Big Pharma Has Its Way With The FDA Once Again As Regards Drug Safety

Agency Flops And Drops Its Proposed Drug Watch Site, Which Was Intended To Provide Early Warning About Emerging Unsafe Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

In May 2005 the FDA announced that they would establish a new web site, to be called Drug Watch, that would alert doctors and patients about emerging drug safety issues.  One could think of it as the FDA's early-warning system for serious side effects that might be linked to FDA-approved prescription drugs.

As one may recall, this new Drug Watch web site was suppose to be a key part of the FDA's effort to improve its performance in fulfilling its drug safety monitoring role, which was roundly criticized following the September 2004 Vioxx recall.

After details of the FDA's proposed Drug Watch web site were published in the Federal Register back in May 2005 -- and after allowing for the 90-day comment as well as the time required for other administrative procedures -- it was anticipated that the FDA Drug Watch site would be available online in late 2005 or early 2006.

As reported previously, to most people this Drug Watch web site sounded like a step in the right direction for the FDA. But then there is Big Pharma:

The large drug companies oppose the Drug Watch plan because they imagine that there will be unnecessary confusion and "irrational fears" about their respective drugs if patients are given access to early information about potential drug side effects.

In a March 2, 2007 Reuters article by Lisa Richwine we learned that Big Pharma is going to have its way with the FDA, again, and that there will be no Drug Watch web site after all.  According to this Reuters article:

Instead of a "Drug Watch" list, the Food and Drug Administration will place red asterisks next to the names of the medicines on an existing Web page that lists dozens of prescription drugs. Consumers can click on the drug name to link to FDA advisories and other information.

"I feel strongly that such an approach meets our goal" of providing useful information to doctors and patients, Dr. Paul Seligman, associate director for safety policy and communication in the FDA's drug center, told reporters.

The FDA made the change because there was concern about potential confusion between "Drug Watch" and "MedWatch," an FDA program that provides alerts about new information on medical products, Seligman said.

The Reuters article also brought us the rather smug reaction of the pharmaceutical industry about this most recent "flop" by the FDA when it comes to standing up for patients as regards drug safety issues:

Drugmakers are pleased the FDA abandoned Drug Watch and was embracing a more balanced approach, said Alan Goldhammer, associate vice president for science and regulatory affairs at the Pharmaceutical Research and Manufacturers of America industry group.

The new plan "looks at the whole spectrum of information on both drug benefit and risk. That's been one of the points we've tried reinforcing - that one can't look at risk in the absence of benefit," Goldhammer said in an interview.

We encourage you to take a look at the FDA's apparent replacement for the Drug Watch proposal.  You will notice that some currently suspected unsafe drugs, such as Dostinex and Permax, are not even found on this Index to Drug-Specific Information page.

Let us know what you think:  Is this new approach taken by the FDA good for doctors and patients, or good for Big Pharma?

P.S.  In a March 6, 2007 post on his Pharma Marketing Blog, titled "Drug Safety -- A Mere Asterisk to the FDA", John Mack gives his perspective on this decision by the FDA to abandon their purposed Drug Watch web page.  I recommend it.

Comments

[Tom Lamb]

Thanks for your comment and for reading Drug Injury Watch.

The FDA seems to be falling right back into the type of conduct, i.e., capitulation, that allowed Merck to "negotiate" for a prolonged period the wording of revisions to the Vioxx label regarding cardiovascular risks -- while doctors prescribed and patients took Vioxx without having the benefit of the knowledge about heart attacks and strokes that Merck and the FDA had, but did not make publicly available.

One hopes that the ongoing Congressional hearings will bring some much needed reform to the FDA.

Let us know what you think.

Tom Lamb

[Melody]

Pharma has the money--Pharma rules the game. David Willman (LA Times) long ago identified the FDA as Pharma's LAPDOG, not the public's WATCHDOG. At one time, I thought they were merely the "mouthpiece" for Pharma; now I see them not only as the mouthpiece, but as the enabler--in mob-speak, the FDA is the one who pulls the trigger so the Godfather won't get his hands dirty.