The pharmaceutical industry should find innovative ways to keep the nation’s drug supply secure, the head of the Food and Drug Administration said Wednesday, calling counterfeit medicine a health threat.
While the supply of prescription drugs in the United States is the safest in the world, FDA Commissioner Mark McClellan said there has been an increase in counterfeiting in recent years and criminals have become more sophisticated.
“This is a real public health threat,” McClellan said at a meeting of drug makers, distributors, pharmacists and federal regulators.
Some counterfeits are subpotent or contain no drugs at all, others are the wrong drug and some are even superpotent, he said.
With counterfeiters becoming more clever, companies and the government need to constantly review and update measures to protect the drug supply.
McClellan toured a trade show displaying technologies aimed at preventing the sale of counterfeit drugs. Manufacturers showed off tiny bar codes that can be painted on pills, tamper-resistant packaging with hard-to-copy holograms and even minute DNA-encoded microchips.
McClellan stressed that the event was aimed at countering fake drugs, rather than addressing the contentious issue of imported medications.
Nonetheless, the two issues have become tangled as more Americans look to other countries for cheaper sources of medicine. Imported drugs, often ordered on the Internet, can be a source of counterfeits,
The FDA says it cannot guarantee the safety of imported products. Critics charge that the agency is trying to undermine congressional efforts to let people buy cheaper drugs.
The pharmaceutical industry has undertaken a major effort to block drug import legislation, spending $8.5 million on lobbying this year alone.
In his speech McClellan listed four steps to reduce fake drug sales:
- Manufacturers, wholesalers, distributors and pharmacists need to review and improve secure business practices.
- The FDA needs better ways to receive reports of counterfeit drugs and to alert the public to limit damage.
- Better education is needed for consumers, pharmacists and health care professionals to recognize fake drugs.
- Washington needs to work with foreign governments because counterfeit drugs are a global problem.
Possible ways to help defeat counterfeiters are requiring manufacturers to ship pills in smaller quantities, which makes it less profitable to substitute counterfeits, or using high-tech gadgets such as hidden transmitters or chemical tags to help assure pharmacists that medications are genuine.
The agency’s counterfeit drug task force is expected to make a final report in January, McClellan said.
The FDA has investigated about 20 counterfeit cases a year since 2000, compared with five a year in the 1990s, he said.
The FDA reported in September that of 1,153 imported drugs checked by FDA and Customs agents, 1,019 were found to be illegal. They included drugs that had been withdrawn from the U.S. market, animal drugs never approved for human use, counterfeit drugs, drugs with dangerous interactions, drugs with dangerous side effects and narcotics.