Exclusivity's benefits

tool name

tool name

Generic drug makers say 'no' to health overhaul tab

WASHINGTON — Generic drug makers, which have saved Americans hundreds of billions of dollars in the past decade with their low-cost, copycat medicines, don't think they should join other health industries to finance a health care overhaul.

Under the Senate Finance Committee bill approved Tuesday, the generic drug industry would pay $460 million over a decade through additional rebates to the state-federal Medicaid program for the poor.

"That would be very harmful to our industry and our consumers," said Kathleen Jaeger, the president and CEO of the Generic Pharmaceutical Industry Association. She said the higher discounts would result in fewer companies making generics, which could push prices higher.

How to keep new drugs in the pipeline

Congress is considering legislation to establish an abbreviated regulatory pathway for imitative biological products, referred to as "biosimilars." Biologics are large, complex molecules derived from cell cultures, and they have provided medical breakthroughs for various cancers, MS and rheumatoid arthritis in recent years.

There are currently more than 600 biologics in clinical trials for different indications, of which more than 250 target cancers. The U.S. biopharmaceutical industry, including many firms in North Carolina, has been the global leader in biological advances for more than two decades. In enacting a biosimilars pathway, Congress must balance the dual objectives of cost savings with continued incentives for the development of novel biological therapies.

One of the most contentious issues is the data protection period for a new biologic. This is the period after a new product's approval before a biosimilar product can rely on the innovative firm's safety and efficacy data to enter the market

Senators push effort for generic biotech drugs

Biotech drugs that now cost thousands of dollars a month would have to compete with lower-cost generic versions after just five years on the market under a new congressional proposal.

The bipartisan bill introduced Thursday is the latest salvo in a years-long effort to lower the price of biotech drugs, high-tech injectable medications that cost the nation more than $40 billion a year.

The proposal from Sen. Charles Schumer, D-N.Y., and Susan Collins, R-Maine, suggests generic drug makers are gaining traction for their long-sought goal: a speedy, low-cost pathway to market for generic biotech.

Biotech firms battle for time to turn profit

With the nation's $46 billion biological drug market at stake, the war between makers of the pricey biotech medicines and their would-be generic competitors has involved millions of dollars in lobbying, thousands in campaign contributions and uncounted visits to members of Congress. And one noteworthy letter.

The note from the private National Health Council, sent to House leaders drafting health overhaul legislation, said the plea was on behalf of "the more than 133 million Americans living with chronic diseases and disabilities and their family caregivers." It urged lawmakers to protect the makers of high-technology biological medicines against early competition from lower-cost generic copycats.

The letter did not mention that nearly $1.2 million of the council's $2.3 million budget in 2007 came from the pharmaceutical industry's chief trade group and 16 companies that sell or are developing the brand-name biotech drugs.

Patenting human genes thwarts research, scientists say

WASHINGTON — Rapid advances in biology and genetics are raising fresh concerns about the spreading practice of patenting human genes.

The U.S. Patent and Trademark Office has granted patents to at least 4,382 human genes, including genes related to Alzheimer's, asthma, cancer, muscular dystrophy and other serious diseases.

"Twenty percent of the human genes are currently patented,'' said Christopher Hansen, an attorney for the American Civil Liberties Union, which filed a suit last month challenging six patents on two genes that are connected to tests for breast and ovarian cancer.