By Ken Dilanian, USA TODAY
WASHINGTON - Senators who raised millions of dollars in campaign
donations from pharmaceutical interests secured industry-friendly
changes to a landmark drug-safety bill, according to public records and
The bill, which passed 93-1, grants the Food and Drug Administration
broad new authority to monitor the safety of drugs after they are
approved. It addressed some shortcomings that allowed the painkiller
Vioxx to stay on the market for years after initial signs that it could
cause heart attacks.
However, the powers granted to the FDA in the bill's original version
were pared back during private meetings. And efforts to curb conflicts
of interest among FDA advisers and allow consumers to buy cheaper drugs
from other countries were defeated in close votes.
* A measure that blocked an effort to allow drug importation passed,
49-40. The 49 senators who voted against drug importation received about
$5 million from industry executives and political action committees
since 2001 - nearly three quarters of the industry donations to current
members of the Senate, according to a USA TODAY analysis of data
compiled by two non-partisan groups, Center for Responsive Politics and
* Sen. Pat Roberts, R-Kan., said he demanded removal of language that
would have allowed the FDA to ban advertising of high-risk drugs for two
years because it would restrict free speech. Roberts has raised $18,000
from drug interests so far this year, records show, and $66,000 since
2001. His spokeswoman, Sarah Little, said he "takes great pains to keep
fundraising and official actions separate."
* Sen. Judd Gregg, R-N.H., claimed authorship of a change that reduced
the FDA's power to require post-market safety studies. He said he wanted
to target drugs only if there was evidence of harm. Gregg has raised
$168,500 from drug executives and PACs since 2001 and sided with them in
four key votes.
* The bill's chief sponsors - Sens. Edward Kennedy, D-Mass., and Mike
Enzi, R-Wyo., - agreed after consultations with industry officials and
others to modify a proposal that all clinical drug studies be made
public, said Craig Orfield, Enzi's spokesman. Under the change, only
those studies submitted to the FDA would be available.
Enzi took in $174,000 from drug interests since 2001; Kennedy, $78,000.
Their spokesmen said the money did not influence them.
Senators also voted down an amendment that would have made it harder for
scientists who have accepted money from a drug company to advise the FDA
on drug approval applications from that firm.
"It's not that money buys votes," said Sen. Bernie Sanders, I-Vt., the
lone vote against the bill. "But you have a culture in which big money
has significant influence. Big money gains you access, access gives you
the time to influence people."
Orfield, Enzi's spokesman, said compromise is necessary in the Senate,
where 60 votes are needed to overcome any single senator's objection.
"Our objective is to get something that can pass," he said.
The pharmaceutical companies spend more money on lobbying than any other
single industry - $855 million from 1998 to 2006, according to the
non-partisan Center for Public Integrity.
"I don't think there is any lobbying group in town that has the clout of
the drug industry," said Ron Pollack, director of Families USA, a
left-leaning consumer advocacy group.
The biggest drug trade group, Pharmaceutical Research and Manufacturers
of America, praised the bill after it passed. The group's spokesman, Ken
Johnson, said its critics "never point out that a great deal of this
money is spent trying to defeat bills ... that are designed to cripple
The bill, which now goes to the House, was based in part on the
recommendations of a report by the Institute of Medicine, a division of
the National Academy of Sciences. The Institute was asked by the FDA to
examine drug safety in the wake of the scandal over Vioxx, which Merck
withdrew from the market in 2004 amid evidence that the drug put users
at increased risk for heart attack and stroke.
The report offered two dozen recommendations for improvement. Chief
among those was that Congress should grant FDA the power to require a
system of post-market surveillance, which the Senate bill would do.
But two other key recommendations were not followed in the measure:
That FDA should have the power to ban consumer advertising for the first
two years of a drug's market life; and that FDA scientists who
investigate post-market side effects should work in an office separate
from those that approve drugs initially.
The bill "does not sufficiently address the underlying problems," said
Sen. Chuck Grassley, R-Iowa, who in recent years held hearings featuring
FDA whistle-blowers who said their concerns about drug safety were