Generic biotech drugs urged

But opponents doubt cheaper copies' safety

January 28, 2007|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- Marta Ockuly was a week away from gaining health insurance at her new job in Sarasota, Fla., when she was diagnosed with a devastating form of cancer. She quickly began chemotherapy, which drove her leukemia into remission but weakened her body's immune system so much that she required shots of a new kind of drug, made using biotechnology.

Ockuly credits the biotech drug, Neupogen, with helping save her life four years ago, but wishes there had been a generic alternative available for less than the $1,000-a-shot she says hers cost. The high cost of drugs and treatment drove Ockuly to bankruptcy. "It pretty much would have wiped anybody out," said Ockuly, who now counsels cancer patients for the Wellness Community, an international support group.

The high cost of health care is back at the top of Washington's agenda. While President Bush in his State of the Union speech this week recommended changing the tax code to curb spending on health care, Democrats are expected to propose paving the way for cheaper, generic versions of biotech drugs.

Biotech drugs are the fastest-growing category of medicines, treating ailments from heart disease to rheumatoid arthritis.

Biotech drugs are more complicated to make than traditional medicines, so they tend to cost more, sometimes tens of thousands of dollars for a year's prescription. Among the most popular are insulin and human growth hormone.

Democrats argue that generic versions would slash these prices, just as the 23-year-old federal law that fostered production of copies of traditional drugs has done.

"Legislation is essential to keep the new generation of life-saving drugs affordable," Rep. Henry A. Waxman, a California Democrat, said through a spokeswoman. Waxman, who sponsored a law with Utah Republican Sen. Orrin G. Hatch governing generic versions of traditional drugs, called passage of a similar bill for biotech drugs "one of my highest legislative priorities."

But powerful pharmaceutical companies argue that the government would be moving too quickly if it authorized sales of generic biotech drugs.

James C. Greenwood, president of the Biotechnology Industry Organization, is telling lawmakers that the legislation would deter drug makers from developing innovative biotech drugs by removing financial incentives. Greenwood also warns that the science hasn't advanced far enough to copy biotech drugs safely.

In 1984, Congress gave the Food and Drug Administration the authority to approve generic drugs for sale without demanding the same costly studies of health effects required for the originals. That allowed manufacturers to market knockoffs faster and more cheaply.

The FDA says it needs similar authorization before it gives copies of biotech drugs speedy reviews. Deputy Commissioner Janet Woodcock says the process would have to be different from the way traditional generic drugs are reviewed. That's because science hasn't advanced far enough for the agency to establish that the biotech copies are identical to the originals - only to say they are similar.

That's why the FDA calls imitations of biotech drugs "follow-ons," not generics. Likewise, the agency wouldn't allow pharmacists to freely substitute follow-on biotech drugs for originals, as they can do with traditional medicines. A doctor would have to specifically request the follow-on, unless the generic drug makers prove through studies that the original and its imitation are the same.

"We will do what is scientifically valid, and that advances over time," Woodcock said. Right now, she adds, science has only reached the point at which the FDA could safely rule on the follow-ons of simpler biotech drugs.

Traditional drugs are simple chemicals formed when small molecules combine, like a few beads that make up a necklace. Biotech drugs are far more complex, a necklace of many beads that fold into various shapes. They can be created naturally but are usually made through recombinant DNA technology.

Since emerging in the early 1980s, their use has soared. More than 150 are on the market. Sales grew to $33 billion in 2005, a 17 percent increase over the previous year, according to IMS Health, which provides information on the pharmaceutical market. Sales of the drugs are expected to exceed $50 billion by 2010.

Given the sums involved, generic drug makers have begun developing follow-on versions even without a speedy approval process in place. Patents on biotech drugs are beginning to expire, which would give generic drug makers the legal clearance to sell them if they receive the FDA's go-ahead. European countries have established a process, and the generic companies predict Congress will take action.

"It's a matter of when it's going to come, not if it will come," said Carol Cox, a spokeswoman for Barr Laboratories, of Woodcliff Lake, N.J., which is developing versions of Neupogen and 10 other biotech drugs.

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