This may be our best shot for real drug safety reform for years. This is also a “must pass” bill, because it renews the fees drug companies pay to the FDA for drug approvals. This act (the Prescription Drug User Fee Act) which went into effect in 1992 expires on September 30th of this year.
While the bill renews PDUFA, it would also give the FDA more funding and authority to oversee the safety of medications on the market. The bill would require the FDA to do more active surveillance of drugs and would give the FDA more authority to require drug companies to perform follow up safety studies and change a drug’s label.
Now we are hearing that issues like drug importation, food safety and regulation of the abortion drug RU-486 may be tacked onto the bill. Who knows, maybe members will try to also tack on legislation on the Iraq war.
Anyway, we’ll keep everyone updated as we know more. For now, everyone can call their Senators and urge them to support this bill and oppose any weakening amendments. Call now, we only have a 48 hours left!