MALVERN, Pa. -- To more than half a million patients suffering from rheumatoid arthritis or Crohn's disease, Remicade has brought life-changing treatment and relief.
But the drug, a genetically engineered protein produced not by chemistry but by living cells in a manufacturing process that requires 310 discrete steps, also brings a heavy financial burden. The manufacturer estimates that each patient will pay $14,000 to $16,000 a year for Remicade, and that people generally will take it indefinitely.
For those helped by Remicade, made by Centocor Inc., a biotech subsidiary of Johnson & Johnson, the drug represents a realization of the promise of biotechnology -- to treat disease with laboratory-created versions of proteins and other essential building blocks of the body's cells. But for employers, health insurers and the already stressed Medicaid and Medicare programs that pay the bills, the drug represents something else -- a serious threat to their financial well-being.
With complicated and costly "biologics" such as Remicade increasingly seen as the wave of the pharmaceutical future, health care experts warn that they will drive the nation's fast-growing bill for drugs far higher. And that prospect has set off a fierce battle in Washington over the multibillion-dollar question of whether to open the door to lower-cost generic or "follow-on" versions of the pricey biologics.
Faced with a similar problem 20 years ago, when the prices for an earlier generation of drugs skyrocketed, Congress passed the Hatch-Waxman Act -- which allowed makers of generic drugs to copy medications after the expiration of their patents and to sell them without conducting many of the expensive clinical trials and testing procedures that can make brand-name drugs so expensive. Last year, about half of all U.S. prescriptions were for generic drugs, yet those low-priced products accounted for only 8 percent of the nation's drug bill.
Biotech drugs were in early development then, and nobody thought to give the Food and Drug Administration the authority to establish a similarly abbreviated review process for their generic versions.
Now, many believe the science of biopharmaceuticals -- which has produced more than 150 FDA-approved drugs and has another 350 in human clinical trials -- has advanced enough to make possible a parallel shortcut that would get lower-cost biologics onto the market. But others say that because newer biologics are much more difficult to manufacture and pose more safety risks, that prospect should worry the public.
Johnson & Johnson is pointing to its own experience with another product as a cautionary tale: Some patients taking its genetically engineered anemia drug, Eprex, experienced serious side effects after the company started using a new stabilizing chemical, and it took years to fully diagnose the problem.
This issue and more will be debated at an FDA conference next week, one designed to assess whether the expertise of generic-drug makers has progressed far enough to take on biologics.
The major trade associations of brand-name drugmakers say it probably has not. "It's a very different process to reverse-engineer a pill than a biologic," said James C. Greenwood, president of the Biotechnology Information Organization. "With a pill, you can pretty easily discern the chemical makeup and then duplicate the product. But with the larger, more complicated and more variable proteins that make up the biologics, you can very easily get small but significant differences that have clinical effects."
But generic-drug makers -- as well as some insurers and government programs that pay the bills -- argue that the industry is foot-dragging as the science speeds ahead.
"I feel very strongly that we have the science and systems in place to manufacture safe and effective biologics," said Marvin Samson, a vice president of Teva Pharmaceutical Industries Ltd., a generic maker that already produces biologics in Eastern Europe for countries where patent protection is not enforced. "The situation is like in the 1980s with Hatch-Waxman, where the brand-name industry said we didn't have the science and capabilities to analyze their products and reproduce them. We did have the ability then, and we do now."
The Generic Pharmaceutical Association, which represents 120 companies, wants Congress to create a review process for generic biologics soon. "We think that as policymakers understand better what biologics without competition are going to do to Medicaid and Medicare budgets, they'll definitely want a generic option," said Kathleen Jaeger, the GPhA's president.
That opinion is not widely shared in Congress. Both Sen. Orrin G. Hatch (R-Utah) and Rep. Henry A. Waxman (D-Calif.), sponsors of the 1984 law, are not convinced a scientific consensus exists.