ANNAPOLIS – Comparing his effort to acts of civil disobedience during the Civil Rights era, a Maryland senator is proposing legislation that would defy federal law by allowing the state to set up a program to import less expensive prescription drugs from Canada.
In the bill called the “Canadian Mail Order Plan,” the state would negotiate directly with Canadian pharmacies on behalf of residents for low-cost drugs. The prescription drugs, which would have to be priced below their American counterparts to qualify under the program, would be purchased directly from Canadian companies over a state-operated Web site, according to David F. Kahn, a legislative aide working on the bill.
At a hearing on the bill Wednesday, chief sponsor Sen. Paul G. Pinsky, D-Prince George’s, said consumers could save as much as 25 to 50 percent by purchasing lower-priced drugs from Canada.
The importation of foreign prescription drugs would fly in the face of federal law since the drugs would be unapproved by the Food and Drug Administration. But Pinsky said that circumventing federal law is justified because the government hasn’t done enough to make prescription drugs less expensive.
“Sometimes you have to break the law,” Pinsky said in an interview outside the Senate committee room. ” … When Rosa Parks sat down in the bus, it was against the law. She did it because it was the right thing to do. I think this is the right thing to do.”
He also said that because the FDA has not pressed charges on other states importing prescription drugs from Canada, Maryland should “push the envelope,” in terms of going forward with such legislation.
The bill may also find support from Gov. Martin O’Malley who talked about ways to import drugs from Canada during his campaign. According to spokesman Rick Abbruzzese, the governor supports any effort to make drugs more affordable, and he is reviewing the specifics before endorsing the legislation.
The bill came under attack at Wednesday’s hearing from representatives of the pharmaceutical industry, who warned of potential health hazards posed by importing prescription drugs. While the bill spells out a number of safety measures, opponents to the bill deemed them “worthless” without FDA approval.
In a telephone interview, Julie Corcoran, a deputy vice president at the Pharmaceutical Research and Manufacturers of America, who was not present at the hearing, said she was particularly concerned about fake drugs entering the U.S. market, which she said, is the “gold standard” for safety.
“There’s a growing epidemic of counterfeits. [The bill] would introduce counterfeits into the system, putting patients at risk,” Corcoran said.
She said that the state would bear a “heavy administrative burden” of ensuring the safety of the imported prescription drugs. The state would, in effect, have to become a mini-FDA, she said, which would be far costlier than looking for solutions within the existing system.
Without a waiver from the FDA that would legally permit the state to import prescription drugs, Maryland’s Medicaid program would lose prescription drug rebates and federal matching funds for prescription drugs purchased from Canada, according to an analysis of the bill prepared by legislative aides.
Should the bill pass, Maryland would join seven other states that are implementing similar programs.
Montgomery County passed a similar bill in 2004. But the program was never implemented because the county, which was denied a waiver from the FDA needed to import drugs under the law, wanted to avoid any legal hassles prescription drug importation could cause.
Ronald W. Wineholt, vice president of government relations at the Maryland Chamber of Commerce, told the committee passage of the bill would deter potential pharmaceutical companies from locating in Maryland and hurt local pharmacists.
But Pinsky said lower-priced prescription drugs are essential for people who cannot otherwise afford them.
“The federal government is being irresponsible for not bargaining with the drug companies [for lower prices],” he said, contending that the FDA and the White House “are in the same league” as the pharmaceutical companies. “They’re letting them make these obscene profits,” Pinsky said.