BY DIANE BARTZ | Washington | Reuters.com — Generic drugs would have an easier path to U.S. markets under a bill due to be introduced in the Senate, said Democratic Senator Jeff Bingaman, a sponsor of the bill.
The bill also has the support of Republican Senator David Vitter and will be introduced on Wednesday, Bingaman’s office said.
It would amend the 1984 Hatch-Waxman Act, which was supposed to empower generic drug companies by allowing them to challenge pharmaceutical patents if they thought they were weak.
If the generic company challenged a drug patent and won, it was rewarded with a 180-day window of exclusivity to sell a generic.
However, one result of that half-year of exclusivity is that brand-name and generic companies will settle a patent lawsuit but sometimes make a deal in which the generic company will stay out of the market for a period of time, according to critics of the practice.
Meanwhile, no other generic may come to market.
In some cases, the brand-name company paid the generic company to delay production, a type of deal the Federal Trade Commission calls “pay for delay.”
The Bingaman-Vitter bill would permit any generic company that successfully challenges a drug patent to enter the market, allowing more than one generic company to come to market.
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