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 Hurricane Maria slammed into the Caribbean island on Sept. 20,
knocking out electricity and causing widespread damage to homes and
infrastructure. Almost three weeks later, just 16 percent of
electricity service has been restored to the U.S. territory.
Drugmakers are working to get facilities fully online, but face an
uncertain power supply and difficulty obtaining materials used in
the manufacturing process.
"A lot of companies say they're online, but they basically have one
of five lines running at 20 percent or 80 percent or 50 percent,"
FDA Commissioner Scott Gottlieb told Reuters in an interview in New
York. "They are not manufacturing at full capacity. They are
manufacturing well short of that."
"It's unclear when they are going to be able to bring that up to
full capacity," he said.
Asked when U.S. hospitals and pharmacies might see shortages as a
result, he said: "You might see some in the next two or three weeks
if there's going to be additional shortages coming out of this
situation."
The FDA has warned of 40 drugs made in Puerto Rico that could face
shortages, including treatments for cancer, rheumatoid arthritis and
HIV, but has not named specific medicines.
Most major drug companies have manufacturing facilities on the
island, including Merck & Co, Johnson and Johnson, Amgen Inc,
Bristol-Myers Squibb Co, Eli Lilly and Co, Pfizer Inc, AstraZeneca
and GSK
The FDA leader said he wants drugmakers to provide the public with
more information about the extent of the problems they are facing.
He said the plants were all relying on backup generators for
electricity, some of which were not designed to operate for
sustained periods of time.
"I'm going to ask some of these companies to be a little more
transparent around some of these issues," he said, adding that
improvements would likely come slowly, with potential setbacks along
the way. "As time goes on, we're going to see secondary impacts like
the generators could start going down."
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Gottlieb said he was "troubleshooting for individual companies" on a
daily basis and working with the U.S. Federal Emergency Management
Agency and the Department of Homeland Security to address issues
such a fuel shortages and shipping problems that could stall
operations.
Most of the companies contacted by Reuters said they are working to
avoid product shortages.
Bristol-Myers said it has resumed limited operations to ship
warehoused products. "As of today, no product supply impact is
expected, however we continue to assess the challenging operational
conditions on the island," spokesman Ken Dominski said.
Amgen, in a statement, said it was "preparing to resume
manufacturing in various plants over the next several weeks" and did
not anticipate an impact on supply to patients.
Merck has one manufacturing facility on the island. "We have brought
power back online via on-site generators that will allow most
operations to proceed," spokeswoman Claire Gillespie said.
Of the list of drugs being closely monitored by FDA, 14 medicines
are sourced solely out of Puerto Rico, Gottlieb said.
He said the agency was working with drugmakers and would consider
approving manufacturing sites in other countries, such as Mexico,
Canada or Ireland, to alleviate possible shortages if companies have
plants there.
(Additional reporting by Caroline Humer and Michael Erman in New
York and Toni Clarke in Washington; Editing by Michele Gershberg and
Bill Rigby)
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