WASHINGTON, April 7 — Senior members of Congress from both parties are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year.

Prospects for the legislation have increased since Democrats took control of Congress this year. Consumer groups, employers and insurers are lobbying for the bill, which they see as a way to hold down health costs.

The proposal faces formidable scientific and political obstacles. Brand-name pharmaceutical companies contend that biotechnology products, made from cells and living organisms, are so complex that a copy will never be identical to the original and therefore cannot be certified as safe without testing in humans.

Biotech medicines are the fastest-growing category of health spending, with sales of $40 billion last year, up 20 percent from 2005, according to IMS Health, a market research company. More than 400 biotech products are in the pipeline, for more than 100 diseases, including cancer, AIDS, diabetes and Alzheimer’s.

Conventional drugs are synthesized by putting atoms together from basic chemicals and are often in pill form.

Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion.

Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original.

Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.

But Dr. Woodcock said: “Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.”

Many biotech drugs are effective but expensive. Avastin, a cancer treatment made by Genentech, can cost $4,400 to $8,800 a month, with a maximum cost of $55,000 a year for people who qualify for the company’s patient assistance program.

Cerezyme, a drug made by Genzyme for Gaucher disease, costs $200,000 a year. Enbrel, made by Amgen for rheumatoid arthritis and psoriasis, costs an average of $16,000 a year.

Biotech treatments for multiple sclerosis range in price from $16,000 to $25,000 a year. “Many patients are denied access to these important drugs because even the co-payments can reach thousands of dollars a year,” said Arney Rosenblat, a spokeswoman for the National Multiple Sclerosis Society.

Consumers save billions of dollars a year by using low-cost generic versions of conventional drugs, which are approved by the government under a 1984 law.

One author of the 1984 law, Representative Henry A. Waxman, Democrat of California, is pushing a bill that would authorize the Food and Drug Administration to approve safe, lower-cost versions of biotechnology drugs.

Senators Charles E. Schumer and Hillary Rodham Clinton of New York, both Democrats, have introduced an identical bill, with support from several Republicans, including Senators Susan Collins of Maine and David Vitter of Louisiana.

The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.

The debate over biotech drugs is filled with paradoxes. Brand-name drug companies, which have for years criticized the regulation of drug prices in Europe, now point to Europe’s strict regulation of “follow-on biologics” as a possible model for the United States. Democrats, who have often criticized the F.D.A. as lax in enforcing drug safety laws, now say they trust the agency to decide whether copies of biotech drugs are safe and effective, without the full range of tests required for new products.

The Widening College Loan Scandal

Congress needs to address the college loan scandal that has unfolded since New York’s attorney general, Andrew Cuomo, began to investigate the troubling — and possibly illegal — payments to universities that steer students to so-called preferred lending companies. These kickbacks are part of a wider pattern of shady dealing that, we now find out, reaches into the federal government as well.
The Times reported last week that a senior official at the Department of Education who helped oversee the federal student loan program held shares of the parent company of the student loan company Student Loan Xpress. That came one day after financial aid officials at three universities that listed Student Loan Xpress as a preferred lender — Columbia University, The University of Texas at Austin and the University of Southern California — were found to have sold shares in the company. The official at Columbia, who earned more than $100,000 on the sale, bought his shares for about $1 each and sold them for about $10.
These cases show what lenders will do to win a slice of the business — last year students took out $85 billion in loans — and the all-too-frequent willingness of universities to go along. Financial aid officers are offered gifts and trips, and universities are offered hundreds of thousands of dollars in payments, if they place a company on their list of preferred lenders that most students use when looking for loans. Universities have also been offered large payments to switch from the government’s student loan program to private lenders whose huge profits are based in part on government subsidies.
This program is clearly in need of serious and immediate reform. For starters, Congress needs to make it illegal for colleges and universities to accept anything of value from lenders. It should also require universities to choose preferred lenders through an open process that guarantees the best rates and treatment for student borrowers.

Hot and Cold

Last week began with a Supreme Court decision declaring that the federal government had the authority to regulate greenhouse gas emissions and all but ordering the Bush administration to do so. It ended with a report from the Intergovernmental Panel on Climate Change — the world’s authoritative voice on global warming — warning that failure to contain these emissions will have disastrous environmental effects, especially in poorer countries, which are least able to defend themselves and their people against the consequences of climate change.
One would hope that these events would shake President Bush out of his state of denial and add his authority to the chorus of governors, legislators and business leaders calling for an aggressive regulatory and technological response to the dangers of global warming. They haven’t. When asked about the Supreme Court decision, the president said he thought he was already doing enough.
He argued further that there was little point in the United States’ doing any more unless other polluters like China acted as well. That ignores the reality that no developing country is going to move unless the United States — which produces one-fourth of the world’s emissions with only 5 percent of its population — takes the lead.
The report from the intergovernmental panel was the second of three due this year. The first concluded with “90 percent certainty” that humans had caused the rise in atmospheric temperatures over the last half-century. The most recent focused on the consequences, few of them positive.
The northern latitudes will have longer growing seasons. But elsewhere climate change will lead to more severe storms, the flooding of tropical islands and coastlines inhabited by hundreds of millions of people, the likely extinction of at least one-fourth of the world’s species and, in poorer countries in Asia and Africa, drought and hunger.
Some of these changes have begun. “We’re no longer arm-waving with models,” said Martin Parry, the co-chairman of the team that wrote the report. But the report also makes clear that while emissions already accumulated in the atmosphere make some damage inevitable, the worst can be avoided if the world’s nations take swift action to stabilize and then reverse emissions.
What must be avoided, the report said, is a rise of 3 to 5 degrees Fahrenheit, the point at which truly devastating effects will begin to kick in. But such a rise is almost inevitable over the next century if the world continues to do business as usual.
The panel’s next paper will discuss alternatives to business as usual. These policies will almost certainly require a major shift in the way energy is produced and used, as well as massive investments in new technologies. They will also be expensive. But what the world’s scientists are telling us, with increasing confidence, is that the costs of doing nothing will be far greater than the costs of acting now.