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FDA ups fight against fake drugs

/ Source: The Associated Press

Anti-tampering technology alone won’t solve the growing problem of counterfeit drugs, the government says as it looks for options to tighten the security of medicines on their way from factory to drugstore.

The Food and Drug Administration is considering making manufacturers ship pills in smaller quantities. Eventually, high-tech gadgets such as hidden transmitters or chemical tags will help assure pharmacists the medications are genuine.

It will take multiple strategies because criminals can crack and copy many anti-tampering measures, such as holograms on packaging, in just a year or two, says the first report, released Thursday, of the FDA’s new counterfeit task force.

The FDA wants more states to follow Florida’s lead in tightening licensing and other requirements for drug wholesalers and distributors, to plug gaps where counterfeits can sneak into the drug supply.

“This is where the dollars are, this is where organized crime is being attracted,” FDA Commissioner Mark McClellan said, adding that narcotics traffickers now see faking prescription drugs as an easy sideline.

“We know the drugs available in the United States today are among the safest in the world,” he said. “To keep it that way, we need to remain on guard.”

When drugs are bought from a regular licensed pharmacy, the chances of getting a counterfeit are less than 1 percent, McClellan estimated.

But buying drugs over the Internet can increase the risk, and counterfeits are sneaking into regular drugstores more often. The FDA has investigated about 20 counterfeit cases a year since 2000, compared with five a year in the 1990s.

One of the biggest cases came last spring, when more than 150,000 bottles of the cholesterol medicine Lipitor were recalled. Consumers complaining of a bitter taste alerted the FDA that knockoffs from overseas were mixed into the real version.

The report outlines options that the FDA wants the public as well as drug makers and sellers to comment on before final recommendations are issued in January.

Atop the options list is a recommendation to make drug companies start shipping in smaller “unit of use” sizes - say 30 pills in a blister pack instead of hundreds per shipment that smaller distributors then rebottle.

Smaller sizes can make it harder to sneak in fakes and could mean an end to companies that repackage or rebottle large shipments into patient-sized bottles.

Europe has adopted that system, but only 20 percent of the U.S. drug supply is shipped as unit-of-use. The pharmaceutical industry has mixed feelings, and McClellan said he wants more information on whether the approach would save money.

Among the other options are:

  • Requiring tamper-evident packaging for all drugs.
  • Requiring drug packages to bear anti-counterfeiting technologies, such as hidden transmitters that pharmacists can scan to be sure they did not buy a fake drug.
  • Requiring the drugs most prone to counterfeiting to be closely tracked by limiting the number of times they are sold in the supply chain.

The FDA in 1999 postponed rules that would have required a paper trail to validate every sale between drug makers and distributors. Critics say bringing back that “paper pedigree” would be a good interim solution.

Some drug companies already hit by counterfeiters are not waiting for FDA action.

Bayer Biological Products this month begins selling Gamunex, an injection to bolster weak immune systems, with logo-embossed shrink-wrapping over every individual vial. It is the first in a more tamper-resistant product line.

The company last year required every wholesaler it does business with to go through quality-assurance training before signing a contract forbidding any unauthorized resale.

More than 100 wholesalers once resold Bayer Biological’s products, but just 21 won the right to under those new contracts, said vice president Joel Abelson.

“The solutions are there. It’s having the will,” he said.