Sen. Grassley Blasts FDA In Pharmaceutical Executive Interview
In an extensive interview published in the September edition of Pharmaceutical Executive, Senator Charles Grassley, a long-time critic of the Food and Drug Administration (FDA), blasts the agency for putting patients last and pharmaceutical companies first. Following are some of his more biting comments.
- The FDA Is More Worried About PR Than Patients: “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.”
- The FDA Is Too Cozy With Pharma: [I]t 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.
- Drug Ads Don’t Effectively Communicate Drug Side Effects: “I’ve watched so many of these commercials and feel that the dangers [of drugs] are not as obvious as they ought to be. When the person presenting the commercial gets to the lines about safety, they go very very fast. It just seems to me that that compromises the safety issues of some drugs. And so I’m not looking at it from the standpoint of whether there ought to be drug advertising or not. I’m looking at it from the standpoint of it being effective advertising regarding drug safety. We have asked the Government Accountability Office to examine DTC advertising on safety issues. A report should be out early next year.”
(The current edition of Pharma Marketing News features a very interesting analysis of risk vs. benefit information in print DTC ads. It’s worth a read. Click here to access the article.)
Click here to read Grassley’s remarks. I’ll be focusing on the topic of the current communications enviornment faced by the FDA in the next edition of my firm’s newsletter, Envisioning.
