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 The market for piperacillin-tazobactam is highly concentrated with
Fresenius and Chinese rival Qilu supplying almost the entire
European market between them. Production outages at Qilu have
already caused repeated stock shortages over the past three years.
The European Medicines Agency is working on a revision of good
manufacturing practices (GMP) that govern the production of sterile
drugs such as infusions and injections to take into account the
latest technology developments.
Fresenius said that under the draft proposals, the
bulk-freeze-dryers that is uses to produce the antibiotic would have
to be sterilized more frequently, providing no additional safety
benefits but slashing output capacity by 40-45%.
"We have formally lodged our concerns, and we have suggested
solutions. But in our dialogue with EMA and other bodies involved we
haven't had the impression that our message came across, yet," said
Marc-Alexander Mahl, in charge of generic drugs and complex
formulations at the Kabi division of Fresenius.
Though EMA was "a great regulatory body" and the GMP review an
important initiative overall, piperacillin shortages should be
avoided because second-choice drugs would put patients' lives at
risk from avoidable infections, he argued.
Piperacillin, given in combination with efficiency-booster
tazobactam, is a broad-spectrum antibiotic used to combat serious
infections such as sepsis or pneumonia.
The company cited a study as showing that lack of piperacillin could
result in more than 2,000 additional deaths per year from serious
infections in Europe as doctors resort to less effective
alternatives.
The non-profit Access to Medicine Foundation (AMF) warned in a
report
https://accesstomedicinefoundation.org/
news/access-to-medicine-foundation-
makes-case-for-fixing-the-
antibiotic-market last year of an emerging crisis in the global
anti-infectives market, with piperacillin particularly exposed, as
fragile drug supply chains were relying on just a few big suppliers.
LONG PROCESS
Fresenius said that upgrading its production lines would take about
five years, longer than a transition period of six months to two
years typically granted after regulatory change.
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A spokeswomen for EMA said the regulator had consulted widely with
the industry.
"It may be that the next version of the document will have some
changes in the text from the version that was published for
consultation," she added.
The EMA's working group of GMP inspectors will discuss the review
and industry concerns this week, with publication of the final
version not expected before early next year, she said.
"It is important to have high standards and companies around the
world need to keep investing in their plants," the Access to
Medicine Foundation's Executive Director Jayasree Iyer told Reuters.
"But the risks are clear especially in a market where a lot of
manufacturers are disincentivized to stay on board and there's more
and more dependency on fewer manufacturers."
Rule changes in Europe could have considerable knock-on effects in
developing countries and exacerbate drug shortages there, she added.
When piperacillin is lacking, physicians typically give antibiotics
with a narrower spectrum, running the risk of sparing some harmful
bacteria and possibly triggering resistant germs.
Most antibiotics are cheap, off-patent generic medicines, offering
low profit margins compared to modern patent-protected drugs for
diseases like cancer - offering manufacturers little incentive to
invest in new production facilities.
(Reporting by Ludwig Burger; Editing by Keith Weir)
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