As chairman of the Senate Finance Committee, Senator Charles (Chuck) Grassley, a Republican from Iowa, wields enormous clout
in Washington. His committee oversees taxes, international trade, Social Security, and Medicare. Grassley keeps close tabs
on agencies charged with executing Congressional mandates, including FDA. If it cozies up too tight with the industry, or
downplays safety data that he thinks consumers need, the self-described "common-sense Iowan" says he "sinks his teeth in"
and doesn't let go until the problem is solved.
The federal government spends hundreds of billions of dollars on prescription drugs each year, and Grassley is determined
that US taxpayers will pay only for safe and effective medicines. But investigations and reports by whistleblowers have convinced
the senator that FDA does not protect the public as it should. He has accused the agency of "sweeping safety data under the
rug" when it looked at antidepressants for children, ADHD drugs, and Merck's painkiller Vioxx (rofecoxib). Not to mention
the "runaround" he gets when he asks for information on the side effects of Ketek (telithromycin), an antibiotic by Sanofi-Aventis.
Grassley backs legislation to overhaul FDA's drug-safety reviews, liberalize curbs on drug imports, and eliminate conflicts
of interest. He says safety comes up short in DTC ads, and he wants FDA to better protect patients in clinical trials.
Pharmaceutical Executive's Washington correspondent Jill Wechsler recently discussed these and other concerns with Senator Grassley. The Senator emphasized
that FDA needs new permanent leadership, but hedged on whether he thinks Andrew von Eschenbach is the right man for the job.
Those he does like: whistleblowers great and small.
Pharm Exec: Why do you think FDA is in trouble, and what would you do to fix it?
Grassley: As a starting point, Senator [Christopher] Dodd and I have introduced legislation that offers some improvements. One bill
would require that all clinical trials—both positive and negative—for all drugs would be posted on the Internet so that all
the information would be made public. The other bill would make the Office of Drug Safety [recently renamed Office of Surveillance
and Epidemiology] entirely separate from the Office of New Drugs.
That's the legislative piece. From the standpoint of the agency itself, in most of the last six years, it hasn't had permanent
leadership. So getting a commissioner that will do the job right, and getting him in there full-time, is important.
You have talked about a broader cultural problem within FDA. Why is that a concern?
There is a culture within the FDA that's more worried about its public relations than it is about patients. Now I can say
the same thing about the FBI, and I have. It may not just be an FDA problem, but a culture problem in all government. You
see it, for instance, when the Office of New Drugs approves something, and the Office of Drug Safety raises questions about
it. The Office of New Drugs doesn't want egg on its face, so it tries to squash the controversy.
In the end, you lose proper respect for the scientific process. For a non-scientist like me, that means if you have a good
idea, it should be subject to peer review so that the science will prove if it's right or not. In the case of FDA, the key
issue is whether the drug is safe and effective. But dissident points of view are not getting proper respect. Events have
proven that they were right: We see that Vioxx is off the market and that antidepressants for kids have a black box. But the
scientific process has been compromised, and it's all about the public relations of the organization.
And lastly, it seems to me, the relationship between FDA and pharmaceutical companies is too cozy. We see evidence of this
in some of the telephone notes and e-mails we've had access to. It's just not right. The only person that should be across
this table from the FDA is John Q. Public. It seems like FDA officials see themselves too much as facilitators working with
the drug companies—instead of regulators.