The Assault on Generics

By Viveca Novak/Washington

For nearly as long as the Sunshine State has attracted retirees, it has been a rich market for DuPont Pharmaceuticals. The company sells close to $50 million of its blood thinner Coumadin to heart and stroke patients in Florida each year, and it had the market all to itself until 1997. Then the U.S. Food and Drug Administration approved Barr Laboratories' generic version, and suddenly DuPont's monopoly was threatened.

But for three years running, DuPont has managed to shut Barr out. This month it quashed a bill that would have made it easier for Florida patients to get generic substitutes for certain brand-name prescriptions. As a result, Floridians are paying at least 25% more for their blood-thinning medication than they would if they had access to the generic version. And the cost of the drug keeps going up.

As Congress and the presidential candidates fret over the high prices of prescriptions, the drug companies have been launching rear-guard actions in the states to protect their profits. Florida is one of about 30 states in which makers of brand-name drugs, often led by DuPont, have pushed to limit patient access to some generic versions. At times the generic companies have pushed back and won. In 1998 Minnesota gave its consumers access to all the cheaper substitutes approved by the FDA.

But in other states, the brand-name companies have retained the upper hand. DuPont's allies in Florida, for instance, killed this year's effort by its rival Barr to let pharmacists substitute generics, including its blood thinner warfarin, for four brand-name drugs unless a doctor objects. Minutes after the state senate passed a bill backing Barr's plan in April, a flotilla of DuPont lobbyists converged on Speaker John Thrasher's office. Thrasher had earlier asked Republicans studying the bill to oppose it. Now he refused to let it come up for a vote. With the clock running, allies of Barr hatched a plan to deny Thrasher a pet bill of his own unless this one was attached. But at the last minute they veered away, unsure of their support.

Three years ago in North Carolina, DuPont helped ram through the legislature a bill requiring doctor's approval for the substitution of generics like Barr's warfarin. "We are only concerned about patient safety," says DuPont spokesman Thomas Barry. Some physicians support DuPont's position because they say warfarin is a tricky drug and doses must be carefully calibrated. The implication is that the brand names do a better job of that. But the FDA says the generic version is safe and has admonished DuPont more than once for stoking false fears in its promotion of Coumadin.

DuPont isn't the only company throwing tacks in the path of its generic rivals. Just last week Novartis, maker of the blockbuster anti-rejection drug Neoral, for organ-transplant patients, failed to get a Massachusetts state drug board to limit sales of Neoral's equivalent, generic cyclosporine. Ohio's senate, egged on by Novartis, has held 11 hearings in two years on this issue. "They have been bloody dogged on this," says R.J. Tesi, an executive with generic cyclosporine maker SangStat Medical Corp. He points out that patients spend $5,000 or more on Neoral yearly, while the generic cyclosporine costs 20% less. Some patients stop taking the medication because they can't afford it--and lose their transplants.

The generic-drug makers feel as if they're playing a game of 50-state Whack-a-Mole, never knowing where another amendment or rule pushed by their rivals is going to pop up. Take Illinois: last year Barr and its allies persuaded legislators to dissolve a state panel that had delayed marketing of some FDA-approved generics, but Governor George Ryan vetoed the bill. Still, all sides worked out a compromise to give immediate approval to most generics. Barr's lobbyists relaxed. Too soon, it turns out. A month ago, an amendment was quietly tacked onto a new bill to help the poor pay for prescriptions. The rider makes it harder to substitute generics like warfarin. Ryan is set to sign the bill.

--By Viveca Novak/Washington