Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act.
Learn More »The Andrews case involved two U.S. senior citizens who currently spend between $800 and $1,000 per month on prescription medications for treatment of diabetes, high blood pressure, arthritis, and asthma. The seniors sought to lawfully purchase prescription drugs from Canada, which would have saved them about $400 to $500 a month. The senior citizens stated that the prohibition against purchasing drugs from Canada violated their rights of privacy, rights to equal protection under the law, and deprived them of their liberty and property interests through an arbitrary FDA policy that is not tailored to serve a compelling government interest.
According to the D.C. District Court, the FDA has a legitimate governmental interest in ensuring the safety of prescription medications and the statutory scheme employed furthers this interest by shielding the public from reimported drugs that may be adulterated or otherwise unsafe. Additionally, the FDA is under no duty to tailor its regulation more narrowly because the reimportation ban does not implicate any fundamental interest by preventing access to some medications that are unadulterated and safe.
The Andrews case has limited precedential value at this point; however, it represents one more episode in the ongoing debate over whether the importation or reimportation of prescription drugs from Canada and other foreign countries should be permitted. Reimportation refers to the purchase, by U.S. residents, of U.S.-made prescription drugs sold in foreign countries, whereas importation refers to the purchase of prescription drugs manufactured in foreign countries by U.S. residents. Opponents of importation and reimportation, including the FDA, feel that reimportation presents a danger to American citizens because the FDA is unable to effectively regulate these drugs. Proponents of reimportation are looking to save money on the high price of prescription drugs in the U.S.
According to several government officials, reimportation is neither safe nor feasible at this point. According to Surgeon General Richard Carmona, the Health and Human Services Department (HHS) currently lacks the resources to inspect and ensure the safety of all the prescription drugs shipped to the U.S. from abroad. "Right now, [the FDA] cannot keep up with the volume that's coming in," he said at a recent Senate hearing. However, Carmona said that options for safe importation should be considered. "Every and all opportunities need to be explored," he said. He suggested that commercial importation could be one option, under a system where Congress would decide on the number of portals of entry and decide who should be permitted to manufacture and ship drugs to the U.S. However, even under a limited system, the FDA would need new authorities and more inspectors, said Carmona. "There's no way that they can't ensure safety now, even with a commercial system," he said.
In separate remarks, the Centers for Medicare and Medicaid Services Administrator Mark McClellan said that although commercial importation is feasible, ensuring the drugs safety would be a challenge and the savings from such a system would be small. Many drugs manufactured abroad are not cheaper than the same drugs manufactured and sold in the U.S., McClellan said at a February 1 meeting of the AARP in Washington, D.C. He noted that seniors in the U.S. generally do not pay manufacturer list prices for prescription drugs. In addition, he stated that U.S. generics are "far cheaper" than drugs in either Canada or Europe, due to increased competition among manufacturers of generics in the U.S. During a January 13 teleconference, FDA Associate Commissioner for Policy & Planning William Hubbard said that the December 21 HHS Task Force report found that foreign countries will not assure the safety of drugs imported into the U.S. Drugs shipped from abroad also are difficult to track and manage, he said, warning there is an "increasing threat" of counterfeit drugs.
Will reimportation continue to be an issue?
According to a PricewaterhouseCoopers Health Research Institute report, interest in prescription drug reimportation at the federal level will likely subside once seniors obtain Medicare prescription drug coverage in 2006.Sandy Lutz, research director for the Institute, predicted there will be a push on the issue in 2005 in part because the public is concerned with global price differences. According to the Institute, "seniors' political clout and lack of drug coverage have pushed this to the top of lobbyists' agenda." However, since seniors bear the brunt of high-cost drugs, their interest in the matter may wither by November 2005, when they first start enrolling in drug benefit plans.
Under the terms of MMA, in December 2005 HHS must deliver recommendations to Congress on the oversight and resources needed for the safe importation of drugs. If HHS concludes that reimportation is safe, than President Bush, who has opposed reimportation on safety grounds, may ask the HHS Secretary to certify the safety of reimported drugs.
Meanwhile, many states have passed some kind of legislation that addresses reimportation. For example, in 2003, Minnesota set up a website that allows residents to order drugs from Canada. Maine has passed a measure to request drug makers not to boycott Canadian pharmacies that sell mail-order prescriptions to their residents, and in 2004, Illinois launched the nation's first state-sponsored program to help residents buy cheaper prescription drugs from Europe and Canada.
For more information regarding this topic, see the Food, Drug and Cosmetics Law Reporter. The Reporter provides the full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act. Learn more.
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