Export officials estimate that 20 million packages containing pharmaceuticals come into the United States each year — and
14% have something wrong with them. The rise in Internet pharmacies is spurring the import trend, as are higher prices of
drugs and biotech therapies in the United States.
This surge in imported prescription therapies is raising concern at FDA and among manufacturers that the door is opening to
a flood of counterfeit and unapproved drugs and biologics. Ironically, members of Congress could make it easier for counterfeit
drugs to enter the United States by pressing for legislation that would enable individuals and pharmacists to reimport lower-cost
drugs from abroad. Advocates aim to increase consumer access to less expensive medicines, despite protests from FDA and industry
that the policy is unwise and unworkable. Meanwhile, manufacturers are examining how new technologies can prevent product
tampering and identify counterfeits, while backing policies to protect product names and patient safety.
Attack on Counterfeits
As counterfeit cases piled up in recent months, FDA launched a more aggressive program to halt the influx of bogus drugs from
abroad (see www.fda.gov/oc/initiatives/counterfeit). The agency established an internal task force in July to explore the use of new technologies and identify enforcement actions
that could stymie distribution of counterfeit medical products. The panel — led by John Taylor, associate commissioner for
regulatory affairs, and Bill Hubbard, associate commissioner for policy and planning — is scheduled to report recommendations
this month.
The initiative stems from evidence of rising counterfeit pharmaceutical distribution in the U.S. FDA opened 22 counterfeit
drug cases in 2002 and 20 cases in 2001 — big jumps from about 5 to 6 cases each year previously. Since 1996, FDA counterfeiting
investigation cases have led to 44 arrests and 27 convictions. Most cases involved high-cost injectables and high-volume drugs,
such as statins, AIDS therapies, and antidepressants. One report speculates that unscrupulous distributors are diverting to
the United States some low-cost and free drugs intended for foreign medical aid programs.
FDA has issued warnings that counterfeit versions of Procrit (epoetin) from Ortho Biotech and Amgen contain nonsterile tap
water that could cause infections. Last year, counterfeiters substituted insulin for Eli Lilly’s injectable drug Zyprexa (olanzapine).
A counterfeit version of Serono’s AIDS treatment Serostim (somatropin) had no active ingredient at all. Pfizer recently warned
pharmacists of widespread distribution of unauthorized Lipitor (atorvastatin) that patients found to have a bitter taste.
This rise in counterfeit biologicals is of particular concern because therapeutic proteins manufactured from living cells
are more susceptible to contamination, said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), in
a letter to FDA last February (see www.bio.org/reg/impltr.asp).
Seeking Deterrents
The Prescription Drug Marketing Act (PDMA) of 1988 provides FDA with authority to track illegal drug distribution in the U.S.
It requires wholesalers to keep paper records of a drug’s source and distribution history to provide a "pedigree" for prescription
products. However, the tracking requirements are expensive, and FDA has failed to finalize regulations implementing PDMA due
to objections from wholesalers. Now the surge in counterfeit products is putting pressure on FDA to implement the tracking
program, although new authentication approaches could necessitate updating the 1988 policy.
The need for legislation to strengthen PDMA will be addressed by FDA's counterfeit drugs task force, which is examining new
technologies capable of assuring product integrity. Most anticounterfeit efforts involve identifying look-alike packaging
that can fool health professionals as well as consumers. Because phony medicines can be put in highly authentic-looking packages,
manufacturers and regulators also are examining ways to incorporate authentication substances (such as chemical taggants)
into finished products.
In addition, FDA is working with U.S. Customs offices to identify what counterfeits are arriving from foreign countries. The
agency also is collaborating with states such as Florida (which has adopted stronger drug wholesaler licensing requirements)
that may provide a model approach for other states. And while battling counterfeits at home, FDA officials are working with
manufacturers and foreign governments to stem widespread, bogus drug marketing in both developing and developed countries.
FDA notes that Chinese counterfeiting of some drugs may be as high as 50%, while estimates are around 40% for fake pharmaceuticals
in Argentina, Colombia, and Mexico.
