Sunday, June 12, 2005

Top Republican Says New FDA Drug Safety Board Too Pro-Industry To Protect Americans

The new Drug Safety Oversight Board, established by the Food and Drug Administration, is so "severely biased in favor of industry" as to be ineffective in protecting Americans against dangerous medications.

You might assume that the above criticism comes from liberals. Guess again.

Sen. Charles Grassley (R-IA), chair of the Senate Finance Committee, has joined the fight of FDA whistle-blower David Graham because, as Graham said in a June 8 interview with the Washington Post: "(T)he FDA cannot be trusted to protect the public or reform itself."

The problem, Grassley and Graham attest, is the makeup of the safety oversight board.

In a letter to acting Commissioner Lester M. Crawford, Grassley said 11 of the 15 voting positions on the board are filled by senior managers of the FDA's Center for Drug Evaluation and Research, the same office responsible for reviewing and approving new drugs.

Think about that. The safety oversight board was established, in part, to make the safety review process independent of the drug review process. But the FDA did the exact opposite -- creating a board majority that, to be blunt, would have to admit its own prior judgment was faulty before taking a drug off the market. The board's regulations require at least a two-thirds vote by its members -- 10 out of 15 -- to recommend that the FDA take action.

In his letter to Crawford, Grassley asked: "Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public's well-being, and not to the drugs that they helped put on the market in the first place?"


Grassley and Sen. Christopher Dodd (D-CT) have introduced a bill that would give drug safety oversight responsibility to a board independent of the FDA.

Here's a shocker: Drug industry lobbyists are fighting the legislations, because they are afraid that a truly independent board will focus on drug risks rather than potential benefits.

Heaven forbid that a safety oversight board actually concentrate on safety.


Shocker #2: Janet Woodcock, FDA acting deputy commissioner for operations, defended the safety board as independent. But she did so with the sort of vague, pleasing answer that critics have come to expect from the Bush Administration.

"The safety board will be able to meet quickly, deliberate and make some strong recommendations if needed," she said.

It's a nice summary of the board's intended purpose, but the key words are "if needed," and people like Grassley and Graham don't buy that a pro-industry board will make that determination enough to protect the nation.


Anonymous Anonymous said...

On its face, this does not seem like the way things should be done.

8:07 AM  
Anonymous Anonymous said...

I do not see how you have demonstrated that the safety board is severely biased towards the pharmaceutical industry. What you have shown is that there is an inherent discord between the members roles prior to the drugs being taken to market, and post approval safety, which is a legitimate concern. However, just because these people are senior level in the approval process does not make them biased towards industry.

9:15 AM  
Anonymous Anonymous said...

JABBS isn't saying it, Grassley and Graham are.

Perhaps the people in question include a number of former drug lobbyists? That's been the Bush administration's MO elsewhere (like Philip Cooney ...)

12:44 PM  
Anonymous Anonymous said...

And that "discredits" them how? They are paid to do a job. Do you discredit a defense attorney for representing the interests of their client just because they are paid to do so?

1:57 PM  
Anonymous joe said...

Please tell me you aren't suggesting that the FDA should favor industry over product safety ...

Grassley and Graham think that the FDA should live up to its promise of independence between those that recommend approving drugs, and those who have to decide if a drug should be taken off the market.

It seems pretty reasonable to me. Why bother setting up the board, and the notion of independence, if you aren't going to follow through on it?

2:45 PM  
Anonymous Anonymous said...

I never suggested that the board should be pro anybody. I simply pointed out that just because somebody may, or may not have been a lobbyist for an industry, does not render them incapable of being fair or impartial, which was the suggestion in a prior post.

3:48 PM  
Anonymous Anonymous said...

It is old news to those who have studied the issue that the FDA is really a cartel for the big phamaceutical companies, no worse than the Mafia.
The Safety Board issue only offers us more proof.
Last year, for one example, the FDA shut down ephedra supplements because a single baseball player misused them and died of a heart attack, but at the same time the agency has continued to ignore dangerous prescription drugs of the pharmaceutical giants that injure and even kill thousands of individuals each year.
The FDA fails to endorse nutritional supplements increasingly documented by medical science to prevent or inhibit various terminal diseases, because to do would so might cause fewer people to need the drugs of the big pharmaceutical companies designed to prevent such illnesses once they've already been contacted.
It is really sickening. It is perhaps an epidemic of a money-based democratic economy.

12:36 PM  
Anonymous Anonymous said...

It does not render them unable to be fair or impartial, but if the FDA says it wants an independent safety board, then they should create an independent safety board.

Seems that they wanted to call it independent, but didn't follow through -- possibly because they didn't want to offend the drug industry money going to the GOP -- and now a Republican, Grassley, is trying to do something about it.

1:06 PM  

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