In wake of heparin deaths, a call for stickers
Do you know where your medication's been?
Bananas come with those little stickers listing their country of origin. Why not pharmaceuticals?
That's what some consumers -- and some physicians -- are asking since the Food and Drug Administration linked the deaths of as many as 62 people to contaminated batches of the blood thinner heparin from China.
"I'm just concerned in general about products coming from China," says Beth Najberg, who designs corporate training programs in Chicago. She looked for the origin of her generic thyroid medication -- levothyroxine -- on the maker's Web site, but didn't learn much.
The FDA requires drug companies to disclose only the name and place of business of the manufacturer of prescription drugs. Ingredients must be listed on the label, but not the raw materials or their origins.
Most modern medications are synthesized from chemicals in laboratories, but some include biological agents as diverse as whale sperm and human blood parts. Suppliers range from itinerant fishermen to giant chemical companies. Besides the active ingredients, a single pill may include dozens of fillers and bulking agents, each of which has its own supply chain.
Drug companies say making such information public would be neither practical nor helpful to consumers, and that what counts is that any medication sold in the U.S. must meet Good Manufacturing Practices set by the FDA. "The requirements, if it's made in Nutley, N.J., or a foreign country, are exactly the same," says Lori Reilly, vice president for policy and research at Pharmaceutical Research and Manufacturers of America, a trade group.
But ensuring that those rules are met is up to the companies. The FDA doesn't have the resources to inspect overseas facilities, where 80 percent of the active ingredients in U.S. drugs originate. The Government Accountability Office says that at the current rate, it would take the FDA 13 years to inspect each existing foreign establishment once. The House Energy and Commerce Committee plans to reintroduce a bill that would ramp up FDA inspections overseas and call for country-of-origin labeling for active drug ingredients.
Would more labeling enhance safety? Even consumer watchdog groups aren't sure.
"The devil is in the details. Would you list the finished product, or the raw ingredient or the raw-er ingredient?" asks Peter Lurie, deputy director of the health research group at Public Citizen.
Unlike toys and toothpaste, drugs usually aren't optional or interchangeable. "What does it mean that most heparin in the world is coming from China if you need heparin?" asks Karen Riley, an FDA spokeswoman.
Tips for spotting counterfeit meds
• Buy from a U.S. state-licensed pharmacy you trust. Be wary of online sellers that don't include contact information, don't require a doctor's prescription or don't bear a seal from the Verified Internet Pharmacy Practice Sites, or VIPPS.
• Look closely at the pills. Just as with knockoff handbags, there are often telltale imperfections. Changes in color, taste or smell can also be red flags.
• Check that "tamper-evident" packaging is intact. Misalignments or sticky residue can indicate a seal has been broken and replaced.
• If you are taking medication for a specific symptom, monitor how you feel. If your drug isn't working as it is supposed to, tell your doctor.