Health care bill includes generic path for biologic drugs

McClatchy NewspapersNovember 29, 2009 

WASHINGTON — After decades of suffering as her body gnarled and stiffened from rheumatoid arthritis, Bonnie Cramer began taking a new drug around 2002.

It wasn't a pill, but an injection — a medicine derived from the living cells of a small hamster, blended with human DNA and whipped into a brew that Cramer shot into her body twice a week.

The morning after she took it for the first time, Cramer climbed out of bed without help.

"I took the drug for over six years. During that time felt as though I had no arthritis," Cramer said.

The biologic drug Enbrel cost $2,000 a month, and Cramer, of Raleigh, N.C., says she was lucky to afford it on the health insurance she enjoyed as a state worker.

"I was always amazed at the number of people in my doctor's office who were trying to find ways to afford this drug, who were in the same situation I was in," said Cramer, a former director of the division of aging for the state of North Carolina and national board chairwoman for AARP.

"They had run out of options and they were getting more disabled," Cramer said.

By law, no generic alternatives to Enbrel or any other biologic drug are available in the U.S. because the Food and Drug Administration has no authority to approve them.

Under health care legislation in Congress, however, generic biologic drugs would become legal in this country for the first time — potentially saving patients thousands of dollars in drug costs in the fastest-growing market in pharmaceuticals.

Some of the brand-name biologic drugs, such as those used to treat cancer, can cost nearly $50,000 a year.

The availability wouldn't come immediately, though. The bill would allow brand-name drug companies to have 12 years of exclusivity before generics could come onto the market — a timeframe that some patient advocates argue is unnecessarily long.

"If we don't do something about the costs in this area, we'll simply continue to see this big explosion," said Nora Super, AARP's lobbyist in Washington. "(Patients) will just know they cost a fortune and they can't afford them."

Generic drug companies are eager to invite generic biologic drugs into the U.S. market, but they, too, say the 12-year exclusivity is too long. They were supported in June when the Federal Trade Commission said the exclusivity was unnecessary, and that competition from generics could lower drug costs by as much as 80 percent.

The Obama administration supports a seven-year exclusivity, and an effort by Rep. Henry Waxman, D-Calif., to reduce the time to five years failed last summer in the House.

Pharmaceutical companies and many lawmakers, however, said the industry needs that time to recoup the billions it spends on developing new biologic drugs.

Biologic drugs are different from small-molecule chemical drugs — such as those found in pills — because they are derived from living cells and can comprise thousands of atoms.

It takes $80 million to $150 million to develop a successful, brand-name biologic drug, said Sam Taylor, the president of the North Carolina Biosciences Organization, a trade group. Only a few ever make it to market.

Patients usually take biologics through injections or intravenously. Some doctors and patient advocates say they've seen heartbreaking stories about patients who can't afford the pricey medicines.

Cramer, the patient with rheumatoid arthritis, recalled talking with a fellow patient at her doctor's office and hearing how the woman didn't have the insurance to afford a biologic drug such as Enbrel.

"It was one of those days when you leave the doctor's office with a lot of tears in your eyes," Cramer recalled. "She had no hope of getting this drug."

Debbie Smith, a case manager at the Buddy Kemp Caring House in Charlotte, N.C., a resource for cancer patients, tries to match needy patients with financial resources, including some assistance programs run by drug companies. Still, she said, families often continue to face hardship.

"I've had some patients who can't afford the medication. So, they don't get the treatment," Smith said.

SMALL-MOLECULE VS. BIOLOGIC

Small-molecule drugs often are comprised of dozens of atoms. They can be reproduced through mechanical methods and usually are taken in pill form.

Federal law allows brand-name small-molecule drugs a five-year exclusivity before generics can be made using the same data.

Biologic drugs are derived from living organisms and can be made of hundreds or thousands of atoms.

"It's a very complex process, and it doesn't come out the same every time," said Sam Taylor, the president of the North Carolina Biosciences Organization in Research Triangle Park, N.C.

The Food and Drug Administration has not had a regulatory pathway to develop generic drugs, known as biosimilars, so they haven't been available in the U.S.

The health care bills in both the Senate and House would allow that pathway.

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