US House votes on FDA amendments: biogenerics reform may fall

The Consumers Union has welcomed the overwhelming US House of Representatives approval of what it describes as "the first major prescription drug safety improvements in nearly half a century and work on sending a strong bill to the President to help prevent future Vioxx-type disasters." However, a major stumbling block in the final passage of the legislation is the failure of the House to consider the issue of generic versions of biotechnology drugs, which the Senate addressed recently (Marketletter July 2).

The House voted 403-16 on July 11 for the Food and Drug Administration Amendments Act of 2007 (HR 2900). The Senate had already passed its version of the bill (S 1082) on an earlier date. Both measures include nearly $400.0 million in industry user fees to help pay for improved drug safety monitoring, and give the FDA increased authority for the safety of drugs once they are already on the market, such as requiring drugmakers to add warning labels and conduct post-marketing authorization studies.

House was tougher on drug industry