Faced with increasing prescription drug prices, some American patientsand some law makersare looking at drug reimportation as a way to lower their health care costs. Patients have been shopping on-line or traveling abroad to find savings. State and federal legislators are trying to determine whether patients should be allowed to reimport medicines or whether there are savings in doing so.
Reimportation raises significant concerns about maintaining and ensuring the continuation of a safe and secure drug supply system for American patients, a healthy generic drug industry, and the availability of affordable generics. Because these concerns have yet to be addressed by federal law makers, the generic pharmaceutical industry remains opposed to reimportation. If Congress believes that it is necessary to pursue reimportation legislation, however, legislators first must address several issues to limit the unintended and negative impacts such proposals would have on cost and quality.
Cost Savings Through Generics, Not Imports
Many patients recognize that generic medicines cost less than their branded counterparts. What they may not realize, however, is that generics purchased in the United States remain less expensive than medicines purchased in Canada. Therefore, importation programs should be structured to maximize potential cost savings by including only branded drugs with no generic competition. Without such parameters, permitting the importation of generic drugs has great potential to be counterproductive. US generic drugs are not only cheaper than potential imported branded drugs, but also, according to a US Health and Human Services Department study published in December 2004, are, on average, 32% less expensive in the United States.
Thus, it seems counterintuitive to permit entry of branded and generic imports if there is a less expensive generic already available to patients here at home. Any proposal to loosen the restrictions on imports should take into consideration the cost savings already available through US generic drugs.
The problem of prescription drug counterfeiting is not limited to developing countries; it has become a growing problem worldwide. Counterfeit prescription drugs have been repackaged and reformulated in foreign countries and then introduced into legitimate distribution channels. Counterfeiting activities are well-orchestrated business enterprises, with the intention of diverting products for robust markets such as the United States and Australia. Given the gravity and breadth of the worldwide counterfeiting epidemic that plagues the pharmaceutical industry even under the current system, adequate safeguards must, at a minimum, remain intact.
Additionally, the resources given to the FDA to inspect and regulate imported drugs would be better utilized on a limited sample of the drug market to minimize safety concerns and administrative burdens. If Congress were to permit the importation of generic drugs and their branded counterparts, it would be encouraging the use of prescription drugs that may be more costly than the generic drugs currently available in the United States, while substantially adding to the burden placed on the FDA by importation.
Product Labeling to Ensure Patient Safety
If an imported drug is therapeutically inequivalent to the FDA-approved domestic brand drug, patients should be made aware of the difference through product labeling. To be therapeutically equivalent, the drug must not only have the same active ingredient or ingredients, route of administration, dosage form, and strength as its counterpart, but must also be bioequivalent. Generic drugs are required to be therapeutically equivalent to the reference branded drug before they can be considered by the FDA to be interchangeable with their FDA-approved domestic brand counterparts. Being therapeutically equivalent allows the generic to be substituted for the brand without any adverse effects for the patient. Thus, if an imported brand is not considered to be therapeutically equivalent to its domestic alternative, the FDA should be given the authority to label drug products accordingly to ensure that health care professionals and patients are empowered to make well-informed decisions before switching between medication products.
There is another serious reason for product labeling: certain drugs may have one name in the United States and a different name overseas. Even worse, 2 entirely different drugs may have the same name in different countries. For example, in the United States, Norpramin (desipramine hydrochloride USP) is an antidepressant; in Spain, it is an ulcer drug. In such a case, mix-ups could have serious consequences.
FDA Oversight and Resources
The FDA must be provided with adequate resources to oversee and ensure the safety of America's drug supply. Without adequate resources and the time to train the requisite number of specialists to oversee such a critical program, the agency will be hard-pressed to implement the necessary safeguards, provide the requisite oversight, and take appropriate enforcement actions to ensure that this nation's drug supply system remains secure. Patients should be confident that the same strict standards that regulators require for domestic branded and generic drugs will be in place for imported drugs as well.
Providing the FDA with the resources to sufficiently oversee all drug importations will help to prevent America's drug supply chain from becoming vulnerable to an influx of inferior and/or potentially dangerous medicines. In addition, adequate patient safeguards must be in place to ensure that unregulated imported products meet all applicable US standards as a prerequisite of importation.
Balance of Innovation and Access
Lastly, any importation program should protect the important balance between innovation and access to generics by prohibiting importation during the 180-day exclusivity period for generic companies. By allowing importation during this vital period, current importation proposals could undermine the well-crafted compromise that provides the critical incentive for generic companies to challenge invalid patents and bring affordable medicines to the market years ahead of the expiration date of the invalid patent. The 180-day period has been an extremely important reason why the generic industry has thrived over the past 20 years by bringing patients accelerated access to affordable medicines. Changes enacted under the 2003 Medicare Modernization Act were designed to restore its original value and effectiveness.
Through challenges to invalid patents, generic drugs have brought billions of dollars of savings to patients. In one case, a successful challenge to the antidepressant drug Prozac (fluoxetine hydrochloride) brought generic competition to the market 3 years early, saving $2.5 billion on that drug alone. If the importation of foreign drugswhich may not be therapeutically equivalentis permitted during the 180-day period, however, it will destroy the carefully crafted balance between innovation and access that Congress has worked so hard to achieve.
As the debate about reimportation continues, Congress should look to generic pharmaceuticals as a safe, reliable solution to the problem of increased costs of prescription drugs. Increasing access to and utilization of generic drugs would benefit all patients, businesses, and government purchasers, through lower out-of-pocket and insurance costs.
Kathleen Jaeger, RPh, President and CEO, Generic Pharmaceutical Association
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