FDA To Slightly Redraw Labeling Guideline

Food and Drug Administration officials said they will make some subtle shifts in their proposed labeling guidelines for blood pressure pills. But at this morning's meeting of the Cardiovascular and Renal Drugs Advisory Committee, they indicated the changes will not be enough to stop the drug industry from using the new guidelines to market pricier drugs as superior even though they probably have no greater benefit than generics.

Robert Temple, chief of the new drugs division at FDA, said the redrawn Guidance will be published in the federal register, which will give the public time to comment. So I'll wait until that document becomes public before reaching any firm conclusions.

But Temple asked several pointed questions this morning that suggested where he is going with this Guidance. He wanted to know who would do trials about specific outcomes for specific patient subgroups if the FDA didn't provide incentives for the pharmaceutical industry. Specifically, he mentioned the HOPE trial, which was funded in part by companies that make an ACE inhibitor, ramipril. That trial, published in 2000, showed ramipril improved kidney function in diabetics. What that trial didn't ask was whether other drugs, either in its class or other classes like diuretics, did the same thing.

So there you have the bottom line. Unless Temple and his colleagues in the cardiovascular drugs division of FDA make more significant changes than they seemed interested in this morning, the Guidance will allow drug companies like King Pharmaceuticals, whose two patents on rampiril don't run out until 2008 and 2012, to market their drugs as better for diabetics compared to other drugs, even if those other drugs A) are cheaper; and B) are likely to be just as effective for diabetics. Alas, no one will test diuretics in that population since there's not much profit to be made from drugs that cost pennies a day, so we'll never really know.