Henry Waxman: “before the Greenwood-Eshoo bill which is now under consideration, there was a law called the Greenwood-Waxman bill. It…”

“before the Greenwood-Eshoo bill which is now under consideration, there was a law called the Greenwood-Waxman bill. It was passed in 1997. It was an attempt to get the pharmaceutical companies to do studies on the dosage and the reactions of drugs for children. I supported that bill, as the original cosponsor, but I think it was a mistake because we are overpaying for the work of the pharmaceutical companies to test for children. The cost of exclusivity, which was the price we said we would pay for them to do these tests, has exploded beyond any relation to the cost of a drug company doing the pediatric studies. In the case of one heartburn drug, exclusivity provided between a 30,000 and a 60,000 percent return on the company's investment. The trial was estimated to have cost between $2 and $4 million. The exclusivity is estimated to be worth more than $1.2 billion. In turn, this windfall contributes to skyrocketing insurance premiums, rapid growth in Medicaid budgets and the soaring out-of-pocket costs for seniors on Medicare. As with each of the delays the drug companies use to postpone generic competition, each time we extend patents or exclusivity, it costs patients money. If we look at just 25 more drugs that are coming up for exclusivity soon, this law will add at least $11 to $12 billion to the Nation's health care bill.”