FDA Outlines Options to Fight Counterfeit Drugs

In an effort to prevent counterfeit medicines from entering the marketplace, FDA officials are considering having manufacturers package drugs in individually sealed doses, as well promoting other solutions to counter the problem.

Emphasizing that there is no single ?magic bullet? solution, the agency issued a 40-page interim report last month outlining some of the risks to the nation?s drug supply. The agency plans to issue a final report, with recommendations, early next year. ?We have just about the world?s safest and best drug supply. To keep it that way, we have to remain on guard,? said FDA Commissioner Mark McClellan, MD, PhD.

In the report, the agency suggests tagging bottles of pills with radio-frequency chips that could let pharmacists automatically determine the source of each bottle. Officials also see the need for tougher oversight of distributors and better-informed consumers. Another suggestion is to ship drugs in individually sealed packs filled with the amount needed for a typical prescription. This measure would eliminate 1 entry point for problem drugs - repackaging - where large boxes of pills are broken into smaller units or into individual amber bottles that patients receive.

There are some challenges with this last option, including making so-called blister packs childproof, while still being accessible to the elderly. Also, the Pharmaceutical Research and Manufacturers of America claims that this idea may be impractical for some drugs. ?If you look at most antibiotics, there are all kinds of variable dosage regimens,? said Alan Goldhammer of the trade association. ?Some could be used for 7 days or 14 days or 21 days.?

Until the FDA issues actual recommendations, pharmacists and patients need to be aware of the possibility of counterfeit medicines. Patients should immediately report anything suspicious about a drug to their pharmacist, who then must immediately alert the drug?s maker and the FDA, said FDA pharmacy chief Tom McGinnis.