Even though it will be two months before a task force charged with deciding whether reimporting drugs from other countries is safe and cost-effective, state governments in Vermont and Illinois have made headlines recently by proposing their own importation programs.
Anyone who's followed the contentious issue knows that federal law doesn't allow Americans to reimport FDA-approved drugs from other countries, but the agency has done little to enforce the regulation. However, agency policy does allow Americans to import a 90-day supply of unapproved prescription drugs.
At issue here is the cost of prescription drugs and the attempt by state governments to provide their citizenry with more affordable medications.
The Bush administration and Congress took up the reimportation issue in the new Medicare law, which will allow reimportation if Tommy Thompson, secretary of the Department of Health and Human Services, certifies that it is safe. The task force has been studying the issue and is expected to release a report after Election Day, much to the chagrin of some politicians like Sen. Orrin Hatch (R-Utah), who publicly criticized the move as political strategy.
Whatever the case, Vermont, under the leadership of Gov. Jim Douglas, in August filed suit against the FDA in the U.S. District Court in Burlington, becoming the first state to challenge the agency's legal arguments for blocking reimportation proposals.
Vermont had sought a waiver from the FDA authorizing a pilot drug reimportation plan. The goal of the project was to demonstrate how a plan could be safely implemented and ultimately serve as a model for other states to implement similar programs, a statement from Douglas' office said.
Vermont is arguing that the FDA's decision prohibiting the proposal was "arbitrary and capricious, and otherwise unreasonable" and in direct violation of the new Medicare law. The state is seeking a court order that would "require prompt adoption of regulations and waiver guidance and appropriate consideration of Vermont's program," the statement said.
The FDA responded, issuing its own press statement, saying it believes Vermont's proposal to import drugs would be inconsistent with the FDA's statutory responsibility to protect the nation's drug supply and with its personal importation policy.
Moreover, the agency said it denied Vermont's request because Thompson hasn't certified that such a policy would be safe.
The agency deferred to the task force report, saying "the completion of this required study is critical to making an informed decision as to whether the drug importation program in [the Medicare law] can be implemented safely."
Meanwhile, Illinois Gov. Rod Blagojevich in August said his state would implement its own online system to establish a clearinghouse of state-inspected and approved pharmacies and wholesalers in Canada, Ireland and the UK.
A few days after announcing the plan, the governor was back in front of the cameras complaining about a Pfizer Inc. policy to adjust its contracts with British drug wholesalers.
Blagojevich believes the New York-based company is trying to deny Illinois residents access to cheaper drugs by limiting supplies to wholesalers who sell back into the U.S., but Pfizer maintained it is trying to protect consumers.
Interference of the cross-border supply chain could compromise patient safety, the company said. Pfizer cites instances of counterfeit versions of its drugs turning up in the UK and Turkey.
Also, the company is concerned that such reimportation policies create supply shortages in other countries.
Pfizer and other companies, including London-based GlaxoSmithKline plc, implemented similar policies in Canada to stop pharmacies from exporting prescription drugs back into the U.S. (See BioWorld Today, Aug. 11, 2003.)
Californians Consider Bankrolling Stem Cell Research
When California voters go to the polls Nov. 2, not only will they vote for a president, but they'll also decide whether the state should provide about $3 billion to fund human embryonic stem cell research over the next decade.
Specifically, Proposition 71 would provide on average $295 million a year over 10 years in tax-free state bonds to support stem cell research, said Californians for Stem Cell Research and Cures. The initiative was developed by a coalition of California families, disease organizations and medical experts determined to close the funding gap for stem cell research.
Proposition 71 is supported by a growing coalition of grassroots supporters that already includes Nobel Prize-winning scientists and medical experts, families involved in patient advocacy and efforts to cure diseases, and organizations like the California Medical Association, American Nurses Association of California, American Diabetes Association, Christopher Reeve Paralysis Foundation, Juvenile Diabetes Research Foundation, Elizabeth Glaser Pediatric AIDS Foundation, Sickle Cell Disease Foundation of California, ALS Therapy Development Foundation, Parkinson's Action Network and the National Coalition for Cancer Research.
On the other side of the issue, the Christian Medical Association (CMA), of Washington, released a statement Friday opposing Proposition 71 saying it would allow the creation of cloned human beings and then mandate that they be killed.
"Sacrificing embryos for their stem cells crosses the moral and ethical line that has prohibited harmful research on humans," said David Stevens, executive director for the CMA. "Once we succumb to the false principle that medical benefits justify exploitative research, there will be an ever-expanding group who will become targets of harmful research in the name of medical progress. The process of so-called therapeutic cloning and reproductive cloning is the same. The only difference is what you do with the clone after it is produced."
Former California Gov. Gray Davis was the first state leader to sign legislation authorizing human embryonic stem cell research and offering to help pay for it. (See BioWorld Today, Oct. 17, 2002.)
New Jersey Gov. James McGreevey signed similar legislation. (See BioWorld Today, Jan. 6, 2004.)