Next-to-nothing inspections as 80% of ingredients in drugs imported; 40% of all drugs imported

Foreign suppliers of drugs escaping FDA scrutiny
WASHINGTON, D.C.
Wednesday, October 31, 2007 14:41 MDT

Government inspectors visit the foreign companies that make more and more of
the drugs used in the United States just once every 8 to 12 years on
average, according to congressional investigators.

That's far less oversight than domestic producers face.

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, the inspectors said in a memo to members of the
House Energy and Commerce subcommittee on oversight and investigations The
memo was released Wednesday.

The FDA plans to inspect just 300 of those thousands of 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.

Federal law requires the roughly 3,300 domestic drug manufacturers to be
inspected, often unannounced, once every 2 years - something the FDA does
come close to doing. There is no such legal requirement for foreign makers.

"Given the potential risk from foreign sources, this places an unacceptable
risk on the public," said Rep. John Dingell, D-Mich., the committee's
chairman.

That discrepancy, along with other issues surrounding the FDA's ability to
monitor the safety and purity of imported drugs, will be the subject of a
congressional hearing Thursday. Some manufacturers are already crying foul.

"If you're not being inspected, is there really a regulatory scheme at all?
Foreign manufacturers are able to not have to worry about inspections and
perhaps not follow the rules as they're supposed to - and domestic
manufacturers want to play by the rules, have to play by the rules and are
inspected to the rules," said Gregory Minchak, a spokesman for the Synthetic
Organic Chemical Manufacturers Association, a trade group that has set up a
task force to represent U.S. makers of active pharmaceutical ingredients. It
estimates foreign manufactures are visited even less frequently, just once
every 14 years on average.

An estimated 80% of the active pharmaceutical ingredients used to make drugs
sold in the U.S. are imported. Among finished drugs, an estimated 40% are
made abroad.

The FDA's serious problems in its ability to adequately police those imports
have been known for years - the FDA itself noted as much in an internal
report in 1988, and as did the Government Accountability Office (then known
as the General Accounting Office) a decade later.

FDA spokeswoman Julie Zawisza said the agency uses a risk-based approach to
inspecting both domestic and foreign manufacturers, "with focus on those
whose products could pose potential risk to consumers."

But congressional investigators say little over the last 2 decades has
changed, except the FDA now devotes even fewer people and dollars to foreign
inspections. The number of employees dedicated to the foreign inspection
program is expected to fall to 102 by 2008, down from 149 in 2002. And next
year, the program budget should be just shy of $16 million, or less than the
$16.7 million spent in 2002, they found.

"They are in an indefensible position from a public health point of view but
they have no real choice," said former FDA associate commissioner William
Hubbard, citing the budgetary constraints faced by the agency. Hubbard has
agitated for more money and inspectors at the agency and is among those
expected to testify Thursday. Better technology also is needed, Hubbard
said.

Congressional investigators, for example, report that the FDA maintains
distinct databases covering imported drugs and their manufacturers. The
import data contain largely invoice information and don't reflect how an
imported drug was made, processed, packed or distributed.

"FDA has different and incompatible databases for tracking what drugs and
drug ingredients are imported into the United States, what companies are
certified to import drugs into the United States and which foreign drug
producing firms have been inspected by the FDA," said Rep. Bart Stupak,
D-Mich., chairman of the subcommittee holding Thursday's hearing.

Stupak said that system leaves the FDA unable to answer even basic questions
about the source of foreign drug imports.