With
both the House and Senate refusing to be the first to flinch in their ongoing
game of chicken Tuesday, the rest of America was getting a feel for how the
first government shutdown in 17 years might affect their day-to-day businesses.
For
biopharma, the impact will depend on how long it takes Congress to agree on a
continuing resolution to fund government agencies in lieu of a fiscal 2014
budget. The last shutdown of nonessential government programs lasted more than
three weeks, from Dec. 16, 1995, to Jan. 6, 1996.
Unless
a drugmaker has an upcoming PDUFA date or a meeting scheduled with the FDA,
chances are the impact would be minimal – at least in the short term. While the
agency’s contingency plan calls for 55 percent of the FDA staff to continue
working through the shutdown, it’s hard to say how things would play out if the
government were to remain closed for an extended period of time.
“Since
the underlying activities and staff are paid for by a combination of user fees
and appropriated funds, it is too early to predict the priorities and
achievable workload of the retained staff,” according to the Alliance for a
Stronger FDA.
By
law, the FDA may continue activities funded by user fees and carryover money.
But user fees cover only two-thirds of the agency’s drug review activities,
Steven Grossman, deputy executive director for the alliance, told BioWorld Today. That split
in funding means the FDA won’t be able to do everything it has in the past.
“They’re
going to have to triage,” Grossman said of the FDA staff working through the
shutdown. “They’re going to have to figure out what their priorities are” and
then determine what can be accomplished with the reduced work force.
How
those decisions affect advisory committees, user fee deadlines and various
other product-critical, nonsafety functions remain to be seen, he added.
Adcoms on Tap
A
few drug advisory committee meetings are scheduled this month. The
Endocrinologic and Metabolic Drugs Advisory Committee is first in line with an
Oct. 16 meeting set to discuss another indication for Amarin Pharmaceuticals
Ireland Ltd.’s Vascepa (icosapent ethyl) tablets.
The
Anti-Infective Drugs Advisory Committee is scheduled to meet Oct. 18 to
consider Paladin Therapeutics Inc.’s new drug application (NDA) for miltefosine
tablets to treat visceral, mucosal and cutaneous leishmaniasis. The day before
that meeting, the adcom is slated to discuss susceptibility interpretive
criteria for systemic antibacterial drugs and for dosing recommendations in
labeling.
Later
in the month, the Antiviral Drugs Advisory Committee is supposed to have a
two-day meeting in which it will consider NDAs for hepatitis C drugs sponsored
by Janssen Pharmaceutical Co. and Gilead Sciences Inc.
The
FDA has yet to indicate whether the adcom meetings will be affected by the
shutdown.
PTO, SEC Remain Open
The
situation isn’t as iffy with some of the other government agencies that
typically interact with biopharma. For instance, the shutdown isn’t likely to
get in the way of filing and processing patents, as it will be business as
usual at the Patent and Trademark Office (PTO). Funded by user fees, the PTO
said it has sufficient prior year reserve fee collections to operate for about
four weeks.
However,
if Congress has yet to pass a spending bill by the time those funds run out,
the PTO would have to close its doors. Should that happen, “a very small staff
would continue to work to accept new applications and maintain IT
infrastructure, among other functions,” according to the office.
Another
agency that doesn’t intend to shut down any time soon is the SEC, which also
receives fees. Last week, the SEC said it planned to remain open and
operational in the event of a lapse in government appropriations. At the same
time, it released a contingency plan, just in case.
Under
that plan, about 250 employees – about 6 percent of the SEC’s work force of
nearly 4, 150 – would remain on the job if the commission were to shutter its
offices. The SEC would continue some law enforcement and monitoring activities,
and its filing systems, including EDGAR, would remain functional.
However,
should it shut down, the SEC would discontinue the processing and approvals of
filings and registrations and of self-regulatory organization rule changes. It
also would stop all nonemergency rulemaking.
While
no one is venturing a guess as to how long the shutdown will continue, White
House Press Secretary Jay Carney discussed speculation Tuesday that the
standoff over the continuing resolution could be rolled into action on the debt
ceiling. The Congressional Budget Office expects the Treasury Department will
exceed its borrowing authority between Oct. 22 and the end of the month. Once
that happens, it will take an act of Congress to raise the ceiling.
For
now, biopharma is taking a wait-and-see attitude on the shutdown. Given the
vital role federal agencies play in drug R&D, “we cannot speculate on the
full impact of a government shutdown on the biopharmaceutical sector,” said
Matthew Bennett, senior vice president of Pharmaceutical Research and
Manufacturers of America (PhRMA).
Meanwhile,
“PhRMA will work with the agencies and the administration in an effort to
minimize any negative consequences a shutdown could have on patient health and
access to medicines,” Bennett told BioWorld
Today.
Fuente:
BioWorld, Thomson Reuters
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