By Julie Steenhuysen

June 04, 2014

CHICAGO (Reuters) - By law, Dr. Richard Pazdur, the U.S. Food and Drug Administration's cancer drug czar, is not allowed to consider the cost of treatments his agency reviews, only whether they are safe and effective.

But Pazdur is not blind to escalating drug prices and the growing debate over how to place an appropriate value on cancer drugs, which can cost $100,000 a year or more.

"It's very difficult for me to talk about," Pazdur said in an interview at the American Society of Clinical Oncology meeting in Chicago, where the issue of value has been a consistent theme among the world's top cancer doctors.

Instead, he recounts a story about buying his first house in Detroit in 1982.

"I was very nervous. I asked the realtor if I was paying the correct price. She said to me, 'Rick, the price is what anybody is willing to pay for it.'"

In his view, the same applies to cancer drugs.

"Everybody knows that these are expensive drugs," he said. "Obviously, we can't just continue going on with escalating prices of drugs. That's not a regulatory decision or anything profound from the FDA. It's just the reality of the situation."

Pazdur said the solution will likely take "a national dialog" involving all stakeholders - insurers, patients, doctors, lawmakers.

At the ASCO meeting this week, that dialog has already begun. In a forum on drug costs, Dr. Ezekiel Emanuel, the architect of President Barack Obama's healthcare law, said costs can no longer be ignored. Emanuel reminded his well-heeled audience that the median household income in the United States is $52,000.

"It's not a lot of money, especially compared to almost everything we do for cancer patients," he said. Just one costly cancer drug "wipes out the median income household."

And while the FDA may be barred from considering cost, Dr. John Marshall of Georgetown Lombardi Comprehensive Cancer Center, said the agency might reconsider its standards of deciding which drugs offer enough benefit to win approval.

"Is a $30,000-a-month drug that improves survival by 1.4 months effective? By an FDA standard, yes, if it meets the safety and efficacy data bar. But you would never swipe your VISA card for that kind of advantage," Marshall said.

Pazdur said FDA cannot suddenly raise the bar on drug approvals, but he said the treatments he is seeing now, based on better science, are already far more effective than ever.

Since 2012, when FDA began implementing its so-called Breakthrough Therapy Designation program, 45% of the drugs that have been granted that designation have been cancer drugs.

"We're seeing drugs that have higher response rates even in very refractory (drug resistant) populations," he said. "That is really making us look at how we develop drugs and how we evaluate drugs."

Better drugs could translate into a shorter regulatory process, cutting the cost of drug development.

"If we can speed approvals, drugs will cost less," Marshall said.


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