDA used this as excuse to delay this, for many an effective and safe drug, from becoming available to very ill people for at least two additional years. A ruling for patients that have depleted their available options becomes a death sentence. And yes, we are so aware that FDA for critical drugs can overrule the need to issue an RTF even if warranted.

Targeted medicine appears to be a much improved method to treat the disease, more efficacious and so much less debilitating to recipient that government needs to assure that vehicle (new rules and regulations) is in place to expedite these new type of drugs to market place. Streamline this process and strike requirements that trials of targeted drugs are required to conduct comparison tests against gamut of all previously approved medication ( old methodology) for given condition.