[Ip-health] News: FDA urged to certify medicines more quickly
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Thu May 12 03:44:08 PDT 2011
FDA urged to certify medicines more quickly
Health activists have urged the Food and Drug Administration to speed up
certification of drugs for fighting Aids.
About 100 patients representing a network of Aids, cancer, kidney disease
and mental health patients yesterday rallied at the agency asking for
clarification from FDA executives.
The group said drug approvals by the agency were moving too slowly, which
was holding back access to life-saving medicines.
They had checked with the Government Pharmaceutical Organisation (GPO) about
three generic regimens, Efavirenz, Tenofovir and GPO-VIR S7, and found
essential scientific documents needed for FDA approval had been submitted
"This is a matter of life and death for thousands of us, particularly
children," she said.
Normally, the FDA spends up to 110 days examining documents, shortened to 70
days for fast-track examinations needed as part of the approval process.
However, the approval process for GPO-VIR S7 for HIV-positive children had
so far taken years, and still there were no results, said Supatra Nakapew,
from the Thai NGO Coalition on Aids.
The group asked how many generic drugs were still pending approval, and
whether a certain person hired to check documents for approval might have a
conflict of interest with drug companies.
FDA secretary-general Pipat Yingseree said the agency could not certify any
drug unless essential scientific documents were sent to support the regimen.
In some cases, the documents sent to support the safety of the drugs were
But Dr Pipat said he would ask if a retired FDA official who checks
documents as part of the certification process really had a conflict of
interest as claimed.
Meanwhile, the Thai Network of People Living with HIV/Aids says more action
is needed to stop drug companies renewing patents on life-saving drugs on
It has sought an assurance from the Commerce Ministry that so-called
"evergreen" patents on medicines will be banned, says network president
He asked Yanyong Phuangrach, the ministry's permanent secretary who is also
chairman of the Patent Committee, to ensure that patents are not renewed in
perpetuity if the drug companies owning the patent have not added anything
new to medicines.
When patents expire, manufacturers can make cheap copies, called generics.
Mr Aphiwat said drug manufacturers which seek an extension to their patents
often claim to have added some new ingredients or developed the original
drug further, which enables them to secure an extension, blocking rival
manufacturers from making cheaper versions.
Mr Aphiwat said some multinational pharmaceutical firms adjust only a little
of the drug formula and apply for new patent protection for another 20
years, creating obstacles for the development of cheaper medicines.
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