PHARMACY

McKesson to pay $13 million-plus for failure to report suspicious sales

BY Drew Buono

WASHINGTON McKesson has agreed to settle allegations that it violated federal reporting provisions relating to its handling of controlled prescription medications regulated by the Drug Enforcement Administration. Under the agreement between the company and six U.S. Attorney’s Offices, McKesson has agreed to pay $13,250,000 in civil penalties for alleged violations of its obligations under the Controlled Substances Act.

McKesson, which operates 30 DEA-registered distribution facilities, failed to report to the agency suspicious sales of controlled substance pharmaceuticals it made to pharmacies that filled orders from illegal “Internet pharmacies” that sell drugs online to customers who do not have a legal prescription. McKesson also failed to report suspicious orders of controlled substances that it received from other pharmacies and clinics even though the orders were unusually large. Every DEA registrant is required to report to the DEA any suspicious orders or the theft or significant loss of controlled substances.

Three McKesson distribution centers received and filled hundreds of suspicious orders placed by pharmacies participating in illicit Internet schemes, but failed to report the orders to DEA. They did so even after a Sept. 1, 2005, meeting at which DEA officials met with and warned McKesson officials about excessive sales of their products to pharmacies filling illegal online prescriptions.

The United States Attorneys allege that the orders that McKesson received from these pharmacies were unusually large, unusually frequent, and/or deviated substantially from the normal pattern. As a result, millions of dosage units of controlled substances were diverted from legitimate channels of distribution.

“By failing to report suspicious orders for controlled substances that it received from rogue Internet pharmacies, the McKesson Corp. fueled the explosive prescription drug abuse problem we have in this country,” said DEA acting administrator Michele Leonhart. “This civil penalty demonstrates the strong action DEA is taking to cut off the drug supply to pharmacies engaged in Internet diversion schemes.”

The civil penalty will be collected by the U.S. Attorney’s Office in each of the following districts, in the amounts indicated:

  • Middle District of Florida $7,456,000
  • District of Maryland $2,000,000
  • District of Colorado $1,000,000
  • Southern District of Texas $2,000,000
  • District of Utah $544,000
  • Eastern District of California $250,000

The settlement agreement is neither an admission of liability by McKesson nor a concession by the United States that its claims are not well founded.

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PHARMACY

Hormone deemed effective in male birth-control pill

BY Drew Buono

TORRANCE, Calif. According to published reports, one of the two government-funded research centers in the U.S. for male contraceptives has discovered hormone pills that block sperm production in men and has found them to be safe and reversible.

The hormone combination that proved most successful halts testosterone production in the testicles, but fakes the body into believing that testosterone levels are the same, according to the study. The progestin, typically a female hormone, speeds the process and improves the effectiveness of the drug, research shows. The hormones can be taken in a pill or injection form.

As with female birth control, the male contraceptives don’t prevent sexually transmitted disease. But they have proven as effective as female pills in preventing pregnancy, according to the study.

The next goal is to find pharmaceutical companies that want to conduct final development of the drug, but so far companies have been unwillingly to take part because of the regulatory requirement involved in manufacturing a contraceptive.

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Federal appeals court lets Washington state Plan B ruling stand

BY Drew Buono

LOS ANGELES A federal appeals court on Thursday left in place a lower court’s ruling that allowed Washington state pharmacists to refuse to sell Duramed’s emergency contraceptive pill Plan B on religious grounds, according to Reuters.

A federal judge in Seattle suspended state rules that required pharmacies to dispense the drug and other emergency contraceptives that prevent fertilized eggs from implanting, which some people believe is the same as abortion.

U.S. District Judge Ronald Leighton found that the state rules force pharmacists into an unconstitutional choice between their religious beliefs and their work.

State officials and several women had asked the Ninth U.S. Circuit Court of Appeals to suspend the judge’s preliminary injunction, which bars them from enforcing the law, while they appeal his ruling.

In a split decision, the appeals court denied that request, finding that the state and the women did not show that they would suffer irreparable harm if the injunction stayed in place pending the appeal.

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