April 30, 2007 – 7:45 p.m.
With Congress taking its first stab in five years at rewriting the drug approval process, the Senate began considering a bill that could become a magnet for all sorts of prescription drug proposals.
The measure (
But it’s also a high priority for Democrats in Congress, who have seen other parts of their health care agenda stall.
The bipartisan measure is sponsored by Massachusetts Democrat
But bill supporters will have to fend off attacks from multiple flanks. Enzi acknowledged Monday that the language Kennedy presented as a manager’s amendment won’t be the final product.
“This is a work in progress,” he said on on the floor. “We’re not there yet. We’re close.”
Critics of the bill’s drug safety provisions, led by
Grassley has argued extensively that the bill’s drug safety monitoring provisions do not go far enough. A spokesman for Grassley said staff were working on addressing a number of his concerns and he would likely offer a floor amendment on drug safety.
Other amendments could come from supporters of a prescription drug importation bill (
Other lawmakers have discussed adding language that would legalize generic biological products, also known as “biosimilar” drugs and follow-on biologics. Unlike many drugs, biologics are complex biological molecules difficult to replicate and do not currently have generic alternatives. A generics provision would treat them more like other drugs, in that once their patents expire, generics makers could move in with copies.
The bill’s provisions to tighten FDA control over direct-to-consumer advertisements for drugs could also be a target for amendment. Opponents of the ads claim they artificially drive up demand for drugs and interfere with the doctor-patient relationship.
Foes of giving the FDA extended authority call it a First Amendment issue.
“I’m not going to go down without a fight when this bill hits the floor,” Roberts told Kennedy during the markup. “I do not think it’s constitutional.”
Roberts likely will have an ally in
Democrats have promoted a broad range of health care proposals since taking the reins of Congress in January but so far have had little success in enacting their agenda.
Among the items:
• Language allowing the importation of drugs from several countries faces a veto if passed as stand-alone legislation and is in search of a must-pass bill to carry it into law.
• Embryonic stem cell research legislation (
• A bill (
• Health information technology legislation has not yet been marked up, after being passed in both chambers last year but never making it to conference.
The FDA program that Kennedy’s bill would reauthorize reviews and monitors the development of new pharmaceutical products and monitors the safety of the drugs once they are in use.
Industry fees paid to the FDA as part of the program guarantee expedited review times to get drugs to market faster.
Critics of the bill argue that the industry fees have become such a critical part of funding as to leave the FDA beholden to the industry. Kennedy has said he would like to give the program more direct government funding but that the fees are a fact of life for now.
His legislation includes language that would reauthorize a similar program for the approval of medical devices, which also collects user fees from device makers to expedite the approval process.


