Statement of the U.S. Food And Drug Administration
Before the Nevada State Board of Pharmacy
April 20, 2006
INTRODUCTION
The Food and Drug Administration (FDA) appreciates this opportunity to submit testimony on issues relating to the Nevada State Board of Pharmacy licensing Canadian pharmacies for importation of prescription medications into the State of Nevada.
At FDA, one of our essential statutory responsibilities is to help assure the American public that the drug supply is safe, effective, secure, and reliable. For more than 60 years, the Federal Food, Drug, and Cosmetic Act (FD&C Act) has been the cornerstone of a regulatory system that ensures that Americans can be confident that, when they use an FDA-approved drug, the medicine will be safe and effective and will work as intended in treating their illness. FDA is deeply concerned about unapproved, imported prescription drugs whose safety and effectiveness cannot be assured because they are outside the legal structure and regulatory resources provided by Congress.
GENERAL SAFETY CONCERNS RELATING TO IMPORTATION
The drug distribution network for legal prescription drugs in the U.S. is a "closed" system that involves several players (e.g., manufacturers, wholesalers, pharmacies) who move drug products from the point of manufacture to the end user, and provides the American public with multiple levels of protection against receiving unsafe, ineffective, or poor quality medications. This system evolved as a result of legislative requirements that drugs be treated as potentially dangerous consumer goods that require professional oversight to protect the public health. The result has been a level of safety for drug products that is widely recognized as the world's "gold standard."
Legalized importation of drugs authorized by the State of Nevada creates an opening in the "closed" system that will likely result in some increase in risk, because evidence shows there are weaknesses in the oversight of the drug distribution system by foreign governments for drugs that are imported into the U.S. We have found that although "Canadian pharmacies" purport to dispense drugs that are FDA approved, generally the drugs, in fact, are not. Rather, the dispensed drugs are of unknown quality and country of origin.
Furthermore, drugs that are outside the U.S. "closed" system, may not have been packaged and stored under appropriate conditions to prevent degradation, and there is no assurance that these products were manufactured under current good manufacturing practice (cGMP) standards. When consumers take such medications, they face risks of dangerous drug interactions and/or of suffering adverse events, some of which can be life threatening. More commonly, if the drugs are subpotent or ineffective, the patient may suffer complications from the illnesses that their prescriptions were intended to treat, without ever knowing the true cause.
Although some purchasers of drugs from foreign sources may receive genuine product that was made by the same manufacturer in the U.S., others may unknowingly buy counterfeit copies that contain only inert ingredients, legitimate drugs that are outdated and have been diverted to unscrupulous resellers, or dangerous sub-potent or super-potent products that were improperly manufactured. There is no way to tell the difference without doing a resource-intensive, time-consuming, laboratory analysis of each shipment that comes to the U.S.
The current system of drug regulation in the U.S. has been very effective in protecting public safety, but is facing new threats with the passage of the State of Nevada's SB5. Safety and protection of the public health are paramount; safety should not be sacrificed for affordability.
IMPORTATION OF PRESCRIPTION DRUGS UNDER THE NEVADA LAW
With respect to the Nevada law, FDA has previously expressed its concerns in licensing Canadian pharmacies to import prescription medications to both Governor Guinn and the Nevada State Board of Pharmacy. Let me summarize our concerns that are relevant to your deliberations.
In a May 20, 2005 Letter to Governor Kenny Guinn, Governor of Nevada the FDA outlined the following points specific to FDA approved drugs:
- FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, packaging location, container/closure system, and appearance.
- Generally, drugs sold outside of the United States are not manufactured or packaged by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus is unapproved.
- In 1988, Congress enacted the Prescription Drug Marketing Act (PDMA) to establish additional safeguards to prevent substandard, ineffective, or counterfeit drugs from entering the U.S. Under PDMA, it is illegal for anyone other than the drug's original manufacturer to re-import a prescription drug into the U.S. that was manufactured in the U.S. Therefore, if an entity or person that is not the manufacturer of that drug imports a U.S.-made prescription drug into the State of Nevada from Canada, that importation would violate the FD&C Act. This is true under Nevada's importation legislation that purports to legalize the conduct under state law. Furthermore, the drug importation scheme set forth by Congress preempts conflicting state or local legislation that would legalize the importation of certain drugs from Canada in contravention of the FD&C Act.
- There are many sources of civil and criminal liability for parties who violate the FD&C Act.
In a September 22, 2005 Letter to Larry Pinson, PharmD, Executive Director, Nevada State Board of Pharmacy, the FDA outlined these additional points:
- FDA does not have information regarding the products approved by Health Canada, so we cannot assure that they are the same as FDA-approved products. Consequently, how does the State of Nevada expect to make the distinction?
- Additionally, according to a letter we received from Canadian officials, Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.
We also would like to raise the following additional concerns. The Nevada law does not provide for a recall of imported products that are recalled in Canada but not in the U.S. It has been our experience in the past that products recalled in Canada may not be recalled in the U.S., since they were made in different manufacturing facilities or to different specifications. With the law lacking a provision to notify Nevada patients if there are health alerts and recalls of the medicines exported from Canada, patients are put at an unnecessary risk. Also, with some recalled medications patients may need replacement medicines very quickly.
We also note that the law does not require that products have adequate labeling to ensure safe use. In the absence of appropriate labeling, physicians and consumers are unlikely to know the identity of all the inactive ingredients in a Canadian drug without consulting the Canadian Physicians Desk Reference, which is not generally available in the U.S. This could frustrate efforts to prevent allergic reactions. In addition, patients may not get the FDA-approved medication guide or risk management plan for those drugs with serious or significant side effects.
Moreover, under the law, physicians, pharmacists and patients would be unable to judge properly whether products are truly substitutable. Some consumers' health may be at risk, since some medications that are safe and effective only in a narrow therapeutic range, such as anti-seizure medications, may be replaced with foreign versions that are not substitutable or whose therapeutic equivalence to U.S. versions is unknown to American health care providers.
We note that the Nevada law states that pharmacies, to be licensed, must comply with all applicable federal laws, regulations and standards. Sales by Canadian pharmacies that are licensed by the Nevada Board of Pharmacy to sell unapproved drugs to Nevada residents would violate the federal FD&C Act. Thus the licensing of such pharmacies will lead to actions in violation of your law.
Moreover, this same provision in the Nevada law cannot offer adequate protection that Canadian pharmacies will comply with all applicable federal laws regulations and standards. In fact Nevada law enforcement officials have no jurisdiction over Canadian businesses. Suspension or revocation of licenses is in general inadequate to ensure such compliance because pharmacies in Canada could make money by opportunistically acting in violation of such laws regulations and standards. For example, a Canadian pharmacy dispensing drugs to Nevada residents could sell sensitive medical information about U.S. patients that in the U.S. would be protected by the Health Insurance Portability and Accountability Act. In the event of abuse of such information in Canada, the only recourse would be for the Nevada Board of Pharmacy to revoke the pharmacists' license to import.
CONCLUSION
The standards for drug review, approval, and oversight in the U.S. are the best in the world, and the safety of our drug supply mirrors these high standards. We remain vigilant to protect the integrity of medications within the U.S. "closed" distribution system. The Nevada law creates a legislative opening in our valued "closed" system because the FDA cannot regulate the Canadian drug distribution system that would supply the citizens of Nevada with Canadian pharmaceuticals.
Thank you for the opportunity to submit testimony.
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