NEWSBREAKS
MAJOR STORIES FOR PHARMACISTS AT DEADLINE

'Help us' fight drug imports, FDA urges state boards

In the midst of an uphill battle against illegal drug importation being championed by senior citizen groups and politicians, Food & Drug Administration officials urged state pharmacy boards to help the agency keep the U.S. drug supply safe.

The setting may have been Philadelphia, but the real focus of the 99th annual meeting of the National Association of Boards of Pharmacy was several hundred miles north. Having launched several enforcement actions against storefront prescription brokers in recent weeks, the FDA appealed to state pharmacy regulators to help the agency grapple with the legal and patient safety issues posed by Canadian Rx imports that may top $1.4 billion this year.

The number of Canadian pharmacies shipping drugs into the United States has doubled in the past three months, to 113, according to William Hubbard, FDA associate commissioner for policy and planning. He was joined by Thomas McGinnis, R.Ph., FDA director of pharmacy affairs. They reported that an estimated 100 Web sites advertise as Canadian pharmacies but may actually be shipping drugs from other countries, such as Namibia.

"Please work with us," Hubbard urged attendees. "We are committed to doing something about this vexing problem that's undermining the safety of our drug supply. We're looking for good examples of consumers getting the wrong drugs or counterfeits. If you find evidence that a drug has caused harm, let us know and we'll help get the message out. The FDA has a big megaphone."

A joint position statement on cross-border Rx trade was announced by NABP and its Canadian counterpart, the National Association of Pharmacy Regulatory Authorities. The groups pledged to cooperate to promote compliance with federal, state, and provincial laws and standards of the United States and Canada.

Regulations outlawing Rx imports must be enforced, said NABP executive director Carmen Catizone. However, if the current laws cannot be enforced or only serve to enhance the economic interests of a particular entity, the laws must be changed, he added.

"If the laws need to be changed," Catizone told attendees, "then those changes should provide for the mutual recognition of medications between the FDA and Canada's comparable drug approval agency and require that Canadian pharmacists and pharmacies be licensed and/or registered with U.S. boards of pharmacy so as to comply with the appropriate laws and regulations."

Carol Ukens

 

Carol Ukens. 'Help us,' fight drug imports, FDA urges state boards. Drug Topics May 19, 2003;147:14.