Montgomery Drug Plan Has the Votes, but Could Rouse the FDA
By Cameron W. Barr
Washington Post Staff Writer
Wednesday, July 28, 2004; Page B05
A majority of the Montgomery County Council is on record supporting a program that would probably involve importing lower-cost prescription drugs from Canada for county employees and retirees.
That doesn't mean the skeptics in the minority are going to go along without a fight.
Led by council member Michael Knapp (D-Upcounty), who works as a consultant to a Rockville firm that helps to conduct clinical trials for pharmaceutical companies, the skeptics raised concerns yesterday about the safety of a drug importation plan, as well as its legal and administrative ramifications. They also addressed the difficulty of legislating in a fuzzy world where a federal agency says something is illegal and yet moves only gingerly to stop it.
"To the extent we can't rely on a federal mechanism to ensure safety," asked Nancy Floreen (D-At Large), "what administrative mechanism would be necessary at a county level, at least until we have a state program, that would kind of oversee this thing?"
The U.S. Food and Drug Administration, headquartered in Rockville, has long said that importing drugs from Canada is against the law, but some state governments and municipalities have taken steps to organize drug importation programs or make it easier for people to obtain the drugs directly.
FDA officials have not gone to court to stop such action, council member Michael L. Subin (D-At Large) noted. "Until they get their act straight," Subin said, "I don't know how we're going to get any act on the table, much less get it straight." In the midst of conflicting signals about the safety of imported drugs, Subin added, "It's hard for me as a layperson, with no scientific background, to say, 'Oh yeah, they're safe.' "
Knapp prefaced his comments by saying he had sought a waiver from the county ethics commission to discuss the drug import issue, in view of his business background in the biotechnology industry and his continuing work as a consultant. The commission met July 22 and "determined that [Knapp's] participation in [the July 27] work session and subsequent vote on the resolution will not violate the ethics law," according to an e-mail to Knapp from commission executive secretary Barbara McNally.
Knapp said his only consulting client is a Rockville firm, DP Clinical Associates Inc., whose Web site says it provides assistance in conducting clinical trials to "pharmaceutical, biotechnology, and medical device companies." "It's not the pharmaceutical industry, it's a service piece of it," said Knapp, who until December was employed by Celera, a Rockville biotechnology firm he helped found. "I don't consult for anyone who makes or sells drugs."
Knapp read aloud from a July 22 letter the FDA sent to Wisconsin Gov. Jim Doyle (D), whose state Web site refers consumers to Internet pharmacies in Canada. The letter is one of the sternest steps the FDA has taken so far to discourage governments from facilitating drug imports. "FDA urges you to reconsider your website program," the agency wrote Doyle. "Your actions . . . put Wisconsin residents at risk."
The Montgomery drug plan won unanimous approval last week from the council's management and fiscal policy committee, which consists of Howard A. Denis (R-Potomac-Bethesda), Phil Andrews (D-Gaithersburg) and Marilyn Praisner (D-Eastern County). In addition, council members George L. Leventhal (D-At Large) and lead sponsor Tom Perez (D-Silver Spring) are in support, giving the plan five backers on the nine-member council.
County Executive Douglas M. Duncan (D), who would have to implement the program, said he remained open to the idea but had reservations. "The county attorney says it's illegal, so I've got real concerns that you should do anything illegal," he said.
As the plan stands, the county would contract with a pharmacy benefits manager or a similar intermediary that would agree to provide low-cost "maintenance" medications to participants in county health plans. The vendor would also vouch for the safety of the drugs, giving the county a measure of protection should something go wrong.
In order to achieve significant savings, the intermediary would have to purchase drugs from Canada, where government regulations keep prices down. The council will next discuss the matter Sept. 14, after its summer recess.
Staff writer Tim Craig contributed to this report.
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