UK Takes First Step Toward ‘Designer Babies’

On February 3, 2015, Members of Parliament (MPs) in the United Kingdom (UK) debated and passed (by a vote of 382 to 128) a statutory instrument to approve the draft Human Fertilization and Embryology (Mitochondrial Donation) Regulations 2015 in the House of Commons.  Mitochondrial donation is also know as three-parent in vitro fertilization, which effectively allows the conception of babies from three people. Some people fear it is the first step toward creating designer babies, where genetic characteristics could be chosen by the parents. Researchers hope that mitochondrial donation will prevent the passage of mitochondrial diseases from mother to child.

According to a House of Commons research briefing, the mitochondrial donation techniques have been subject to three scientific reviews (2011, 2013 and a further update in 2014) by a Human Embryology and Fertilization Authority (HFEA) expert panel, an ethical review by the Nuffield Council on Bioethics and a HFEA public consultation. The statutory instrument must still be approved by the House of Lords before it becomes law. 

According to the Centers for Disease Control and Prevention (CDC), mitochondria are tiny parts of almost every cell in our bodies. They turn sugar and oxygen into energy that the cells need to work. In mitochondrial diseases, the mitochondria cannot efficiently turn sugar and oxygen into energy, so the cells do not work correctly. There are many types of mitochondrial disease, and they can affect the brain, kidneys, muscles, heart, eyes, ears, and other parts of the body.

To prevent the passage of mitochondrial disorders from mother to child, researchers have devised the mitochondrial donation process by which the nucleus of a woman carrying harmful mutations in her mitochondrial DNA is transferred to an enucleated egg (an egg with the nucleus surgically removed) of another woman without such defects. The hybrid egg, which carries the nuclear DNA of the mother-to-be and healthy mitochondria from the egg donor, can then be fertilized in vitro with sperm from the would-be father, and the resulting embryos implanted into the mother-to-be.

The BBC reported that the Church of England and the Catholic Church in England and Wales urged UK politicians to delay their decision in order to allow more research and debate. The BBC quotes the Reverend Doctor Brendan McCarthy, Church of England advisor on medical ethics, as saying “We need to be absolutely clear that the techniques that will be used will be safe, and we need to be absolutely sure that they will work.” Sharon Bernardi, who lost all of her seven children to mitochondrial disease, told the BBC that this was not about changing the color of a child’s eyes. “This is [about] trying to make children survive,” she said. “We are not playing God or anything. I would ask them [the Church of England] desperately to please look at the bigger picture and look at the children who have been affected by the dreadful disease. No child should be born with a disease that’s going to cut their life short. I can’t believe anybody from the Church would want that.”

In the United States, on February 25-26, 2014, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee conducted two days of hearings on the topic of mitochondrial donation (specifically, oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility). The advisory committee panel discussed what controls might be used in trials, how a developing embryo might be monitored during those tests, and who should oversee the trials. No decisions were made at the end of the session.

 

If You Operate 20 or More Food Vending Machines, Here is What You Need to Know

The FDA believes that by requiring vending machine operators to provide accurate and clear calorie information for food sold from their vending machines, consumers will be able to make more informed and healthy dietary choices. To that end, on December 1, 2014, the FDA implemented the vending machine food labeling provisions contained in section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA) (P.L. 111-148) by establishing requirements for providing calorie declarations for food sold from certain vending machines. Section 4205 of the ACA added section 403(q)(5)(H)(viii) to the Federal Food Drug & Cosmetic Act (21 U.S.C. sec. 343(q)(5)(H)(viii)).

The new regulations (21 C.F.R. 101.8), not effective until December 1, 2016, apply only to “vending machine operators” who own or operate 20 or more “vending machines” or who register with the FDA and voluntarily agree to be subject to the new requirements.

To determine if the requirements are applicable to a person or entity, they must first determine if their machines are “vending machines” and whether they are a “vending machine operator” under the FDA’s definition. If they determine that they are a vending machine operator with 20 or more vending machines under the FDA definitions, then they must abide by the rules governing the location and format of the calorie declaration, the disclosure of contact information, and the maintenance and availability of certain records. The failure to comply with the calorie declaration requirements will render the food in the vending machines adulterated under section 403 of the FD&C Act (21 U.S.C. 343).

Definitions

Under the new regulations,  a vending machine is defined by the FDA to mean “a self-service machine that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses servings of food in bulk or in packages, or prepared by the machine, without the necessity of replenishing the machine between each vending operation.”

According to the FDA, this definition of vending machine could encompass, but is not limited to, vending machines that sell soft drinks, packaged snacks, hot-and-cold cup beverages, refrigerated prepared food (such as those sold from turnstile vending machines), and handfuls of nuts or candies (such as those sold from bulk vending machines). Game machines are excluded from the definition, even if they sometimes dispense candy or other edible items as part of the game.

A vending machine operator is defined as “a person or entity that controls or directs the function of the vending machine, including deciding which articles of food are sold from the machine or the placement of the articles of food within the vending machine, and is compensated for the control or direction of the function of the vending machine.”

Location of Calorie Declaration

If the food sold from the vending machine permits the consumer to examine the Nutrition Facts label before purchase, or otherwise provides visible nutrition information at the point of purchase (such as through front-of-pack calorie labeling), then no further calorie declaration is required. For all other articles of food that do not meet this criteria, the vending machine operator must provide calorie declarations on a sign (which can be a sticker) close to the article of food or selection button (i.e., in, on, or adjacent to the vending machine). The sign does not need to be attached to the vending machine as long as the calorie declaration is visible at the same time as the food, its name, price, selection button, or selection number is visible. Electronic or digital display of the calorie information is also permitted.

Calorie Declaration Format

Generally speaking, the calorie declarations must be clear, conspicuous and prominently placed. When the calorie declaration is in or on the vending machine, it must be:

  • in a type size no smaller than the name of the food on the machine, the selection number, or the price of the food as displayed on the vending machine, whichever is smallest;
  • displayed with the same prominence, meaning the same color, or a color at least as conspicuous, as the color of the name or price of the food or selection number; and
  • set against the same contrasting background, or a background at least as contrasting as the background used for the item it is in close proximity to, i.e., name, selection number, or price of the food item as displayed on the machine.

When the calorie declaration is on a sign adjacent to the vending machine, the calorie declaration must be (1) in a type size large enough to render it likely to be read and understood by the consumer under customary conditions of purchase and use, and (2) in a type that is all black or one color on a white or other neutral background that contrasts with the type color.

Vending machine operators may rely on a number of ways to determine the calorie content for foods sold in their vending machines, including the food package’s Nutrition Facts Label, the manufacturer or supplier of the food, nutrient databases, cookbooks, or laboratory analyses.

Recordkeeping

The FDA expects vending machine operators to generate and maintain a record of the information regarding how they determined the calorie content for their vending machine foods. Operators should be prepared to share the record of information with the FDA during an inspection if the agency needs to determine whether the posted calorie declarations are truthful and not misleading.

Enforcement

The FDA is requiring vending machine operators to disclose their contact information on their vending machines. This information must include the operator’s name, telephone number, and mail or email address. The agency plans to use this information to contact operators for enforcement purposes. The failure to comply with the calorie declarations requirements will render vending machine food misbranded under the federal Food, Drug & Cosmetic Act.

FDA Guidance

In August 2010, the FDA issued guidance titled “Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws.” The guidance was last updated on July 9, 2014. Additional information can be obtained from the FDA’s Menu and Vending Machines Labeling Requirements webpage, which was updated on December 2, 2014.

Miami Home Health Owner Gets 106 Months, Ordered to Pay $21M in Restitution

The U.S. Department of Justice (DOJ) announced that Ramon Regueira, the owner and operator of a Miami home health care agency (HHA), was sentenced to 106 months in prison for his participation in a $30 million Medicare fraud conspiracy. In addition to the prison sentence, Regueira, 66, of Miami, was ordered to pay $21 million in restitution, both jointly and severally with co-conspirators.

Plea Agreement

According to the DOJ, Regueira was an owner of Nation’s Best Care Home Health Corp. (Nation’s Best), a Miami HHA that purported to provide home health and therapy services to Medicare beneficiaries. Regueira admitted that from January 2007 through January 2011, he and his co-conspirators:

  • operated Nation’s Best for the purpose of billing the Medicare program for, among other things, expensive physical therapy and home health services that were not medically necessary or not provided;
  • paid kickbacks and bribes to patient recruiters who provided patients to Nation’s Best, as well as prescriptions, plans of care (POCs) and certifications for medically unnecessary therapy and home health services; and
  • used these prescriptions, POCs and medical certifications to fraudulently bill the Medicare program for unnecessary home health services.

Co-Conspirator

On September 26, 2013, the DOJ announced that co-conspirator Emilio Amador, 46, pleaded guilty to his involvement with fraudulent billings for Nation’s Best. Amador, who was an owner, operator, and the president of Nation’s Best, also received 106 months in prison and was ordered to pay restitution.

According to the DOJ, Nation’s Best submitted approximately $30 million in claims for HH services that were not medically necessary or not provided, and Medicare paid approximately $21 million for these fraudulent claims.

Omnicare Accused of Anti-Kickback Violations for Promoting Abbott’s Depakote®

A federal False Claims Act (FCA) lawsuit has been filed by the U.S. Department of Justice (DOJ) against Omnicare Inc., the nation’s largest provider of pharmaceuticals and pharmacy consulting services to nursing homes. The DOJ’s complaint alleges that Omnicare solicited and accepted millions of dollars in kickbacks from Abbott Laboratories to promote Abbott’s anti-epileptic drug, Depakote®, for controlling behavioral disturbances exhibited by dementia patients residing in nursing homes serviced by Omnicare.

Prior Settlement by Abbott

In May 2012, the United States, numerous individual states, and Abbott entered into a $1.5 billion global civil and criminal resolution that, among other things, resolved Abbott’s civil liability under the FCA for its unlawful promotion of Depakote for uses not approved as safe and effective by the FDA. The resolution, the second largest payment by a drug company, included a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also was made subject to court-supervised probation and reporting obligations for Abbott’s Chief Executive Officer and Board of Directors.

The DOJ’s Complaint

Federal regulations designed to protect nursing home residents from unnecessary drugs require nursing homes to retain consulting pharmacists. According to the DOJ’s complaint, Omnicare’s consulting pharmacists reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients. The complaint alleges that Omnicare used its influence over physicians in the nursing homes they serviced to secure kickbacks from pharmaceutical companies such as Abbott. The complaint further alleges that Omnicare:

  • disguised the kickbacks it received by accepting payments from Abbott described as “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend Depakote;
  • solicited contributions from Abbott and other pharmaceutical manufacturers to its Re*View program, which was not a “health management” or “educational” program as claimed by Omnicare, but simply a means by which Omnicare solicited kickbacks; and
  • entered into agreements with Abbott by which Omnicare was entitled to increasing levels of rebates based on the number of nursing home residents serviced and the amount of Depakote prescribed per resident.

Finally, the complaint alleges that Abbott funded Omnicare management meetings on Amelia Island, Florida, offered tickets to sporting events to Omnicare management, and made other payments to local Omnicare pharmacies.

Previous Omnicare Settlement

In June, 2014, Omnicare agreed to pay $124.24 million for allegedly offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to supply drugs to elderly Medicare and Medicaid beneficiaries. The settlement resolved allegations that Omnicare submitted false claims by entering into below-cost contracts to supply prescription medication and other pharmaceutical drugs to skilled nursing facilities and their resident patients to induce the facilities to select Omnicare as their pharmacy provider.

Whistleblower Suits

The DOJ filed its current complaint against Omnicare in two consolidated whistleblower lawsuits filed under the FCA in the Western District of Virginia. The cases are U.S. ex rel. Spetter v. Abbott Labs, Case No. 10-cv-00006 and U.S. ex rel. McCoyd v. Abbott Labs, Case No. 07-cv-00081.

The government’s complaint contains allegations only. There has been no determination of liability against Omnicare.