[Ip-health] Reuters: FDA cancer chief says 'escalating' drug prices can't continue

Thiru Balasubramaniam thiru at keionline.org
Mon Jun 23 08:07:04 PDT 2014


FDA cancer chief says 'escalating' drug prices can't continue

(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 a year.

"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

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

"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
stakeholder - 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
<http://www.reuters.com/people/barack-obama?lc=int_mb_1001> 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

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 percent 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.

(Reporting by Julie Steenhuysen; Editing by Matt Driskill)

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