Source: https://www.fda.gov/Drugs/DrugSafety/ucm179411.htm
Timestamp: 2017-09-25 04:32:08
Document Index: 58569303

Matched Legal Cases: ['§ 355', '§ 352', '§ 353', '§ 331', '§ 381', '§ 314', '§ 355', '§ 352', '§ 201', '§ 381', '§ 331', '§ 314', '§ 381', '§ 331', '§ 332', '§ 333', '§ 331', '§ 333', '§ 333', '§ 381', '§ 333', '§ 331', '§ 381']

Texas: Governor Rick Perry
I write in response to the recent bill passed by the Texas legislature authorizing the Texas State Board of Pharmacy to license Canadian pharmacies to import prescription medications into the State of Texas . It is my understanding that if this bill became law, regulations would be promulgated by the Texas State Board of Pharmacy no later than September 1, 2005 . I wanted to bring to your attention some of FDA's safety and legal concerns with the proposed law.
FDA is very concerned about the safety risks associated with the importation of prescription drugs from foreign countries. In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S. approved prescription drugs have been of unknown origin and quality. We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same as products approved by FDA.
In addition, we note several other specific safety concerns related to the proposed law. First, it 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 proposed law lacking a provision to notify Texas 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 proposed 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 proposed 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 whose therapeutic equivalence to U.S. versions that are not substitutable or whose therapeutic equivalence to U.S. versions is unknown to American health care providers.
The proposed Texas law creates no mechanism to ensure compliance by Canadian pharmacies, other than a threat of cancellation of pharmacy licenses by the Texas Board of Pharmacy. Thus, if a Canadian pharmacy, whose cross border shipments are not regulated in Canada, knowingly decides to profit by shipping to Texas ineffective look-alike drugs originating from dubious sources, it would apparently face no criminal liability and could profit until its fraud is detected. Moreover, the proposed state inspection program extends only to Canadian pharmacies, and not to wholesalers and repackagers. U.S. wholesalers and repackagers are subject to regulatory oversight by both federal and state authorities to prevent unsafe or fake drugs from reaching U.S. consumers.
The proposed Texas law also seems to sanction the importation of foreign drugs in blister-proof packages and manufacturer containers that are not childproof. This violation of federal law could put young children at risk. It would also allow U.S. pharmacists to order medications from Canada for their patients with their patients' consent. This provision invites Texas pharmacists to violate federal law and may expose them to increased tort liability.
It is also unclear whether Canadian pharmacies exporting drugs to Texas would abide by federal laws protecting privacy. A Canadian pharmacy dispensing drugs into the U.S. would have to collect and maintain records on patients' medical history, current medications, allergies, and U.S. physician's name, address, and telephone number-private information protected in the U.S. by the Health Insurance Portability and Accountability Act (HIPAA). In the event of abuse of such information in Canada, the only recourse would be for the Texas Board of Pharmacy to terminate the pharmacists' license to import.
Many of these safety concerns are reflected in the import provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), which strictly limit the types of drugs that may be imported into the United States and who may import them. Congress enacted these provisions to create a relatively "closed" drug distribution system, which helps ensure that the domestic drug supply is safe and effective. Accordingly, if an entity or person were to import prescription drugs into the State of Texas from Canada , that importation would violate the FFDCA in virtually every instance. This is true even if the proposed Texas legislation 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 FFDCA.
The starting point for our analysis is the legal framework applicable to imports of prescription drugs from Canada . 1
First, virtually all prescription drugs imported for personal use into the United States from Canada violate the FFDCA because they are unapproved new drugs (21 U.S.C. § 355), labeled incorrectly (21 U.S.C. §§ 352, 353), or dispensed without a valid prescription (21 U.S.C. § 353(b)(1)). Importing a drug into the United States that is unapproved and/or does not comply with the labeling requirements in the FFDCA is prohibited under 21 U.S.C. §§ 331(d), and/or (a). See also 21 U.S.C. § 381(a).
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. 21 C.F.R. § 314.50. 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 United States approval, and thus is unapproved. 21 U.S.C. § 355. The version also may be misbranded because it may lack certain information that is required under 21 U.S.C. §§ 352 or 353(b) but is not required in the foreign country, or it may be labeled in a language other than English (see 21 C.F.R. § 201.15(c)).
Second, with respect to "American goods returned," it is illegal for any person other than the original manufacturer of a drug to import into the United States a prescription drug that was originally manufactured in the United States and sent abroad (21 U.S.C. § 381(d)(1)). This is true even if the drug at issue were to comply in all other respects with the FFDCA. Importing a drug into the United States in violation of section 381(d)(1) is prohibited under 21 U.S.C. § 331(t).
Thus, to ensure compliance with the FFDCA, any person that intends to import prescription drugs into the United States must ensure, among other things, that it only imports FDA-approved drugs that comply with their FDA approvals in all respects, including manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance. 21 C.F.R. § 314.50. The importer must also ensure that each drug meets all applicable U.S. labeling requirements, and that such drugs are not imported in violation of the "American goods returned" provision in 21 U.S.C. § 381(d)(1).
Practically speaking, it is extremely unlikely that all of the applicable legal requirements will be met if Canadian pharmacies ship drugs into Texas . Consequently, virtually every shipment would violate the FFDCA. Moreover, individuals or programs that cause illegal shipments also violate the FFDCA. 21 U.S.C. § 331 ("The following acts and the causing thereof are hereby prohibited...").
There has been some confusion about whether FDA's Personal Importation policy changes the law with respect to personal imports of pharmaceuticals. The Personal Importation policy is used to guide the agency's enforcement discretion with respect to imports by individuals of drugs for their personal use. Under certain defined circumstances, as a matter of enforcement discretion, FDA allows consumers to import otherwise illegal drugs. Under this policy, FDA permits individuals and their physicians to bring into the United States small quantities of drugs sold abroad for a patient's treatment of a serious condition for which effective treatment may not be available domestically. This approach has been applied to products that do not present an unreasonable risk and for which there is no known commercialization and promotion to persons residing in the U.S. A patient seeking to import such a product is also expected to provide the name of the licensed physician in the U.S. responsible for his or her treatment with the unapproved drug product. See FDA Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations.
However, this policy is not intended to allow importation of foreign versions of drugs that are approved in the U.S. , particularly when the foreign versions of such drugs are being "commercialized" to U.S. citizens. (Foreign versions are often what Canadian pharmacies offer to sell to U.S. consumers.) Moreover, the policy simply describes the agency's enforcement priorities. It does not change the law, and it does not give a license to persons to import or export illegal drugs into the United States .
There are many sources of civil and criminal liability for parties who violate the FFDCA. A court can enjoin violations of the FFDCA under 21 U.S.C. § 332. A person who violates the FFDCA can also be held criminally liable under 21 U.S.C. § 333. A violation of 21 U.S.C. §§ 331(a), (d), or (t) may be prosecuted as a strict liability misdemeanor offense. See United States v. Dotterweich, 320 U.S. 277, 284 (1943); 21 U.S.C. § 333(a)(1). Any such violation that is committed with intent to defraud or mislead or after a prior conviction for violating the FFDCA may be prosecuted as a felony under 21 U.S.C. § 333(a)(2). Separately, it is also a felony to knowingly import a drug in violation of the "American goods returned" provision of 21 U.S.C. § 381(d)(1). See 21 U.S.C. § 333(b)(1)(A). In addition, those who can be found civilly and criminally liable include all who cause a prohibited act under the FFDCA. 21 U.S.C. § 331. To date, FDA has focused its enforcement resources on those who commercialize the practice of importing drugs into the United States from abroad. See United States v. Rx Depot, Inc. , 290 F.Supp.2d 1238 (N.D. Okla. 2003). As a matter of enforcement discretion, FDA generally has not seized drugs from those who have taken buses across the border and then brought foreign drugs back into the United States for their own personal use. Instead, FDA has attempted to educate such citizens about the safety risks associated with consuming foreign drugs. Nevertheless, FDA retains the authority to bring an enforcement action in any case in which a provision of the FFDCA has been violated.
The Supreme Court has held that, under the Supremacy Clause, the enforcement of a state regulation may be pre-empted by federal law in several circumstances: first, when Congress, in enacting a federal statute, has expressed a clear intent to preempt state law; second, when it is clear, despite the absence of explicit preemptive language, that Congress has intended, by legislating comprehensively, to occupy an entire field of regulation and has thereby left no room for the States to supplement federal law; and finally, when compliance with both state and federal law is impossible, or when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Capital Cities Cable, Inc. v. Crisp, 467 US 691, 698-99 (1984) (quotation marks and citations omitted); see also English v. General Electric Co., 496 US 72, 78-79 (1990); Association of Int'l Auto Mfrs., Inc. v. Abrams, 84 F.3d 602, 607 (2nd Cir. 1996).
Courts have thus held that federal law preempts state law when, inter alia , Congress has intended to occupy a field of regulation comprehensively (termed "field preemption"). See English v. General Electric Co., 496 US at 78-79; Choate v. Champion Home Builders Co., 222 F.3d 788, 792 (10th Cir. 2000).
Congressional intent to occupy a field comprehensively can be shown any of three ways: 1) when, based on the pervasiveness of the federal regulation, it may be inferred that Congress "left no room for the States to supplement it"; 2) if the federal statute "touch[es] a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject"; or 3) when the state regulation "may produce a result inconsistent with the objective of the federal statute." Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 713 (1895) quoting Rice v. Santa Fe Elevator Corp., 331 US 218, 230 (1947).
In the instant matter, Congress set forth a comprehensive importation scheme in the FFDCA that strictly limits the types of prescription drugs that are allowed to be introduced into domestic commerce. For example, the "American goods returned" provision (21 U.S.C. § 381(d)(1)) was enacted in 1988 as part of the federal Prescription Drug Marketing Act. PL. 100-293 (April 22, 1988). In enacting the law, Congress cited the explicit goal of limiting the flow of drugs into the United States from abroad. In section 2 of the bill, Congress found, "[l]large amounts of drugs are being reimported into the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping." Id . Clearly, Congress enacted section 381(d)(1) and the other import provisions in the FFDCA with the goal of controlling the types of drugs that could be legally imported into the United States . The federal scheme is comprehensive in that it promulgates national standards that are to be applied equally to all ports of entry, regardless of the states in which they are situated. By definition, the scheme cannot allow the individual states to enact laws that erode the federal standards; otherwise, importers could simply circumvent the federal law by routing all their unapproved drugs into the state (or states) that allowed such imports. Licensure of Canadian pharmacies by the state of Texas would be inconsistent with the plain objectives of the FFDCA if such licensure authorized those Canadian pharmacies to ship into the United States drugs that violate the provisions of the FFDCA.
I hope that the preceding discussion is helpful to you. The licensure of Canadian pharmacies by the Texas State Board of Pharmacy will not only result in violations of federal law, it may put citizens at risk. In our experience, many drugs obtained from foreign sources that purport and appear to be the same as FDA-approved prescription drugs have been of unknown quality and origin. FDA approves a drug based on scientific data submitted by the drug sponsor to demonstrate that the drug is safe and effective. We cannot provide adequate assurance to the American public that the drug products delivered to consumers in the United States from foreign countries are the same products approved by FDA. Accordingly, the FFDCA strictly limits the types of prescription drugs that may be imported into the United States . Any state law that legalizes imports in contravention of the FFDCA would be preempted by federal law. Moreover, those importing drugs in violation of the FFDCA would be subject to liability under that statute, regardless of whether the importation was otherwise sanctioned by the state.
We are aware that the high cost of some prescription drugs is a serious public health issue, and we have taken several steps in recent months to help reduce the cost of drugs in the United States without opening our borders to the potential dangers of foreign unapproved pharmaceuticals. These steps include new initiatives to accelerate approval of innovative medical procedures and drug therapies, changes to our regulations to reduce litigation that has been shown to delay unnecessarily access to more affordable generic drugs, and proposals to increase agency resources for the review and approval of generic drugs – products that are often far less expensive than brand name products in the U.S., and generally less expensive than the generic drugs sold elsewhere in the industrialized world. Also, the Medicare prescription drug discount card provides millions of America 's seniors with discounts and coverage for their prescription medicines.
Acting Associate Commissioner for Policy
1 We will limit our discussion to drugs imported from Canada because the Texas proposed bill is limited to Canada . The legal analysis is the same for drugs imported from any foreign country.