12:00 AM
Apr 28, 2003
 |  BioCentury  |  Regulation

BIO's biogeneric broadside

The Biotechnology Industry Organization has asked the FDA to abort any initiative that could lead to abbreviated mechanisms for approving biogenerics, issuing a strongly worded petition to the agency that BIO President Carl Feldbaum says is a plea for industry to be included in the decision-making process.

The generic drug industry views BIO's petition, however, as an effort to obstruct and delay the creation of laws and regulations that would subject biotech products to competition.

The biotech industry has been particularly concerned by reports about remarks made at conferences by Commissioner Mark McClellan and other FDA officials, which suggest the agency is well down the path of biogeneric policymaking.

A week before BIO submitted its Citizen Petition on Follow-on Therapeutics, Feldbaum sent a letter to McClellan, warning that "any hint of uncertainty or confusion in any FDA regulation" makes it more difficult for biotech companies to conduct research or raise capital.

"Our members are concerned when it looks as if FDA policies are changing unpredictably...

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