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

Ruth Lopert ruth.lopert at gmail.com
Mon Jun 23 16:28:50 PDT 2014

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

Let's face it - nothing short of regulating prices - either directly or
indirectly through the application of 4th hurdle process - is going to make
a damn bit of difference.
And the notion that speeding drug approvals will reduce costs is frankly


On Tue, Jun 24, 2014 at 1:07 AM, Thiru Balasubramaniam <thiru at keionline.org>

> http://www.reuters.com/article/2014/06/01/us-health-cancer-fda-idUSKBN0EC13W20140601
> 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
> 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
> 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
> 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 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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