New drug ingredients to fight counterfeiting

Just as the U.S. Mint redesigned currency to foil counterfeiters, the FDA is advising drugmakers on how to redesign their pills. The agency issued a draft guidance on special ingredients that would make it easier to authenticate tablets and capsules. "Drug counterfeiting is a serious public health concern," Commissioner Margaret Hamburg (photo [1]) said in a statement. "We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients."

Apparently the guidance is a response to the industry's casting about for anti-counterfeiting strategies. The PCIDs under discussion--physical chemical identifiers--are substances that either via pigment, flavor, or molecular tag can brand a product as legit. The FDA said it "anticipates" that many of the potentical PCIDs are already in use as food additives, or that they're "other types of inactive ingredients with established safety profiles."

Drug counterfeiting is a growing concern worldwide. Just yesterday, a group of U.K. businessmen that were trying to sell fake meds on an "industrial" scale were sentenced to more than 17 years. They were part of a global ring, investigators said, with operations in China, India, Pakistan, the Caribbean and the U.S. Ghana has been combating fake malaria drugs, and the U.K. government recently warned citizens about counterfeit Tamiflu. So there's plenty of incentive for drugmakers [2] to somehow tag their meds as authentic.

- read the guidance [3] from FDA (pdf)
- see the FDA release [4]
- check out the sentencing news [5] from Staff Nurse

Related Articles:
Drug fakers see opportunity in flu [6]
EU wholesalers concerned about packaging [7]
EU officials seize 34M counterfeit medicines [8]
Savvy marketing boosts fake pharmacies [9]
Drug theft costs pharma $71B yearly [2] (Oct 2007)