Should FDA Hold 'Me-Too' Drugs To A Higher Standard?

Pity, pitavastatin.

A year and a half ago, this cholesterol-fighter, sold as Livalo, was approved by the Food and Drug Administration for sale in the United States. By that time, though, the statin Zocor, for years Merck's best-selling medicine, and Pravachol, a hit for Bristol-Myers, had lost patent protection and were available as cheap generics. Pfizer's Lipitor was still going strong for people who wanted a brand name.

So who needed Livalo?

Many doctors and patients say that having more drugs in a category is a good thing. Even drugs used for the same sorts of treatment differ chemically. Patients may get better results on one drug or have fewer side effects on another. And Livalo's maker said the pill was well suited for patients whose treatment was complicated because of other illnesses.

But an editorial by a doctor and pharmacist at Brigham & Women's Hospital in the latest issue of JAMA says that after a few drugs in a category are approved, the later "me-too" medicines don't offer all that much benefit and come at a steep societal cost. The authors lead with the example of pitavastatin.

The editorial argues that too many choices can make decisions by doctors and patients overly complex. And a focus on me-too drugs hurts pharmaceutical research and development, as well as leading to more spending on marketing.

Once an inexpensive generic drug in a class becomes available, the authors write,"the benefits of approving a new drug in the same class are almost certainly outweighed by its downsides." A big downer then, the editorial says, is that the FDA has to waste a lot of time and energy reviewing marginally different medicines.

Those arguments against me-toos may be pretty tough for capitalists to swallow. And Pfizer's new CEO Ian Read defended me-too drugs recently, as Forbes' Matthew Herper reported.

The editorial proposes a new approach to regulation that would sort of split the difference. Let the Food and Drug Administration review the first me-too drugs in the usual way. Typically that would mean clinical trials comparing them to a placebo or studies that show they're no worse than existing medicines.

But once a generic becomes available, new drugs in the class would have to show they are superior to existing medicines to win the FDA's OK.

Would it help? Hard to say. But one thing's for sure. Nothing like this could happen without big changes in federal law covering the FDA. And don't hold your breath waiting for that to happen.

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