Replies to post #52647 on Biotech Values

[Biopharm investor]

Dew, re: user fees

I don't think the backlog of submissions is as big of an issue to the major generic firms as the press would indicate. The Agency has generally been relatively good about acting timely on submissions that would open a market (i.e., PIV FTF's). Where they have been slow to act is on submissions like the 18th ANDA for atenolol, where the market is already saturated and the price is already deeply discounted. The major generic firms really have little or no interest in funding additional staff to act in a more timely fashion on these kind of submissions.

I think what the major firms want is other trade offs (e.g., curbs on the abuses of Citizen's Petitions that delay opening a market).

Regards