HI Friends, I thought you might want to take note of this. Hopefully they will get this situation straightened out.
Thanks, Carla :)
WASHINGTON - The Food and Drug Administration
isn't paying enough attention to inspecting the growing amount of drugs
produced by foreign manufacturers, say lawmakers who want the agency to
update its approach. The
head of the FDA is being called before a congressional committee
Thursday to explain his agency's lopsided approach to inspecting drugs,
both domestically and overseas.
Members of the House Energy and Commerce subcommittee on oversight
and investigations say the FDA's overwhelming emphasis on domestic
inspections places the public at risk, as more and more drugs come from
overseas.
While nearly all U.S. drug makers are inspected at least once every
two years, foreign manufacturers can go eight or more years between
inspections, according to congressional investigators. While the
domestic inspections are mandated by a law drawn up long before imports
seized a sizable chunk of the drug market, there is no such requirement
that the FDA conduct foreign inspections with any regularity.
Prescription drugs and drug ingredients pour into the United States
from an estimated 3,000 foreign companies, though the real number is
unknown and could be as high as 6,700, congressional inspectors said in
a memo to members of the subcommittee ahead of Thursday's hearing.
Among those invited to testify: FDA commissioner Dr. Andrew von
Eschenbach. The agency declined an interview request ahead of the
hearing.
The FDA plans to inspect just 300 foreign drug firms this year,
announcing in advance its intent to do so each time. Of those
inspections, most are of plants that make drugs awaiting FDA approval.
Just 15 are of the type of periodic assessment meant to ensure a
company's products remain safe in the years following FDA approval,
though some pre-approval inspections also include some post-approval
surveillance.
In contrast, the FDA comes close to inspecting the roughly 3,300 domestic drug manufacturers once every two years as required.
An estimated 80 percent of the active pharmaceutical ingredients
used to make drugs sold in the U.S. are imported. Among finished drugs,
an estimated 40 percent are made abroad.
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Glad to make your acquaintance! Carla Carey
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