FDA Tackles Counterfeit Drugs

Counterfeit Drugs

To combat the growing problem of counterfeit drugs, the government is searching for ways to tighten the security of medications and to make them more tamper-proof as they travel from factories to drugstores.

The FDA is considering asking manufacturers to ship tablets in smaller quantities (e.g., 30 pills in a blister pack instead of hundreds per shipment); smaller distributors would then rebottle them. Smaller sizes can make it more difficult for counterfeiters to sneak in fakes, although this step might put an end to companies that repackage or rebottle large shipments into the smaller bottles that patients receive.

When drugs are bought from a regular licensed pharmacy, the chances of receiving a counterfeit drug are less than 1%, but buying drugs over the Internet can increase the risk. Counterfeit products are also showing up in drugstores more often. The FDA has investigated about 20 counterfeit cases per year since 2000, compared with five per year in the 1990s.

Earlier this year, more than 150,000 bottles of the cholesterol medication atorvastin (Generic Lipitor®, Pfizer) were recalled after consumers complained of a bitter taste. “Knockoffs” from overseas had been mixed into the authentic version.

The following options are also being considered:

  • Using tamper-evident packaging on all drugs.
  • Using packages that bear anti-coun-terfeiting technologies, such as hidden transmitters that pharmacists can scan, to be sure they have not bought a fake drug.
  • Closely tracking the drugs that are most likely to be counterfeited by limiting the number of times they are sold in the supply chain.

In 1999, the FDA postponed enforcing rules that would have required a paper trail to validate every sale between drug makers and distributors. Critics recommend bringing back that paper system as a temporary solution.

Some drug companies are not waiting for FDA action. Bayer Biological Products, for example, will begin selling intravenous immune globulin (Gamunex®) with logo-embossed shrink-wrapping over each vial.

For more information on the FDA’s evolving role in improving safety, see the articles on pages 698 and 719 in this issue.