Generic Biologics Won't Get A Free Ride

Implications: Allowing "generic" versions of biotech drugs to market without full safety testing would endanger consumers

Analysis: At a time when Congress is rushing to increase (at least the perception of) drug safety by pressuring the FDA to slow down drug approvals, it is at the same time considering a move that would endanger consumers by allowing some drugs to market without adequate safety testing.

Congress is considering allowing fast-tracking the approval of "generic" or "Follow on biologics" --  biotech drugs that may in fact not be exactly the same as the original medicine.

The reason? Congress fails to understand that biotech drugs are --by their nature-- different from traditional pharmaceutical products.  While typical medicines are relatively easy to reproduce in the form of generics, biotech drugs require a much more complicated process. In fact, the trick in making  biotech drugs, is the process. And generics can't just copy that process the way thy can "copy" traditional medications.

While Congress is eager to offer ways to help consumers gain access to lower cost drugs (in the form of generics), they must consider the safety implications of fast-tracking follow-on biologics.  Have members of Congress forgotten their "safety at all costs" approach?   They ought to apply just a drop of their misplaced over-precaution where it belongs -- where it is needed-- and not allow follow-on biologics without proper safety testing.