The FDA sides with PHARMA over patients.
Let me rephrase that .... FDA isn't just siding with PHARMA over patients ... it is going behind Congress' back, usurping Congressional power, in order to do it!
The old saying goes, "Laws are like sausages. It's better not to see them being made."
Well, it's official: making laws is much more disgusting than making sausages.
Why you may ask? Because the Unelected Bush-Appointed Bureaucrats in the FDA are taking it upon themselves to rewrite the laws after Congressional intent was made LOUD and CLEAR when they passed them!
Essentially unelected bureaucrats are saying "Thanks but no thanks" to Congress's law regarding who should held accountable for drug label warnings.
It's the Bush Administration's way of shielding PHARMA and the drug companies that they represent from any accountability whatsoever.
More below the fold...
Here is what happened and should be Law:
Last year President Bush signed into law The Prescription Drug User Fee Reauthorization Act (PDUFA), H.R. 3580.
This act creates new federal safety requirements for drug companies, and Congress was very clear that the bill does not change the burden on the drug companies to warn of a drug’s hazards.
That duty remains squarely where it belongs---on the drug company, who is in the best position to warn about problems associated with the drug.
The Rule of Construction, which is included in Section 901, makes clear that Congress is not altering the responsibility of the manufacturer to promptly update its drug label when the manufacturer becomes aware of safety information that should be added to the label. But it still gives the FDA the authority to require label changes and even if the FDA does not act, the burden still remains on the drug company to update its warning label.
Under these regulations, a drug company is required to revise its label to include warnings about risks that may be associated with the drug as soon as there is reasonable evidence of that risk. Although the company must notify FDA of the change, it is not required to wait for FDA’s approval before making such a labeling change. The theory is that consumers should be made aware of a drug’s risk at the earliest possible moment.
The provision also makes clear that the burden of updating the warning label falls squarely on the drug companies.
This is the first time that Congress has said anything about labeling. Previously, all labeling requirements were governed by FDA regulations only.
Read The Senators and Representatives Comments Here
The drug companies fought and lobbied hard to include language that the Congress specifically left out of the final bill. That language, referred to as the Burr amendment and included in the Senate version of the bill (S.1082), would have shifted the burden of making labeling changes from the drug manufacturers to the FDA.
.
.
Instead ... here is what actually happened after Bush signed the bill and the FDA was charged with setting standards to enforce it.
Despite the legislative victory that patients and consumers won over the PHARMA lobby in Congress, the FDA completely undermined Congress by sticking in essentially the BURR AMENDMENT - which was considered and defeated by Congress - back into the bill.
It almost seems like electing a Democratic Congress in 2006 has been worthless since we don't have a Democratic President to make sure the agencies are following the law ... instead of writing their own.
It begs the question ... why even bother having Congress if Federal Agencies are going to Re-write the Laws to reward Corporate lobbies anyways.