The Bush administration and Maryland pharmacists are staging a public relations campaign aimed at scuttling a state Senate proposal that would help state employees, retirees and Medicaid recipients buy lower-price prescription drugs from Canadian mail-order pharmacies.
Sen. Paul G. Pinsky, a Prince George's County Democrat, is chief sponsor of the legislation, which he says would prevent Maryland residents from "being gouged unmercifully by the pharmaceutical companies."
The bill, which has 21 co-sponsors, two short of a majority in the 47-member Senate, is scheduled for a public hearing in the Senate Finance Committee this afternoon.
Just before the hearing, the federal Food and Drug Administration and the Maryland Pharmacists Association plan to start a statewide campaign in Annapolis to dissuade consumers from buying medication by mail from foreign pharmacies.
Their "Looks Can Be Deceiving" campaign is to use posters, prescription bag inserts and fliers to warn pharmacy customers that foreign mail-order drugs could be counterfeit.
"The first duty of a pharmacist is to make sure the drug he dispenses is pure, unadulterated and in the strength prescribed by the physician," said Howard Schiff, the association's executive director.
"If this bill passes, there is no way we could guarantee the [imported] drugs' safety because they would be dispensed without FDA approval."
Maryland is the newest front for an embattled FDA that is trying to quell a sagebrush rebellion against prescription drug prices that are typically 30 percent to 50 percent higher in the United States than in Canada and other nations that control medicine prices.
The pharmaceutical industry says price controls would stifle research into new medicines.
The battle rages in Rockville, where the FDA has its headquarters. The Montgomery County Council is considering whether it should follow Springfield, Mass., where the local government has set up a reimportation program for its employees and retirees.
Montgomery, whose annual budget for prescription drugs has doubled to $70 million in five years, estimates that it would save about $10 million on its top 100 medications with an importation program, said Dan Parr, an aide to the plan's sponsor, council member Tom Perez.
Thirty-seven drug-importation measures are being considered in 19 states, according to the National Conference of State Legislatures. So far, only Vermont has passed a reimportation bill - a nonbinding resolution directing its governor to establish a reimportation program.
The governors of Minnesota and Wisconsin have introduced Web sites making it easy for residents of those states to buy drugs from Canadian pharmacies that have been approved by their states' inspectors.
Illinois has sent its drug-reimportation plan to Health and Human Services Secretary Tommy G. Thompson, and North Dakota has announced that it will soon follow Illinois' lead.
An elderly Illinois couple, Ray and Gaylee Andrews of Elk Grove, filed a class-action suit against FDA and HHS last week, claiming that it is unconstitutional to prevent them from buying lower-priced drugs from foreign pharmacies. The couple say their $800 monthly medication bills have eaten up their life savings.
In Congress, three Democratic and two Republican senators have introduced a bill that would allow the importation of lower-priced medicines from 25 industrialized countries. Republican Gil Gutknecht of Minnesota introduced a House bill that would allow the importation of drugs if they are manufactured by companies that use "counterfeit-resistant technologies" and register with the FDA.
"The winds of change are happening whether it's in our state today or in the federal government," Pinsky said.
In an effort to appease the rebels, the Bush administration announced last week that it would conduct a yearlong study of drug reimportation. Its appointment of a foe of the practice, FDA Commissioner Mark McClellan, to lead the study infuriated reimportation backers on Capitol Hill.
One, Sen. Byron Dorgan, a North Dakota Democrat, said the appointment was "like putting the fox in charge of the chicken house."
At the heart of the reimportation issue is the United States' standing as the lone industrialized nation that does not control the cost of prescriptions. The Medicare reform law that President Bush signed in December prohibits the federal government from negotiating for lower prices on medicines that it will provide for seniors in a drug benefit that is to begin in 2006.
The Bush administration estimates that benefit will cost $534 billion over 10 years.
Pinsky's bill calls on Maryland Health Secretary Nelson J. Sabatini to implement a Canadian mail-order drug plan by July 1 next year as a way of reducing state spending on medicines for its employees, retirees and Medicaid beneficiaries. State spending on prescription drugs has risen 18 percent a year over the past three years, he said.
In an interview, Pinsky said he plans an amendment that would widen the program to include local governments. "We've got a pretty compelling case that this bill could help a lot of people," he said. Lawmakers "are hearing it back home. It's a no-brainer for the people back home," he said.
The Ehrlich administration has not taken a position on the measure, but Sabatini expressed opposition to drug-reimportation programs during a December interview. "If everybody starts doing that," he said, "there aren't going to be enough drugs for the Canadians."
The Pinsky bill is likely to be opposed additionally by Maryland's biotech industry, which says it includes 300 biomedical companies and 16,000 employees. Two industry leaders expressed opposition to the Montgomery reimportation plan in a November letter to County Executive Douglas M. Duncan.