WASHINGTON (Reuters) - A key U.S. lawmaker said on Thursday he had not yet seen a workable approach to creating an approval pathway for generic versions of expensive biotechnology medicines.
By Lisa Richwine
WASHINGTON (Reuters) - A key U.S. lawmaker said on Thursday he had not yet seen a workable approach to creating an approval pathway for generic versions of expensive biotechnology medicines.
House Energy and Commerce Committee Chairman John Dingell said in an interview he was working on the issue but was not ready to embrace any of the various legislative proposals on the medicines, also called biologics.
"There are a lot of people running around here saying they've got a solution to the problem. I'm not satisfied that's so," Dingell said in an interview for the Reuters Regulation Summit.
!ADVERTISEMENT!"Nobody has told me yet that they have something that would really satisfy me as to, first of all, protecting the consumer and assuring that in fact this was identical with the way (the brand-name drug) worked in the body," the Michigan Democrat added.
The Republican administration of President George W. Bush surprised many by calling on Monday for legislation enabling the FDA to approve generic biologics, which are made from proteins from living cells.
Copycat versions could provide big savings for insurers and patients -- some of whom pay thousands of dollars for branded biotech drugs, which are typically injected because they involve large proteins that are destroyed by the stomach.
The medicines treat conditions like anemia, rheumatoid arthritis, hepatitis and cancer.
Generic companies such as Barr Pharmaceuticals Inc, Hospira Inc and Teva Pharmaceutical Industries Ltd are pushing for legislation the Food and Drug Administration says it needs to approve the drugs in the United States.
Sen. Charles Schumer, a New York Democrat who co-authored a biologics bill, said FDA Commissioner Andrew von Eschenbach had approached him this week about working on a plan.
Biotech companies have warned that biologics are much more complex to copy than traditional, chemical-based drugs, but recently have said they could support legislation creating an approval path.
Key areas of dispute include the amount of market exclusivity that a brand-name company gets and how big a study a generic company would have to conduct for approval.
Von Eschenbach, speaking at the Reuters summit on Tuesday, called for legislation giving the FDA flexibility to determine testing requirements because products have varying levels of complexity.
"You can't think of this in terms of one-size-fits-all," he said.
Another major sticking point is so-called interchangeability-- whether generic versions could be automatically substituted for brand-name counterparts.
"We are working on this thing. We're trying to figure out what can be done because there are advantages to be achieved for consumers," Dingell said.
But he added that "you've got to be satisfied that it will work. You have to be satisfied that it has the political support so it can become law. You have to be satisfied that it will work when you've got it reported out and the president has signed it."
"I don't see those requirements being met with regard to the biological generics," he said.
(For summit blog: http://summitnotebook.reuters.com/)
(Editing by Tim Dobbyn)
