CVS Caremark announces settlement of PSE sales suit
WOONSOCKET, R.I. Under a settlement reached with the Drug Enforcement Administration and the U.S. Attorneys’ Offices for the Central District of California and the District of Nevada, CVS Caremark has agreed to pay $75 million in civil penalties and $2.6 million in profit forfeitures to settle allegations that in 2007 and 2008, certain CVS/pharmacy stores in California and Nevada engaged in unlawful sales of pseudoephedrine.
CVS also must maintain certain compliance measures to monitor and prevent excessive sales of the ingredient found in popular over-the-counter cold-cough medicines. In addition, the settlement acknowledged that a distribution center in California failed to monitor and report excessive PSE sales by CVS/pharmacy stores; it related only to the retail pharmacy business.
“We are announcing today that we have resolved this issue, which unfortunately resulted from a breakdown in CVS/pharmacy’s normally high management and oversight standards,” stated Tom Ryan, chairman and CEO of CVS Caremark. “While this lapse occurred in 2007 and 2008, and has been addressed, it was an unacceptable breach of the company’s policies and was totally inconsistent with our values. CVS/pharmacy is unwavering in its support of the measures taken by the federal government and the states to prevent drug abuse. To make certain this kind of lapse never takes place again,” Ryan continued, “we have strengthened our internal controls and compliance measures, and made substantial investments to improve our handling and monitoring of PSE by implementing enhanced technology and making other improvements in our stores and distribution centers.”
The settlement does not impact any other business conducted by CVS or any of its affiliated companies. In addition, the settlement amount has been fully reserved, as previously disclosed, and should have no further effect on the company’s financial results, the company stated.
The settlement related to excessive sales of PSE at certain CVS/pharmacy locations that resulted from the flawed implementation of an electronic monitoring system to record individual PSE sales. As implemented in California, Nevada and certain other states, the system did not prevent multiple sales of PSE that totaled more than the federal daily legal limit, which made certain CVS/pharmacy stores vulnerable to criminals who intended to purchase large amounts of PSE. The excessive sales occurred primarily in California and Nevada. The settlement includes not only federal jurisdictions in California and Nevada, but also federal jurisdictions in 23 other states where the system was not implemented properly, CVS stated.
CVS/pharmacy reaches mobile customers with iPhone app
WOONSOCKET, R.I. CVS/pharmacy has developed a free, downloadable application for mobile customers that seek to manage their prescriptions and shopping lists on the go.
The drug store chain said that its app is available for the iPhone, can be downloaded from iTunes or the Apple app store and allows customers to take advantage of the following features:
- Find nearby CVS/pharmacy locations using the GPS-based store locator with integrated driving directions and maps;
- Refill prescriptions from a personalized prescription history for pickup at any CVS/pharmacy;
- Transfer prescriptions from another pharmacy to CVS/pharmacy;
- Access the Drug Information Center to retrieve critical details about medication management, including instructions for use, dosing information, side effects and relevant safety warnings;
- View and manage sales circular to create a custom shopping list and identify money-saving deals each week; and
- Schedule a flu shot at any local CVS/pharmacy location.
“We have introduced the CVS/pharmacy mobile application to give customers the ability to manage prescriptions and access important health information from any location,” said Rob Price, SVP marketing and chief marketing officer for CVS/pharmacy. “In addition to managing prescriptions, the mobile application will provide instant access to our flu shot scheduler, and even allow customers to plan shopping trips in advance using our mobile circular. With more than 7,000 locations and the addition of this mobile application, CVS/pharmacy continues to be the most convenient destination for our customers’ healthcare needs.”
FDA targets dietary supplements maker for selling unapproved, misbranded drugs
SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.
Prior to entry of the consent decree, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases, such as breast cancer, asthma, anemia and epilepsy. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.
“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” stated Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures.”
Under the consent decree, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.
The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.