Lawmakers are committed to reauthorizing drug user fee agreements well before the present ones expire at the end of September, a House of Representatives committee hearing was told Wednesday.
But the process is complicated
by the advent of a new administration and its policy and budget
statements, while Congress discusses agreements that were hammered out
between the previous administration and the pharmaceutical industry.
Michael Burgess (R-TX), chairing a Health Subcommittee hearing on
prescription drug user fees, pledged he and his fellow lawmakers will
work to make sure the new agreements are in place so that the Food and
Drug Administration (FDA) reviewers will not be receiving pink slips 60 days
before the current
Drug user fees are collected from
the pharmaceutical and medical device manufacturing industries to pay
most of the cost of reviewing and approving new products. In place for
prescription drugs since 1992, after which bio-similars, medical
devices and generics were added, the agreements must be reauthorized by
Congress every five years. Separate hearings have been held on
biosimilars, generics and devices.
Jeff Allen, president of the
Friends of Cancer Research, said his take from the committee hearing was
that all the stake holders, including members of Congress, have agreed
the process has to be completed in a timely manner.
"I would say
that the new administration adds an extra step to the process compared
to the last five reauthorizations," Allen told Patient Daily following
his appearance before the committee. It has not happened before that a
new administration has taken over after agreements have to a large
degree been reached.
It is unclear whether President Donald Trump or
his pick as head of the FDA, Scott Gottlieb, want to involve themselves
in the process, and to what extent, Allen said.
"There is not enough
information," he added.
Trump's budget proposal states that
the FDA's budget will not be increased but that the administration
wants the user fees to double to $2 billion in 2018.
constrained budget environment, industries that benefit from FDA’s
approval can and should pay for their share,” the budget outline said.
administration also wants a “package of administrative actions designed
to achieve regulatory efficiency and speed the development of safe and
effective medical products."
These positions have left some "a
little on edge," as they wonder whether the administration
wants to do some things differently, Allen said.
He said that the idea
of speeding up the process of review and approval is not new to this
administration, but what often happens is that those incoming "come to
the realization that the FDA is not necessarily the barrier."
Further, much has been done to make the U.S. much faster than Europe, for example, when it comes to the speed of approval, Allen said. This includes
the fast tracking of promising new medications, or "breakthrough
therapies," introduced under the 2012 agreements and provisions in the
recently signed 21st Century Cures Act.
In briefings following
the budget announcement, the pharmaceutical industry stated the language
in the Department of Health and Human Services budget is limited and
ambiguous. It wants clarity to understand the potential impact on the
In a statement issued to Patient Daily following the
hearing, Pharmaceutical Research and Manufacturers of America (PhRMA)
president and CEO Stephen J. Ubl said the industry's position is that "user fees are an important mechanism to support the critical work"
of the FDA.
"Moving the Prescription Drug, Biosimilar and
Generic Drug User Fee Acts forward in a timely manner is important to
support FDA’s mission of protecting public health and promoting
innovation, to enhance the competitive market for treatments and to get
medicines to patients in need," Ubl said.
In testimony to the
committee, Anne Pritchett, PhRMA vice president of policy
and research, said the prescription drug agreement "supports common
sense reforms that provide greater predictability for the Agency."
reforms include reducing FDA’s administrative burden and operating
expenses for the PDUFA program without compromising the human drug
review program performance, regulatory review standards or patient
safety," Pritchett said.
Rep. Burgess said he and Energy and
Commerce Committee Chairman Rep. Greg Walden (R-OR) are committed to
shepherding the user fee agreement through committee and on to the floor
of the House. They want to do so well before the end of the current
The reauthorization process is "an opportunity to
examine and improve upon the state of discovery, development and
delivery of medical therapies in America," Burgess said in his opening
statement at the hearing.
He also cited as an example the 2012 reauthorization bill, which established the "breakthrough therapy" process.
added that he hoped the drug user fee program will complement the 21st
Century Cures Act, which includes provisions designed to help the FDA
streamline its work. He welcomed assurances given at the hearing from
the FDA's Dr. Janet Woodcock, who promised much greater patient input
into the process of approving medications.
"We are committed to
keeping the reauthorization process on track though we all know there
are competing influences this year," Burgess said. "It's widely agreed
that PDUFA will provide for a timely review of drugs and new biomedical
licence applications. That is a good thing."
Allen, the cancer
research advocate, said his main concern is not over the new
administration's policies, more the mechanics of pushing through the
needed legislation in a year when so much else is going on legislatively
with health and in so many other areas.
Lawmakers promise timely renewal of drug fee agreements