NABP e-News: January 8, 2009

January 8, 2009 12:00 AM

Pharmaceutical Industry Agrees to Moratorium on Drug Maker Gifts
Pharmaceutical companies have agreed to stop giving branded gifts, such as pens, mugs, and mouse pads, to practitioners starting January 1, 2009. Critics of this practice say it encourages doctors to prescribe more of the drugs, the New York Times reported on December 30, 2008. The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors unanimously adopted measures in June 2008 to enhance the PhRMA Code on Interactions with Healthcare Professionals to include this provision. “The revised, voluntary code reaffirms that interactions between pharmaceutical company representatives and healt h care professionals should be focused on informing the health care professionals about products, providing scientific and educational information, and supporting medical research and education,” according to a PhRMA statement naming 38 companies that signed on to the agreement as of December 19, 2008.

RFID Compliance Policy Guide Expiration Date Extended through 2010
Food and Drug Administration (FDA) is extending the expiration date of compliance policy guide (CPG) section 400.210, “Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs,” to December 31, 2010. The CPG, introduced in 2004, describes how FDA intends to exercise its enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to studies involving RFID technology for drugs. The goal of the CPG is to facilitate performance of RFID studies and to allow industry to gain experience with the use of RFID technology and its effect on the long-term safety and integrity of the United States drug supply.

The Food and Drug Administration Amendments Act of 2007 includes a provision requiring the development of standards for the identification, validation, authentication, and tracking and tracing of prescription drugs. These new standards are to address promising technologies, which may include RFID technology. FDA is currently addressing such issues that may be relevant for the CPG. More information is available in the Federal Register [Docket No. FDA-2004-D-0298].

FDA Warns Consumers about Tainted Weight Loss Pills
FDA is alerting consumers nationwide not to purchase or consume any of more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may pose a risk to patients’ health. An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually c ontain potentially harmful ingredients not listed on the product labels or in promotional advertisements. More information, including a list of the products in question, is available on the FDA Web site.

HHS Releases Guidance for Use, Stockpiling of Pandemic Flu Drugs
Health care workers and emergency services personnel who could have direct contact with individuals who are ill during an influenza pandemic should be protected with antiviral drugs throughout the pandemic, even before these workers are exposed or become ill themselves, according to guidance released December 16, 2008, by the US Department of Health and Human Services (HHS). Stockpiling these antiviral drugs and planning for their use is the responsibility of employers as part of comprehensive pandemic preparedness, the guidance says.

The guidance also recommends preventive antiviral drug use for certain individuals following exposure to someone who is sick with pandemic influenza. HHS continues to recommend using antiviral drugs to treat people with pandemic influenza illness as a way to s low the spread of pandemic disease. National and state antiviral drug stockpiles, intended primarily for these uses, contain enough antiviral drugs for more than 72 million people.