By Ed Koch

One problem Americans face is the skyrocketing cost of prescription drugs. As we live longer and rely on more medications for various ailments, drugs require an ever larger portion of the family budget. In 2004, the federal government adopted Medicare Part D to help pay a portion of the cost of these drugs, but drug prices are still too high for many moderate-income families and individuals.

Earlier this year, eight states and the District of Columbia adopted procedures under which their citizens would be able to purchase prescription drugs made by American manufacturers and sold in Canada at prices far less than those sold in the U.S. Those states are: Nevada, Missouri, Kansas, Vermont, New Hampshire, Illinois, Minnesota and Wisconsin. I recently wrote to several governors asking how the program was working.

Valerie M. Rosalin, Director of Nevada’s Consumer Health Assistance Bureau, responded on behalf of Nevada Governor, Kenny C. Guinn. Excerpts of her July 26, 2006 letter follow:

“This letter is in response to your inquiry and our conversation regarding the Canadian Drug Program in Nevada…This program was available to Nevadans about May 20th. The four Canadian pharmacies were visited and licensed by the Nevada State Board of Pharmacy. These steps were taken to provide the safest means of ordering Prescription drugs from Canada.

“The regulations regarding the ordering of prescriptions from Canada are clear on the website, no control drugs, injectibles nor brand or generic drugs that are not FDA approved. The FDA still has not formally approved this drug importation but there is now a Bill introduced in Congress that may do that in the future.

“United States Customs occasionally will confiscate prescriptions from Canada, but notify the consumer, usually with a letter. The consumer will call the pharmacy (as he would if he bought through a US mail order) that the RX was confiscated, may be required to fax copy of the letter, then will receive another prescription sent out.

“We have no means of knowing how many Rx’s have been filled because of the Privacy Act.  We just get ‘hits’ from the webmaster.”

On June 21, 2005, I had written to Governor George Pataki as follows:

“Dear Governor: I am enclosing a copy of an article which appeared in today’s New York Times reporting on an action taken by Governor Kenny Guinn of Nevada. The article reports, ‘Nevada will begin inspecting and licensing Canadian pharmacies, which will then be listed on a state-run Web site. Eight states and the District of Columbia operate similar programs.’

“Apparently, this will give Nevadans access to cheaper prescription drugs.

“Is New York among the eight states operating such a program? If not, wouldn’t it make sense for you to make New York the ninth state?”

On August 10, 2005, I received an answer from Mark Kissinger, Deputy Secretary to the Governor for Health and Human Services. His excerpted response follows:

“We have been monitoring the actions of state and local governments regarding this type of program, and find that we have a number of concerns about this approach. The Department of Health has significant concerns regarding the quality and safety of prescription medications being dispensed through such a program, as there is limited ability to enforce quality standards for pharmacies operating outside of New York. Nor is there a reliable means to assure that drugs shipped from such pharmacies consistently meet either the Food and Drug Administration (FDA) or Canadian quality standards.

“In addition, under the Federal Food, Drug and Cosmetic Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. As part of the FDA’s standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug’s ingredient on a new drug application, the FDA generally travels to that site to inspect it. After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices.

“Along with legal requirements on manufacturing, U.S. pharmacists and wholesalers must be licensed or authorized in the states where they operate, and limits on how drugs can be distributed lessen the likelihood that counterfeit or poor quality drugs will turn up.

“Most importantly, New York State does not have the legal authority to license pharmacies in Canada, as proposed in the article attached to your letters. New York State would be limited in the actions that could be taken against Canadian pharmacies that violate established safety requirements.

“I certainly share your interest in assuring that New Yorkers can gain access to affordable prescriptions. New York has an outstanding record of providing affordable prescription coverage for older New Yorkers through the Elderly Pharmaceutical Insurance Coverage (EPIC) program, and to families through the Family Health Plus and Child Health Plus programs. With these programs we are able to establish and carefully monitor the quality of pharmaceuticals being dispensed.”

Why hasn’t Congress, particularly its Democratic members, sought to enact legislation that would permit the Social Security Administration to use its purchasing power to buy prescription drugs from drug manufacturers? Such use of mass buying power is prohibited under a provision in the existing law by the Bush administration supported by the drug manufacturers for obvious selfish reasons. The Bush administration favored these special interests. Democrats, with a few Republican allies, should work to reverse that decision. New York used to be the state that other states followed with regard to providing social services. What happened to the Empire State’s tradition of innovation?

Former New York City Mayor Ed Koch can be heard every Friday at 6pm on Bloomberg Radio.