Healthy Skepticism Library item: 2211
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Richwine L.
Pediatric Drug-Test Incentives Clear House
Reuters 2001 Nov 15
Full text:
WASHINGTON (Reuters) – The U.S. House of Representatives on Thursday voted to renew a program that has spurred an explosion in pharmaceutical industry research of medicines in children for an additional six years.
The House passed the legislation by a vote of 338-86 despite some criticism from Democrats the incentives for drug makers, sometimes more than $1 billion, were too generous.
The Senate unanimously passed a similar bill in October. Negotiators now must meet to resolve differences. The current program expires Jan. 1.
Created in 1997, the ``pediatric exclusivity’‘ program protects drug products from generic rivals for six months after their patents expire in exchange for research in children.
In the six years before the program began, only 11 studies were completed. With the incentives, drug makers have started or completed nearly 400 pediatric studies, with some already yielding valuable information for doctors on how to treat kids, the bill’s supporters said.
``Better informed decisions are being made and children are being better taken care of,’‘ said California Democratic Rep. Anna Eshoo, who co-authored the bill with Pennsylvania Republican Rep. Jim Greenwood.
But Rep. Henry Waxman, a California Democrat who helped write the legislation that created the incentive, said he now thought it was too costly. In one case, a company was expected to reap $1.2 billion in sales for studies that cost $2 million to $4 million, he said.
``The cost has exploded beyond any relation to the cost of a drug company doing the pediatric studies,’‘ he said, suggesting the government instead pay twice or up to five times a firm’s investment.
While drug firms gain rewards for six months, consumers pay higher prices without cheaper, generic competitors, he said.
And some drugs that receive the six-month protection do not get prompt label changes to reflect new information learned from the studies, Waxman said. The bill’s supporters said it included provisions to speed that process.
The House measure also aims to block Bristol-Myers Squibb Co. from using a pediatric study to gain an extra three years of protection for its blockbuster diabetes pill Glucophage, said a congressional aide who requested anonymity.
The bill would permit generic firms to sell a copycat drug during the three years after the exclusivity expired, the aide said. The generic forms would not be permitted to carry information from pediatric studies on their labels.
Generic drug makers said Bristol-Myers was lobbying vigorously to have the provision changed during negotiations by a House-Senate conference committee.
``We will be watching very carefully as the bill goes through conference,’‘ said Jake Hansen, a vice president for generic drugs maker Barr Laboratories Inc. .
A Bristol-Myers spokesman was not immediately available for comment.
The House bill also would create a fund for pediatric studies of off-patent drugs, which are not eligible for the six-month exclusivity.
