Let the FDA Do Its Job? I Don't Think So.

What planet does Diane Bieri live on? It’s certainly not on the planet earth that I live on. In her commentary, Opposing view:  Let FDA do its job, Ms. Bieri goes on and on about how the outcome of a U.S. Supreme Court case will undermine the FDA and it’s the patients who will suffer.

Ms. Bieri claims that we should not “ignore the FDA’s scientific expertise,” and “we should empower the FDA to accomplish the job Americans expect.”

As an “American” here’s what I expect from the FDA. I expect the FDA to not allow drug research studies to be ghost written for the doctors by the drug companies. I expect the FDA to inspect foreign drug plants. I expect the FDA to not approve drugs that have known potential adverse side effects without comprehensive warning labels. I expect the FDA to not allow drug makers to dictate when a drug be recalled that has reports adverse effects or deaths. I don’t expect to have the FDA run by the drug companies.

Ms. Bieri continues, “Now, lawyers are trying to second-guess FDA’s expertise regarding the way to warn about potential drug risks.” All I can say to that comment is, thank God for lawyers! Historically the drug companies will not issue a recall or change a warning label until attorneys get involved and file lawsuits on behalf of patients who have suffered from adverse events or have died.

The drug companies are terrified of losing revenue.  If, we as patients are more informed about potential adverse effects, we may decide that all of those glorious benefits that we see in the polished television commercials and glossy magazine ads are not worth the risk. A patient who makes an informed decision has the ability to affect the drug companies’ bottom line.

In light of the heparin debacle, the ghost written Vioxx studies and the Vytorin and Zetia mess, I find it appalling that anyone thinks the drug companies need less regulation and that the FDA as it exists today is functioning in the best interests of patients.

Oh, wait a second…Diane Bieri is senior vice president and general counsel of PhRMA (the Pharmaceutical Research and Manufacturers of America).