FDA intensifies attack on fake drugs

A multifaceted plan to stop counterfeits is beginning to take shape.

By Susan J. Landers, amednews staff. Oct. 27, 2003.

Washington -- Digital watermarks, fluorescent tracers, scent markers, bar codes. They sound like spies' tools of the trade. But these are some of the possibilities the Food and Drug Administration is exploring to thwart a recent increase in counterfeit medications infiltrated into the nation's prescription drug distribution system.

An interim report from the FDA's Anti-Counterfeiting Task Force released in early October indicates that not much is off limits in the quest to quell this mounting public health threat.

Chinks in the armor
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"The FDA's task force is developing innovative approaches as never before on the significant and growing problem of counterfeit drugs," said FDA Commissioner Mark B. McClellan, MD, PhD.

The report covers protective technology, devices that track pills from manufacturer to pharmacy and new regulatory requirements to limit the opportunities for tampering along the way.

From the late 1990s until 2000, the FDA typically investigated between four and six counterfeit drug cases a year. But in 2002, the number rose to 22. So far this year thousands of bottles of fake Lipitor were recalled, and patients were found to be injecting bogus versions of the anemia drugs Procrit and Epogen and fake Neupogen. Although no deaths have been directly attributed to the impostor medications, the fakes pose a decided risk to patients.

This uptick in counterfeits has prompted the FDA to fight back, and the task force report is the agency's first draft of a comprehensive plan to attack the issue. An Oct. 15 public meeting was also scheduled to discuss issues surrounding the FDA efforts, with written and electronic comments and suggestions accepted until Nov. 3.

The FDA has investigated 22 cases of counterfeit drugs this year, up from the usual 4 to 6.

Concluding that there is no single "magic bullet" that will likely thwart the growing number of sophisticated counterfeiters, the task force instead recommended a multipronged strategy that could prove more effective.

In addition to technology and regulations, the report explores the use of a rapid alert system, education and public awareness, and international collaboration to help rein in the threat. The problem's growth is attributed, in part, to the realization among the criminal element that a lot of money can be made in fake drugs and that, if they are caught, the penalties are generally mild.

Pharmaceutical manufacturers and distributors have pledged their support for many of the FDA's ideas, and some have launched their own safeguard attempts.

"The industry is already pursuing quite a few of the FDA's recommendations," said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, which represents many large drugmakers.

PhRMA favors the enforcement of a rule, on hold for many years, that requires drugs to have pedigrees -- paper trails that document their route through the system. This would make it easier to detect any unauthorized diversion. The FDA report noted that drugs can follow a very circuitous path through the nation's distribution system, with several wholesalers and retailers handling the products before they reach consumers.

Drug firms are also developing special packaging designs and are investigating the use of special inks and holograms, Trewhitt noted.

Overseeing foreign drugs imported via the Internet is outside the FDA's regulatory scope.

The Healthcare Distribution Management Assn., whose members represent more than 90% of the nation's pharmaceutical distributors, recently adopted a new, voluntary program to help keep counterfeits out of the marketplace. HDMA, which has opposed the pedigree rule, is urging distributors to carefully check the licenses and other documentation held by those they purchase drugs from to be sure that they are on the up-and-up.

The distributors also pledged to notify the FDA and the manufacturer within five days of the discovery of a suspicious product.

U.S. Pharmacopeia, an independent monitor of medication quality, urges that suspicious drugs be compared with published standards, or monographs, to winnow out the fakes.

The FDA stressed that the report on counterfeits is not intended to address the issue of drugs being imported via the Internet from abroad. Those products are beyond the regulatory scope of the agency and fall into the category of caveat emptor, said the task force. However, many counterfeits do come from other countries, thus making an international cooperative effort important for success. The task force suggested strengthening international law enforcement efforts and developing global standards for drug packaging.

Despite the counterfeits, drugs available in the United States are among the safest in the world, said Health and Human Services Secretary Tommy Thompson. "But we must still be on our guard against those who would exploit patients by selling counterfeit drugs instead."

The task force's final report is due in January 2004.

ADDITIONAL INFORMATION:

Chinks in the armor

The Food and Drug Administration has identified several areas of vulnerability in the nation's prescription drug distribution system:

Incomplete pedigrees Confidence in drug authenticity is diminished without a statement of origin that traces the product from its point of manufacture to the consumer.

Inadequate authentication Purchasers in the distribution chain do not always ensure that the products they buy are the genuine articles.

Repackaging This practice can destroy anticounterfeiting measures used in original packaging and labeling of the drug and may provide an entry point for expired, adulterated or counterfeit drugs.

Inadequate packaging Many products do not have tamper-evident features.

Importation A portal of entry for counterfeit drugs is created when consumers order medications from other countries.