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Return to Expedite-Rx Home Page …AND THE WALLS CAME TUMBLING DOWN Tom Curb, R.Ph. Attached are excerpts of two articles forwarded to me. The first was attributed to the Financial Post of Canada. It was dated May 23, 2003, and titled "Insurers can reimburse U.S. patients for Canadian drugs: FDA commissioner rules". Its text was:WASHINGTON - U.S. health insurers are allowed to cover medicines patients buy in Canada, U.S. Food and Drug Administration commissioner Mark McClellan said at a Senate hearing. Senator Byron Dorgan, a North Dakota Democrat, said a February FDA letter to health insurers (the Lombardi reply) indicated that they might violate U.S. law by reimbursing U.S. patients for medicines bought from Canada. But Mr. McClellan testified that the agency (FDA) did not intend to hamper (insurer) coverage of purchases for personal use. Paying for those medicines is "consistent with our (FDA’s) policy of personal importation," Mr. McClellan said. "That's very different from [an insurer] encouraging or advocating or taking steps to promote the use of illegal pharmaceuticals in this country." Mr. McClellan said his agency would discuss the letter with insurance companies." Dr. (FDA Commissioner) McClellan’s statements are important in that they (1) positively and specifically reiterate and reaffirm the permissive position of the FDA with respect to personal prescription importation, and (2) they publicly establish FDA acceptance of an integral role in that process for third party payers. (The latter stance is very much different from misinterpreted, negative implications of the FDA’s infamous "Lombardi inquiry reply" letter that seemed to create such an unwarranted media stir.) While Dr. McClellan’s final statement may be interpreted by some as intent to somewhat restrict the role of third-party payers, it may be an effort to pacify the drug industry by "throwing it a bone". (Certainly, any modern, cost-effective prescription benefit design will encourage members to obtain prescriptions from the most economical source – which in many cases is via personal importation. Because of this, it also follows that an entity liable for the health and safety of its members would be fiscally irresponsible – as well as morally and ethically derelict – if it did not intervene to provide the safest available venue for the process.) Dr. McClellan’s specific reference to "insurance companies" is also significant in that third party payers participating in the Expedite-Rx program - self-funded employee plans and not-for-profit member-funded benefits - are not "insurance companies", but coalitions of "individuals" that are in fact exempt from many insurance regulations. Regardless of how one may argue finite details, the fact remains that Expedite-Rx’s early contentions were on target: (1) The FDA has a long-standing permissive position on personal importation of medications, and (2) the FDA accepts a role for third party payers in that process. The second article was dated May 29, 2003, and appeared in the Palm Beach (Florida) Post as: "Prosecutor: Canadian drug sales no crime". Palm Beach County State Attorney Barry Krischer has given a green light to local storefront businesses that are selling discounted prescription drugs from Canada…"There is not any crime being committed here," Krischer's spokesman, Mike Edmondson, told The Palm Beach Post this week. He said that because the storefronts merely facilitate the filling of legitimate prescriptions through Canadian pharmacies, the businesses are not operating as unlicensed pharmacies… (Krischer’s) decision is significant for two reasons: (1) He is the first of 20 state attorneys in Florida to rule publicly on the issue, and (2) the state Health Department can not take criminal action…without the assistance of a state attorney or the Florida Attorney General's Office. As applies to personal importation in general, the Florida attorney’s ruling is especially important in that it demonstrates a lack of uniformity in states’ attitude about personal importation. This, coupled with Commissioner McClellan’s reinforcement of the FDA’s permissive position should lessen the potential for other states’ agencies and bureaucracies to intervene in the importation process due to pressure from individuals and/or entities with a vested interest in maintaining high US drug costs.
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