Vitamin D Crimin
Ellington Walford
WASHINGTON, D.C. -- Three Japanese pharmaceutical companiestoday agreed to plead guilty and pay fines totaling $137 millionfor participating in a worldwide conspiracy to raise and fixprices and allocate market shares for certain vitamins sold inthe United States and elsewhere, the Department of Justiceannounced.
Takeda Chemical Industries Ltd., of Osaka, Japan, will pleadguilty and pay a $72 million criminal fine for conspiring to fixthe price and allocate the sales of Vitamins B2 (Riboflavin) andC sold in the US and elsewhere. Eisai Co. Ltd., of Tokyo, Japan,will plead guilty and pay a $40 million criminal fine forconspiring to fix the price and allocate the sales of Vitamin Esold in the U.S. and elsewhere. Daiichi Pharmaceutical Co. Ltd.,also of Tokyo, will plead guilty and pay a $25 million fine forfixing the price and allocating the sales of Vitamin B5 (CalPan)sold in the U.S. and elsewhere. All three criminal cases werefiled today in U.S. District Court in Dallas.
Thus far, the Justice Department has brought 13 cases andobtained more than $850 million in criminal fines as a result ofan ongoing antitrust investigation of the worldwide vitaminindustry. Today's cases are the latest in a series ofinternational conspiracy cases filed by the Department'sAntitrust Division in the last several years.
All three of the companies charged today and many of theirexecutives are cooperating with the government's ongoinginvestigation of a long-term international cartel that fixed theprices at which vitamins were sold and allocated the sales ofvarious vitamins among the cartel members, the Justice Departmentsaid. In addition, Takeda is cooperating with the Department ofJustice in an investigation into the food flavor enhancersindustry, the Department said.
"The prosecution of these three Japanese companies furtherdemonstrates the truly international aspect of the vitaminsconspiracy," said Joel I. Klein, Assistant Attorney General incharge of the Department's Antitrust Division. "This conspiracyartificially inflated the cost to virtually every American ofsuch everyday necessities as milk, bread, orange juice, andcereal, which were fortified with the vitamins produced by theseconspirators. By conspiring to fix the price and allocate thesales of these vitamins, these companies and their co-conspirators reaped hundreds of millions of dollars in additionalrevenues."
Each of the three Japanese firms is charged withparticipating in price-fixing activities with their respectiveEuropean cartel partners beginning in early 1991. Takeda'sactivities ended in late 1995, while both Daiichi's and Eisai'scollusion continued into February 1999. The conduct engaged inby each of the companies included:
"The Antitrust Division has now prosecuted firms in thevitamin industry located on three continents, demonstrating onceagain the Division's resolve to punish illegal conspiracies thatharm American businesses and consumers regardless of the locationof the conspirators," said Gary R. Spratling, the AntitrustDivision's Deputy Assistant Attorney General for criminalenforcement.
Each of the companies in all three cases are charged withviolating the Sherman Act which carries a maximum fine of $10million for corporations. However, the maximum fine may beincreased to twice the gain derived from the crime or twice theloss suffered by the victims of the crime, if either of thoseamounts is greater than the statutory maximum fine.
The fines resulting from these prosecutions will bedeposited into the Crime Victims Fund, which is used to providefinancial compensation and direct services to victims of crimeand training and technical assistance for victim advocates,criminal justice and allied professionals across the country. The fund is supported by fines paid by federal criminaloffenders, not taxpayers, and is administered by the Office forVictims of Crime (O.V.C.).
Said chapter 118E of the General Laws, as appearing in the 2022 Official Edition, is hereby amended by adding the following 2 sections:-
Section 83. (a) As used in this section and section 84, the following terms shall have the following meaning unless the context clearly requires otherwise:
"HSN", the payment program established and administered in accordance with sections 8A and 64 through 69, inclusive.
"HSN patient", an individual served by an HSN provider whose services are paid for through the HSN.
"OTC oral contraceptive", a nonprescription oral contraceptive approved or otherwise authorized by the federal Food and Drug Administration.
(b) Notwithstanding any general or special law to the contrary, a physician who is registered to prescribe or dispense a controlled substance in the course of professional practice under section 7 of chapter 94C and is designated by the assistant secretary for the division may issue a standing order that may be used for a licensed pharmacist to dispense an OTC oral contraceptive to a MassHealth member or HSN patient.
(c) Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense an OTC oral contraceptive in accordance with the standing order issued under subsection (b) to a MassHealth member or HSN patient. Except for an act of gross negligence or willful misconduct, a pharmacist who, acting in good faith, dispenses an OTC oral contraceptive consistent with the standing order shall not be subject to any criminal or civil liability or any professional disciplinary action by the board of registration in pharmacy related to the use of an OTC oral contraceptive.
(d) A pharmacist who dispenses an OTC oral contraceptive pursuant to this section to a MassHealth member or HSN patient shall submit a claim to MassHealth or the HSN, as applicable.
(e) Except for an act of gross negligence or willful misconduct, the assistant secretary for the division or a physician who issues the standing order under subsection (b) and any practitioner who, acting in good faith, directly or through the standing order, prescribes or dispenses an OTC oral contraceptive to a MassHealth member or HSN patient shall not be subject to any criminal or civil liability or any professional disciplinary action.
(f) The division may adopt regulations or issue written guidance to implement this section.
Section 84. (a) As used in this section, the following terms shall have the following meaning unless the context clearly requires otherwise:
"Prenatal vitamin", an oral multivitamin for supporting health during pregnancy.
(b) Notwithstanding any general or special law to the contrary, a physician who is registered to prescribe or dispense a controlled substance in the course of professional practice under section 7 of chapter 94C and is designated by the assistant secretary for the division may issue a standing order that may be used for a licensed pharmacist to dispense a prenatal vitamin to a MassHealth member or HSN patient.
(c) Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense a prenatal vitamin in accordance with the standing order issued under subsection (b) to a MassHealth member or HSN patient. Except for an act of gross negligence or willful misconduct, a pharmacist who, acting in good faith, dispenses a prenatal vitamin consistent with the standing order shall not be subject to any criminal or civil liability or any professional disciplinary action by the board of registration in pharmacy related to the use of a prenatal vitamin.
(d) A pharmacist who dispenses a prenatal vitamin pursuant to this section to a MassHealth member or HSN patient shall submit a claim to MassHealth or the HSN, as applicable.
(e) Except for an act of gross negligence or willful misconduct, the assistant secretary for the division or a physician who issues the standing order under subsection (b) and any practitioner who, acting in good faith, directly or through the standing order, prescribes or dispenses a prenatal vitamin to a MassHealth member or HSN patient shall not be subject to any criminal or civil liability or any professional disciplinary action.
(f) The division may adopt regulations or issue written guidance to implement this section.
This section establishes standing orders for prenatal vitamins and oral contraceptives so that Federal Financial Participation is available for these products when pharmacists dispense them to MassHealth members and to individuals whose claims are paid by the Health Safety Net.
Note: These are reference values for normal, apparently healthy individuals eating a typical mixed North American diet. An individual may have physiological, health, or lifestyle characteristics that may require tailoring of specific nutrient values.
The UL for folate applies only to synthetic forms obtained from supplements, fortified foods, or a combination of the two. The UL values are expressed as micrograms of folic acid, not micrograms of DFEs.
Although AIs have been set for choline, there are few data to assess whether a dietary supply of choline is needed at all stages of the life cycle, and it may be that the choline requirement can be met by endogenous synthesis at some of these stages.
In view of evidence linking the use of supplements containing folic acid before conception and during early pregnancy with reduced risk of neural tube defects in the fetus, it is recommended that all women capable of becoming pregnant consume 400 μg of folic acid every day, in addition to intake of food folate from a varied diet.
It is assumed that women will continue consuming 400 μg folic acid from supplements until their pregnancy is confirmed and they enter prenatal care. The critical time for formation of the neural tube is within four weeks after conception.
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