FDA makes moves to block foreign drug imports

Apr 13 2004

The Food and Drug Administration today announced a new partnership with the Virginia Pharmacists Association to distribute consumer educational materials outlining the risks of purchasing medicines outside of FDA’s regulatory scope. Over the past month, FDA has co-sponsored agreements with state pharmacists associations in Illinois, California, Texas, Maryland, New York, and Nebraska, and the Agency anticipates that additional agreements will be signed in the weeks ahead.

“When Americans import medicines illegally, they are faced with a dangerous ‘buyer-beware’ situation," said Dr. Lester M. Crawford, Acting FDA Commissioner. “Medicines bought from other countries may be counterfeit or adulterated, and FDA cannot guarantee their safety. FDA’s ‘Looks Can Be Deceiving’ campaign is about spreading the message of consumer safety and educating Americans on how they can better protect their health."

As part of the Agency’s consumer outreach effort, FDA also recently signed an agreement with the National Community Pharmacists Association to post FDA’s educational materials on the NCPA website. Additionally, FDA has partnered with drugstore chains such as Thrifty White Drug Stores, Inc. in Minnesota to support this public information campaign.

The “Looks Can Be Deceiving" education campaign uses posters, prescription bag inserts, fliers and tabletop displays to remind pharmacy customers in straightforward language that imported drugs pose a safety risk. The materials list a number of concerns, including counterfeit drugs, untested substances, lack of quality assurance, and unsupervised use of drugs. They warn, “Looks can be deceiving. … Don’t risk your health."

“The pharmacist plays an important role in guiding patients with their medication decisions," said Carmen Catizone, Executive Director of the National Association of Boards of Pharmacy. “The ‘Looks Can be Deceiving’ program helps patients understand the problems with illegally imported drugs and provides a way to work with your pharmacist to use medications safely."

According to recent data from IMS Health, approximately $1.1 billion in pharmaceuticals were imported into the U.S. in 2003 (based on U.S. prices), despite federal laws prohibiting such actions. FDA, pharmacists, and pharmacy regulatory officials across the country are increasingly concerned about the safety risks associated with such importation. In January 2004, FDA announced that a series of examinations conducted with the U.S. Customs & Border Protection (CBP) revealed 1,728 unapproved drugs among the 1,982 parcels inspected; this included so-called “foreign versions" of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring and drugs containing addictive controlled substances. This "snap" inspection followed an inspection in July and August 2003, which found that 88% of the 1,153 imported drug products studied contained unapproved drugs.

The FDA has repeatedly encouraged alternative solutions to illegal drug importation that ensure both safety and affordability. For example, the FDA is currently undertaking a major initiative to educate consumers on the use of generic drugs. FDA-approved generic drugs are just as safe and effective as brand-name drugs, and cost as much as 70 percent less. Recent data also indicate that U.S. generic drugs are in fact cheaper than both Canadian branded drugs and Canadian generic drugs (see http://www.fda.gov/oc/whitepapers/drugprices.html). FDA is actively pursuing new regulations and systems to speed access to generic drugs and help save consumers billions of dollars annually.