Originally published May 7 2007
28 Senators vote to maintain Big Pharma monopoly over U.S. consumers; Republicans oppose free trade for medicine
by Mike Adams, the Health Ranger, NaturalNews Editor
On May 3rd, 2007, U.S. Senators voted on an amendment to the 2007 Prescription Drug User Fee bill that aims to reform the FDA and enhance drug safety. This amendment, known as the "Dorgan Amendment No. 990," threatened to break Big Pharma's monopoly over pharmaceutical sales and allow U.S. consumers, cities, states and businesses to purchase their pharmaceuticals from safety-certified pharmacies located in Canada, Japan, the U.K. and other nations.
Americans currently pay the highest prices in the world for prescription drugs. Canadians, Europeans, and even citizens of Mexico pay only about one-half to as little as one-tenth the price paid by Americans for the very same chemicals. Drug companies actually import many of the raw materials used in pharmaceuticals from other countries, meaning that some U.S. medicines are already sourced from countries like the U.K. and Germany.
Drug companies mark up their prescription drugs as much as 569,000% over the price of the raw materials. (A typical markup is more in the 30,000% - 50,000% range.) Retailing pharmaceuticals is hugely profitable. There is no business in the world with more profit built in to the retail price of the product. The purpose of restricting Americans from buying drugs from other countries is to enforce a medical monopoly in the United States, forcing consumers to purchase drugs at the highest prices in the world, further padding the profits of powerful and influential pharmaceutical corporations who exert strong influence over the Bush Administration and Republican lawmakers.
The FDA has, over the past several years, colluded with drug companies to maintain a monopoly market in the United States in order to protect those profits. It has taken actions such as raiding a bus load of senior citizens returning to the U.S. from Canada, searching the elderly for legal drugs. The FDA has gone to great lengths to pressure U.S. customs to seize pharmaceutical shipments being imported for sale to individual consumers in the United States, and it has even invoked the fantasy-based fear tactic of suggesting that terrorists might adulterate pharmaceuticals coming to the U.S. from Canada (and therefore we should all buy our drugs only from U.S. monopoly-controlled pharmacies because of "terrorists").
Dorgan amendment proposes free trade for medicine
The Dorgan amendment, entitled, "Pharmaceutical Market Access and Drug Safety Act of 2007," proposes what is essentially a free trade policy on prescription medications. It would allow Americans to buy their drugs from certain certified organizations registered as valid importers or exporters. The bill states, "...a prescription drug is neither safe nor effective to an individual who cannot afford it," and goes on to describe rigorous safety requirements that would be required by the amendment, including safety inspections and registrations as well as funding efforts to locate and shut down fraudulent internet sales of counterfeit prescription drugs.
If passed into the law, this amendment would save U.S. citizens, businesses, and government entities (local, state and federal) billions of dollars each year by allowing them to source medications in a price competitive environment. Many cities and states are right now facing the very real possibility of bankruptcy due to health care costs (providing benefits to current and former government employees). A large percentage of those costs are spent on monopoly-priced pharmaceuticals. This Dorgan amendment would set city and state governments free to finally engage in fundamental free market price comparisons and save substantial sums of money in sourcing the very same chemical medications for their employees and retirees.
28 Republicans voted against the Dorgan amendment, voting to enforce the pharmaceutical monopoly and keep Big Pharma in control of virtually the entire U.S. medication market. There were no Democrats that voted against the amendment. But why would 28 Republican Senators vote against breaking a marketplace monopoly and encouraging the use of free market economics to save American consumers billions of dollars? The answer isn't complicated: Because nearly all of them have taken money from pharmaceutical companies!
The Big Pharma 28
Here's the list of the 28 Senators who voted to protect Big Pharma's monopoly:
Alexander (R-TN)
Allard (R-CO)
Bennett (R-UT)
Bond (R-MO)
Bunning (R-KY)
Burr (R-NC)
Chambliss (R-GA)
Cochran (R-MS)
Cornyn (R-TX)
Crapo (R-ID)
Dole (R-NC)
Domenici (R-NM)
Ensign (R-NV)
Enzi (R-WY)
Gregg (R-NH)
Hagel (R-NE)
Hutchison (R-TX)
Inhofe (R-OK)
Isakson (R-GA)
Kyl (R-AZ)
Lugar (R-IN)
McConnell (R-KY)
Murkowski (R-AK)
Roberts (R-KS)
Stevens (R-AK)
Sununu (R-NH)
Thomas (R-WY)
Voinovich (R-OH)
These Senators cite "safety concerns" as a reason for enforcing a U.S. monopoly on prescription drugs and allowing Big Pharma to bilk Americans out of billions of dollars by operating an obvious profiteering scheme. But the truth is that the price you pay for a drug does not affect its safety. And those concerned that adulterated medications from other countries might harm patients conveniently forget that FDA-approved drugs sold in the United States already kill 100,000 Americans each year. It would be difficult to find any source more dangerous than the pharmacies operating in the U.S. right now.
Medications are universally dangerous because they are made from synthetic chemicals that simply do not belong in the human body. Every drug has unintended side effects which include nutritional deficiencies, biochemical imbalances, liver damage, heart damage and even death. Vioxx alone -- which was approved by the FDA and heavily pushed by drug company advertising -- reportedly killed well over 50,000 Americans according to the FDA's own senior drug safety scientist Dr. David Graham. The idea that prescription drugs are safe is ludicrous, and trying to "ensure drug safety" by forcing Americans to pay the highest prices in the world for dangerous synthetic chemicals is a logical fallacy and nothing more than a thinly veiled attempt to protect the profiteering drug racket while claiming to be protecting the public.
President Bush has promised to veto the bill if the Dorgan amendment stands. Free trade for medicine simply will not be tolerated in the United States. There's too much money at stake.
62 Senators supported the amendment
Here's the list of the 63 Senators who voted in favor of the Dorgan amendment and, hence, free trade for medicines:
Akaka (D-HI)
Baucus (D-MT)
Bayh (D-IN)
Boxer (D-CA)
Brown (D-OH)
Byrd (D-WV)
Cantwell (D-WA)
Cardin (D-MD)
Carper (D-DE)
Casey (D-PA)
Clinton (D-NY)
Coburn (R-OK)
Coleman (R-MN)
Collins (R-ME)
Conrad (D-ND)
Corker (R-TN)
Craig (R-ID)
DeMint (R-SC)
Dorgan (D-ND)
Durbin (D-IL)
Feingold (D-WI)
Feinstein (D-CA)
Grassley (R-IA)
Harkin (D-IA)
Inouye (D-HI)
Kennedy (D-MA)
Kerry (D-MA)
Klobuchar (D-MN)
Kohl (D-WI)
Landrieu (D-LA)
Lautenberg (D-NJ)
Leahy (D-VT)
Levin (D-MI)
Lieberman (ID-CT)
Lincoln (D-AR)
Lott (R-MS)
Martinez (R-FL)
McCaskill (D-MO)
Menendez (D-NJ)
Mikulski (D-MD)
Murray (D-WA)
Nelson (D-FL)
Nelson (D-NE)
Obama (D-IL)
Pryor (D-AR)
Reed (D-RI)
Reid (D-NV)
Rockefeller (D-WV)
Salazar (D-CO)
Sanders (I-VT)
Schumer (D-NY)
Sessions (R-AL)
Shelby (R-AL)
Smith (R-OR)
Snowe (R-ME)
Specter (R-PA)
Stabenow (D-MI)
Tester (D-MT)
Thune (R-SD)
Vitter (R-LA)
Webb (D-VA)
Whitehouse (D-RI)
Wyden (D-OR)
Nine Senators did not vote
Biden (D-DE)
Bingaman (D-NM)
Brownback (R-KS)
Dodd (D-CT)
Graham (R-SC)
Hatch (R-UT)
Johnson (D-SD)
McCain (R-AZ)
Warner (R-VA)
Text of the Dorgan amendment
What follows is the partial text of the Dorgan amendment as printed in the Congressional Record for the Senate. The remainder of the text can be found by clicking here.
SA 990. Mr. DORGAN (for himself, Ms. Snowe, Mr. Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows:
At the appropriate place, insert the following:
TITLE __--IMPORTATION OF PRESCRIPTION DRUGS
SEC. X01. SHORT TITLE.
This title may be cited as the Pharmaceutical Market Access and Drug Safety Act of 2007''.
SEC. X02. FINDINGS.
Congress finds that--
(1) Americans unjustly pay up to 5 times more to fill their prescriptions than consumers in other countries;
(2) the United States is the largest market for pharmaceuticals in the world, yet American consumers pay the highest prices for brand pharmaceuticals in the world;
(3) a prescription drug is neither safe nor effective to an individual who cannot afford it;
(4) allowing and structuring the importation of prescription drugs to ensure access to safe and affordable drugs approved by the Food and Drug Administration will provide a level of safety to American consumers that they do not currently enjoy;
(5) American spend more than $200,000,000,000 on prescription drugs every year;
(6) the Congressional Budget Office has found that the cost of prescription drugs are between 35 to 55 percent less in other highly-developed countries than in the United States; and
(7) promoting competitive market pricing would both contribute to health care savings and allow greater access to therapy, improving health and saving lives.
SEC. X03. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF PRESCRIPTION DRUGS.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804.
SEC. X04. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT RESTRICTIONS.
(a) In General.--Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section X03, is further amended by inserting after section 803 the following:
SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.
(a) Importation of Prescription Drugs.--
(1) IN GENERAL.--In the case of qualifying drugs imported or offered for import into the United States from registered exporters or by registered importers--
(A) the limitation on importation that is established in section 801(d)(1) is waived; and
(B) the standards referred to in section 801(a) regarding admission of the drugs are subject to subsection (g) of this section (including with respect to qualifying drugs to which section 801(d)(1) does not apply).
(2) IMPORTERS.--A qualifying drug may not be imported under paragraph (1) unless--
(A) the drug is imported by a pharmacy, group of pharmacies, or a wholesaler that is a registered importer; or
(B) the drug is imported by an individual for personal use or for the use of a family member of the individual (not for resale) from a registered exporter.
(3) RULE OF CONSTRUCTION.--This section shall apply only with respect to a drug that is imported or offered for import into the United States--
(A) by a registered importer; or
(B) from a registered exporter to an individual.
(4) DEFINITIONS.--
(A) REGISTERED EXPORTER; REGISTERED IMPORTER.--For purposes of this section:
(i) The term 'registered exporter' means an exporter for which a registration under subsection (b) has been approved and is in effect.
(ii) The term 'registered importer' means a pharmacy, group of pharmacies, or a wholesaler for which a registration under subsection (b) has been approved and is in effect.
(iii) The term 'registration condition' means a condition that must exist for a registration under subsection (b) to be approved.
(B) QUALIFYING DRUG.--For purposes of this section, the term 'qualifying drug' means a drug for which there is a corresponding U.S. label drug.
(C) U.S. LABEL DRUG.--For purposes of this section, the term 'U.S. label drug' means a prescription drug that--
(i) with respect to a qualifying drug, has the same active ingredient or ingredients, route of administration, dosage form, and strength as the qualifying drug;
(ii) with respect to the qualifying drug, is manufactured by or for the person that manufactures the qualifying drug;
(iii) is approved under section 505(c); and
(iv) is not--
(I) a controlled substance, as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802);
(II) a biological product, as defined in section 351 of the Public Health Service Act (42 U.S.C. 262), including--
(aa) a therapeutic DNA plasmid product;
(bb) a therapeutic synthetic peptide product;
(cc) a monoclonal antibody product for in vivo use; and
(dd) a therapeutic recombinant DNA-derived product;
(III) an infused drug, including a peritoneal dialysis solution;
(IV) an injected drug;
(V) a drug that is inhaled during surgery;
(VI) a drug that is the listed drug referred to in 2 or more abbreviated new drug applications under which the drug is commercially marketed; or
(VII) a sterile opthlamic drug intended for topical use on or in the eye.
(D) OTHER DEFINITIONS.--For purposes of this section:
(i)(I) The term 'exporter' means a person that is in the business of exporting a drug to individuals in the United States from Canada or from a permitted country designated by the Secretary under subclause (II), or that, pursuant to submitting a registration under subsection (b), seeks to be in such business.
(II) The Secretary shall designate a permitted country under subparagraph (E) (other than Canada) as a country from which an exporter may export a drug to individuals in the United States if the Secretary determines that--
(aa) the country has statutory or regulatory standards that are equivalent to the standards in the United States and Canada with respect to--
(AA) the training of pharmacists;
(BB) the practice of pharmacy; and
(CC) the protection of the privacy of personal medical information; and
(bb) the importation of drugs to individuals in the United States from the country will not adversely affect public health.
(ii) The term 'importer' means a pharmacy, a group of pharmacies, or a wholesaler that is in the business of importing a drug into the United States or that, pursuant to submitting a registration under subsection (b), seeks to be in such business.
(iii) The term 'pharmacist' means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs.
(iv) The term 'pharmacy' means a person that--
(I) is licensed by a State to engage in the business of selling prescription drugs at retail; and
(II) employs 1 or more pharmacists.
(v) The term 'prescription drug' means a drug that is described in section 503(b)(1).
(vi) The term 'wholesaler'--
(I) means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 503(e)(2)(A); and
(II) does not include a person authorized to import drugs under section 801(d)(1).
(E) PERMITTED COUNTRY.--The term 'permitted country' means--
(i) Australia;
(ii) Canada;
(iii) a member country of the European Union, but does not include a member country with respect to which--
(I) the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired; or
(II) the Secretary determines that the requirements described in subclauses (I) and (II) of clause (vii) will not be met by the date on which such transitional measure for the regulation of human pharmaceutical products expires;
(iv) Japan;
(v) New Zealand;
(vi) Switzerland; and
(vii) a country in which the Secretary determines the following requirements are met:
(I) The country has statutory or regulatory requirements--
(aa) that require the review of drugs for safety and effectiveness by an entity of the government of the country;
(bb) that authorize the approval of only those drugs that have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs;
(cc) that require the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country to be adequate to preserve their identity, quality, purity, and strength;
(dd) for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective; and
(ee) that require the labeling and promotion of drugs to be in accordance with the approval of the drug.
(II) The valid marketing authorization system in the country is equivalent to the systems in the countries described in clauses (i) through (vi).
(III) The importation of drugs to the United States from the country will not adversely affect public health.
(b) Registration of Importers and Exporters.--
(1) REGISTRATION OF IMPORTERS AND EXPORTERS.--A registration condition is that the importer or exporter involved (referred to in this subsection as a 'registrant') submits to the Secretary a registration containing the following:
(A)(i) In the case of an exporter, the name of the exporter and an identification of all places of business of the exporter that relate to qualifying drugs, including each warehouse or other facility owned or controlled by, or operated for, the exporter.
(ii) In the case of an importer, the name of the importer and an identification of the places of business of the importer at which the importer initially receives a qualifying drug after importation (which shall not exceed 3 places of business except by permission of the Secretary).
(B) Such information as the Secretary determines to be necessary to demonstrate that the registrant is in compliance with registration conditions under--
(i) in the case of an importer, subsections (c), (d), (e), (g), and (j) (relating to the sources of imported qualifying drugs; the inspection of facilities of the importer; the payment of fees; compliance with the standards referred to in section 801(a); and maintenance of records and samples); or
(ii) in the case of an exporter, subsections (c), (d), (f), (g), (h), (i), and (j) (relating to the sources of exported qualifying drugs; the inspection of facilities of the exporter and the marking of compliant shipments; the payment of fees; and compliance with the standards referred to in section 801(a); being licensed as a pharmacist; conditions for individual importation; and maintenance of records and samples).
(C) An agreement by the registrant that the registrant will not under subsection (a) import or export any drug that is not a qualifying drug.
(D) An agreement by the registrant to--
(i) notify the Secretary of a recall or withdrawal of a qualifying drug distributed in a permitted country that the registrant has exported or imported, or intends to export or import, to the United States under subsection (a);
(ii) provide for the return to the registrant of such drug; and
(iii) cease, or not begin, the exportation or importation of such drug unless the Secretary has notified the registrant that exportation or importation of such drug may proceed.
(E) An agreement by the registrant to ensure and monitor compliance with each registration condition, to promptly correct any noncompliance with such a condition, and to promptly report to the Secretary any such noncompliance.
(F) A plan describing the manner in which the registrant will comply with the agreement under subparagraph (E).
(G) An agreement by the registrant to enforce a contract under subsection (c)(3)(B) against a party in the chain of custody of a qualifying drug with respect to the authority of the Secretary under clauses (ii) and (iii) of that subsection.
(H) An agreement by the registrant to notify the Secretary not more than 30 days before the registrant intends to make the change, of--
(i) any change that the registrant intends to make regarding information provided under subparagraph (A) or (B); and
(ii) any change that the registrant intends to make in the compliance plan under subparagraph (F).
(I) In the case of an exporter--
(i) An agreement by the exporter that a qualifying drug will not under subsection (a) be exported to any individual not authorized pursuant to subsection (a)(2)(B) to be an importer of such drug.
(ii) An agreement to post a bond, payable to the Treasury of the United States that is equal in value to the lesser of--
(I) the value of drugs exported by the exporter to the United States in a typical 4-week period over the course of a year under this section; or
(II) $1,000,000;
(iii) An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B).
(iv) An agreement by the exporter to report to the Secretary--
(I) not later than August 1 of each fiscal year, the total price and the total volume of drugs exported to the United States by the exporter during the 6-month period from January 1 through June 30 of that year; and
(II) not later than January 1 of each fiscal year, the total price and the total volume of drugs exported to the United States by the exporter during the previous fiscal year.
(J) In the case of an importer, an agreement by the importer to report to the Secretary--
(i) not later than August 1 of each fiscal year, the total price and the total volume of drugs imported to the United States by the importer during the 6-month period from January 1 through June 30 of that fiscal year; and
(ii) not later than January 1 of each fiscal year, the total price and the total volume of drugs imported to the United States by the importer during the previous fiscal year.
(K) Such other provisions as the Secretary may require by regulation to protect the public health while permitting--
(i) the importation by pharmacies, groups of pharmacies, and wholesalers as registered importers of qualifying drugs under subsection (a); and
(ii) importation by individuals of qualifying drugs under subsection (a).
(2) APPROVAL OR DISAPPROVAL OF REGISTRATION.--
(A) IN GENERAL.--Not later than 90 days after the date on which a registrant submits to the Secretary a registration under paragraph (1), the Secretary shall notify the registrant whether the registration is approved or is disapproved. The Secretary shall disapprove a registration if there is reason to believe that the registrant is not in compliance with one or more registration conditions, and shall notify the registrant of such reason. In the case of a disapproved registration, the
Secretary shall subsequently notify the registrant that the registration is approved if the Secretary determines that the registrant is in compliance with such conditions.
(B) CHANGES IN REGISTRATION INFORMATION.--Not later than 30 days after receiving a notice under paragraph (1)(H) from a registrant, the Secretary shall determine whether the change involved affects the approval of the registration of the registrant under paragraph (1), and shall inform the registrant of the determination.
(3) PUBLICATION OF CONTACT INFORMATION FOR REGISTERED EXPORTERS.--Through the Internet website of the Food and Drug Administration and a toll-free telephone number, the Secretary shall make readily available to the public a list of registered exporters, including contact information for the exporters. Promptly after the approval of a registration submitted under paragraph (1), the Secretary shall update the Internet website and the information provided through the toll-free telephone
number accordingly.
(4) SUSPENSION AND TERMINATION.--
(A) SUSPENSION.--With respect to the effectiveness of a registration submitted under paragraph (1):
(i) Subject to clause (ii), the Secretary may suspend the registration if the Secretary determines, after notice and opportunity for a hearing, that the registrant has failed to maintain substantial compliance with a registration condition.
(ii) If the Secretary determines that, under color of the registration, the exporter has exported a drug or the importer has imported a drug that is not a qualifying drug, or a drug that does not comply with subsection (g)(2)(A) or (g)(4), or has exported a qualifying drug to an individual in violation of subsection (i)(2)(F), the Secretary shall immediately suspend the registration. A suspension under the preceding sentence is not subject to the provision by the Secretary of prior notice,
and the Secretary shall provide to the registrant an opportunity for a hearing not later than 10 days after the date on which the registration is suspended.
(iii) The Secretary may reinstate the registration, whether suspended under clause (i) or (ii), if the Secretary determines that the registrant has demonstrated that further violations of registration conditions will not occur.
(B) TERMINATION.--The Secretary, after notice and opportunity for a hearing, may terminate the registration under paragraph (1) of a registrant if the Secretary determines that the registrant has engaged in a pattern or practice of violating 1 or more registration conditions, or if on 1 or more occasions the Secretary has under subparagraph (A)(ii) suspended the registration of the registrant. The Secretary may make the termination permanent, or for a fixed period of not less than 1
year. During the period in which the registration is terminated, any registration submitted under paragraph (1) by the registrant, or a person that is a partner in the export or import enterprise, or a principal officer in such enterprise, and any registration prepared with the assistance of the registrant or such a person, has no legal effect under this section.
(5) DEFAULT OF BOND.--A bond required to be posted by an exporter under paragraph (1)(I)(ii) shall be defaulted and paid to the Treasury of the United States if, after opportunity for an informal hearing, the Secretary determines that the exporter has--
(A) exported a drug to the United States that is not a qualifying drug or that is not in compliance with subsection (g)(2)(A), (g)(4), or (i); or
(B) failed to permit the Secretary to conduct an inspection described under subsection (d).
(c) Sources of Qualifying Drugs.--A registration condition is that the exporter or importer involved agrees that a qualifying drug will under subsection (a) be exported or imported into the United States only if there is compliance with the following:
(1) The drug was manufactured in an establishment--
(A) required to register under subsection (h) or (i) of section 510; and
(B)(i) inspected by the Secretary; or
(ii) for which the Secretary has elected to rely on a satisfactory report of a good manufacturing practice inspection of the establishment from a permitted country whose regulatory system the Secretary recognizes as equivalent under a mutual recognition agreement, as provided for under section 510(i)(3), section 803, or part 26 of title 21, Code of Federal Regulations (or any corresponding successor rule or regulation).
(2) The establishment is located in any country, and the establishment manufactured the drug for distribution in the United States or for distribution in 1 or more of the permitted countries (without regard to whether in addition the drug is manufactured for distribution in a foreign country that is not a permitted country).
(3) The exporter or importer obtained the drug--
(A) directly from the establishment; or
(B) directly from an entity that, by contract with the exporter or importer--
(i) provides to the exporter or importer a statement (in such form and containing such information as the Secretary may require) that, for the chain of custody from the establishment, identifies each prior sale, purchase, or trade of the drug (including the date of the transaction and the names and addresses of all parties to the transaction);
(ii) agrees to permit the Secretary to inspect such statements and related records to determine their accuracy;
(iii) agrees, with respect to the qualifying drugs involved, to permit the Secretary to inspect warehouses and other facilities, including records, of the entity for purposes of determining whether the facilities are in compliance with any standards under this Act that are applicable to facilities of that type in the United States; and
(iv) has ensured, through such contractual relationships as may be necessary, that the Secretary has the same authority regarding other parties in the chain of custody from the establishment that the Secretary has under clauses (ii) and (iii) regarding such entity.
(4)(A) The foreign country from which the importer will import the drug is a permitted country; or
(B) The foreign country from which the exporter will export the drug is the permitted country in which the exporter is located.
(5) During any period in which the drug was not in the control of the manufacturer of the drug, the drug did not enter any country that is not a permitted country.
(6) The exporter or importer retains a sample of each lot of the drug for testing by the Secretary.
(d) Inspection of Facilities; Marking of Shipments.--
(1) INSPECTION OF FACILITIES.--A registration condition is that, for the purpose of assisting the Secretary in determining whether the exporter involved is in compliance with all other registration conditions--
(A) the exporter agrees to permit the Secretary--
(i) to conduct onsite inspections, including monitoring on a day-to-day basis, of places of business of the exporter that relate to qualifying drugs, including each warehouse or other facility owned or controlled by, or operated for, the exporter;
(ii) to have access, including on a day-to-day basis, to--
(I) records of the exporter that relate to the export of such drugs, including financial records; and
(II) samples of such drugs;
(iii) to carry out the duties described in paragraph (3); and
(iv) to carry out any other functions determined by the Secretary to be necessary regarding the compliance of the exporter; and
(B) the Secretary has assigned 1 or more employees of the Secretary to carry out the functions described in this subsection for the Secretary randomly, but not less than 12 times annually, on the premises of places of businesses referred to in subparagraph (A)(i), and such an assignment remains in effect on a continuous basis.
(2) MARKING OF COMPLIANT SHIPMENTS.--A registration condition is that the exporter involved agrees to affix to each shipping container of qualifying drugs exported under subsection (a) such markings as the Secretary determines to be necessary to identify the shipment as being in compliance with all registration conditions. Markings under the preceding sentence shall--
(A) be designed to prevent affixation of the markings to any shipping container that is not authorized to bear the markings; and
(B) include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies.
(3) CERTAIN DUTIES RELATING TO EXPORTERS.--Duties of the Secretary with respect to an exporter include the following:
(A) Inspecting, randomly, but not less than 12 times annually, the places of business of the exporter at which qualifying drugs are stored and from which qualifying drugs are shipped.
(B) During the inspections under subparagraph (A), verifying the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the exporter, which shall be accomplished or supplemented by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except that a drug that lacks such technologies from the point of manufacture shall not
for that reason be excluded from importation by an exporter.
(C) Randomly reviewing records of exports to individuals for the purpose of determining whether the drugs are being imported by the individuals in accordance with the conditions under subsection (i). Such reviews shall be conducted in a manner that will result in a statistically significant determination of compliance with all such conditions.
(D) Monitoring the affixing of markings under paragraph (2).
(E) Inspecting as the Secretary determines is necessary the warehouses and other facilities, including records, of other parties in the chain of custody of qualifying drugs.
(F) Determining whether the exporter is in compliance with all other registration conditions.
(4) PRIOR NOTICE OF SHIPMENTS.--A registration condition is that, not less than 8 hours and not more than 5 days in advance of the time of the importation of a shipment of qualifying drugs, the importer involved agrees to submit to the Secretary a notice with respect to the shipment of drugs to be imported or offered for import into the United States under subsection (a). A notice under the preceding sentence shall include--
(A) the name and complete contact information of the person submitting the notice;
(B) the name and complete contact information of the importer involved;
(C) the identity of the drug, including the established name of the drug, the quantity of the drug, and the lot number assigned by the manufacturer;
(D) the identity of the manufacturer of the drug, including the identity of the establishment at which the drug was manufactured;
(E) the country from which the drug is shipped;
(F) the name and complete contact information for the shipper of the drug;
(G) anticipated arrival information, including the port of arrival and crossing location within that port, and the date and time;
(H) a summary of the chain of custody of the drug from the establishment in which the drug was manufactured to the importer;
(I) a declaration as to whether the Secretary has ordered that importation of the drug from the permitted country cease under subsection (g)(2)(C) or (D); and
(J) such other information as the Secretary may require by regulation.
(5) MARKING OF COMPLIANT SHIPMENTS.--A registration condition is that the importer involved agrees, before wholesale distribution (as defined in section 503(e)) of a qualifying drug that has been imported under subsection (a), to affix to each container of such drug such markings or other technology as the Secretary determines necessary to identify the shipment as being in compliance with all registration conditions, except that the markings or other technology shall not be required
on a drug that bears comparable, compatible markings or technology from the manufacturer of the drug. Markings or other technology under the preceding sentence shall--
(A) be designed to prevent affixation of the markings or other technology to any container that is not authorized to bear the markings; and
(B) shall include anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of such technologies.
(6) CERTAIN DUTIES RELATING TO IMPORTERS.--Duties of the Secretary with respect to an importer include the following:
(A) Inspecting, randomly, but not less than 12 times annually, the places of business of the importer at which a qualifying drug is initially received after importation.
(B) During the inspections under subparagraph (A), verifying the chain of custody of a statistically significant sample of qualifying drugs from the establishment in which the drug was manufactured to the importer, which shall be accomplished or supplemented by the use of anticounterfeiting or track-and-trace technologies, taking into account the economic and technical feasibility of those technologies, except that a drug that lacks such technologies from the point of manufacture shall not
for that reason be excluded from importation by an importer.
(C) Reviewing notices under paragraph (4).
(D) Inspecting as the Secretary determines is necessary the warehouses and other facilities, including records of other parties in the chain of custody of qualifying drugs.
(E) Determining whether the importer is in compliance with all other registration conditions.
(e) Importer Fees.--
(1) REGISTRATION FEE.--A registration condition is that the importer involved pays to the Secretary a fee of $10,000 due on the date on which the importer first submits the registration to the Secretary under subsection (b).
(2) INSPECTION FEE.--A registration condition is that the importer involved pays a fee to the Secretary in accordance with this subsection. Such fee shall be paid not later than October 1 and April 1 of each fiscal year in the amount provided for under paragraph (3).
(3) AMOUNT OF INSPECTION FEE.--
(A) AGGREGATE TOTAL OF FEES.--Not later than 30 days before the start of each fiscal year, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of the Treasury, shall establish an aggregate total of fees to be collected under paragraph (2) for importers for that fiscal year that is sufficient, and not more than necessary, to pay the costs for that fiscal year of administering this section with respect to registered importers, including the costs associated
with--
(i) inspecting the facilities of registered importers, and of other entities in the chain of custody of a qualifying drug as necessary, under subsection (d)(6);
(ii) developing, implementing, and operating under such subsection an electronic system for submission and review of the notices required under subsection (d)(4) with respect to shipments of qualifying drugs under subsection (a) to assess compliance with all registration conditions when such shipments are offered for import into the United States; and
(iii) inspecting such shipments as necessary, when offered for import into the United States to determine if such a shipment should be refused admission under subsection (g)(5).
(B) LIMITATION.--Subject to subparagraph (C), the aggregate total of fees collected under paragraph (2) for a fiscal year shall not exceed 2.5 percent of the total price of qualifying drugs imported during that fiscal year into the United States by registered importers under subsection (a).
(C) TOTAL PRICE OF DRUGS.--
(i) ESTIMATE.--For the purposes of complying with the limitation described in subparagraph (B) when establishing under subparagraph (A) the aggregate total of fees to be collected under paragraph (2) for a fiscal year, the Secretary shall estimate the total price of qualifying drugs imported into the United States by registered importers during that fiscal year by adding the total price of qualifying drugs imported by each registered importer during the 6-month period from January 1
through June 30 of the previous fiscal year, as reported to the Secretary by each registered importer under subsection (b)(1)(J).
(ii) CALCULATION.--Not later than March 1 of the fiscal year that follows the fiscal year for which the estimate under clause (i) is made, the Secretary shall calculate the total price of qualifying drugs imported into the United States by registered importers during that fiscal year by adding the total price of qualifying drugs imported by each registered importer during that fiscal year, as reported to the Secretary by each registered importer under subsection (b)(1)(J).
(iii) ADJUSTMENT.--If the total price of qualifying drugs imported into the United States by registered importers during a fiscal year as calculated under clause (ii) is less than the aggregate total of fees collected under paragraph (2) for that fiscal year, the Secretary shall provide for a pro-rata reduction in the fee due from each registered importer on April 1 of the subsequent fiscal year so that the limitation described in subparagraph (B) is observed.
(D) INDIVIDUAL IMPORTER FEE.--Subject to the limitation described in subparagraph (B), the fee under paragraph (2) to be paid on October 1 and April 1 by an importer shall be an amount that is proportional to a reasonable estimate by the Secretary of the semiannual share of the importer of the volume of qualifying drugs imported by importers under subsection (a).
... full text continues at www.Govtrack.us
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