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 The U.S. Food and Drug Administration chief has made a commitment to
speeding up approvals of cheap generic medicines, which he said is
his agency's main contribution to the Trump administration's push to
cut drug costs to consumers. Gottlieb said the primary effort is
being led by the Department of Health and Human Services.
"So we're doing it on the generic side, but we're also thinking of
doing it on the new drug side," Gottlieb said in an interview on
Saturday at the American Society of Clinical Oncology (ASCO) meeting
in Chicago, the world's biggest cancer conference.
For more ASCO coverage, see: https://www.reuters.com/conquering-cancer
If companies have breakthrough products and they have invested a lot
of capital, they should have an opportunity to price that product
based on what the market will bear, Gottlieb said.
"They're going to have a monopoly, but that monopoly shouldn't last
forever," he said. "That's what we're trying to facilitate."
Gottlieb said his sense is that some companies are seeing less of an
economic prerogative to be the third or fourth to market.
"The days of being the 12th statin are over," he said. "You
literally see companies pulling out if they think they are going to
be fourth and fifth drug on the market. Companies aren't chasing
those opportunities."
He believes that over the past 10 to 15 years the time to market for
the second drug in a new class has gotten longer. The agency is
currently undertaking an analysis to see if that thesis is correct,
and look for ways to accelerate those approvals.
VERY COMPETITIVE
Some cancer drug executives interviewed at the ASCO meeting,
however, disagreed with Gottlieb's theory.
"I would love to ask him to give me an example of that," said Liz
Barrett, former global president of oncology at Pfizer Inc, who now
heads up Novartis' cancer operations.
"If you think about the evolution of oncology in the past few years,
it's very competitive in each class," she said.
"I think we're in an era where we make the assumption that there's
going to be competition. Even if you get breakthrough therapy
designation, that doesn't stop another medicine in the same class
from getting breakthrough therapy," Barrett said.
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Roy Baynes, head of global clinical development at Merck & Co does
not see a need for the FDA to change the way it does business.
"If you have got good data, there is no barrier to getting
approved," he said. "It is in everyone's interest to get medicines
as quickly as possible."
But when it comes to new prescription drugs, competition does not
always bring down prices. It often takes intervention from health
insurers and pharmacy benefit managers to really move the needle.
The introduction of rivals to Gilead Sciences' first-to-market
hepatitis C cure from AbbVie and others almost immediately drove
down prices. But the cost of hot new cancer immunotherapies have
remained high despite intense competition.
A pair of potent but expensive cholesterol treatments from a new
class - one sold by Amgen Inc <AMGN.O> and the other by Regeneron
Pharmaceuticals <REGN.O> with partner Sanofi <SASY.PA> - won U.S.
approval within a month of each other in 2015. But insurers refused
to pay for them in most cases until companies agreed to slash
prices.
Sean Bohen, chief medical officer at AstraZeneca, said there may be
a bit of a lag in competition in cancer drugs, but not for many
other drug classes.
In the case of TNF inhibitors for rheumatoid arthritis and other
autoimmune diseases, he said AbbVie's Humira is "the biggest by far,
and it was the third approved in the class."
Bohen agreed that companies do need expeditious reviews. But he said
the FDA has been proactive at bringing new treatments to market.
Astra's immunotherapy Imfinzi was not first in the class, Bohen
said, "but I didn't feel like we were treated like 'Oh, we've got
one of those already.'"
If there is any issue, he said, it's a resource issue.
(This version of the story corrects spelling to Bohen from Bohan,
paragraph 20 and throughout)
(Reporting by Julie Steenhuysen and Deena Beasley; Editing by Bill
Berkrot)
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