P&G gets warning letter from FDA regarding hand sanitizer
Procter & Gamble Co. may need to wash its hands clean of a new sanitizerthat health officials say is hazardous to children.
The Food and Drug Administration on Tuesday released a warning letter it had sent to P&G for “making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer product,” the agency stated.
The agency reported that the product’s claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act, citing specifically P&G promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours. Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims.
“FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,” stated Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “Over-the-counter drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”
Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugs’ labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed.
There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. In this case, the product’s claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph, the agency stated. Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes claims regarding the prevention of colds.
P&G spokesman David Bernens said on Tuesday that the company would comply with the FDA’s complaints.
Wolfgram testifies to Senate on behalf of NACDS
WASHINGTON Peter Wolfgram, president and chief executive officer of Bungalow Drug, testified today in front of the Senate Committee on Finance regarding the role of community pharmacy in the solution to methamphetamine production.
Speaking on behalf of the National Association of Chain Drug Stores, Wolfgram expressed his concerns before the committee as a representative of the 39,000 pharmacies and almost 1,000 suppliers of products and services to the chain drug industry that are included in NACDS’ membership. He addressed the problems of methamphetamine production and the steps taken by pharmacies to curb domestic production. He urged the committee to take appropriate measures to stem the flow of methamphetamine from abroad, and pledged that NACDS will continue working with Congress to help curb the illicit use and production of methamphetamine.
Bungalow Drug is a family-owned, hometown pharmacy chain based in Belgrade, Montana. The company provides pharmacy services for approximately 3,000 patients out of three locations in Montana with 24 employees including eight full- and part-time pharmacists. “Mr. Wolfgram brings a vast amount of chain drug experience to the table and we are pleased to have him testify on our behalf to address the proactive role of community pharmacy as part of the solution to drug abuse,” stated NACDS president and chief executive officer, Steve Anderson.
While the Combat Methamphetamine Epidemic Act or “Combat Meth Act” created a national standard for retailers to follow in order to limit access to methamphetamine precursors, and significantly reduced domestic methamphetamine production, the foreign supply is increasing as those addicted search out alternative sources of methamphetamine outside U.S. borders.
Even before the law was implemented, pharmacists had been taking proactive steps to reduce the theft and illegitimate use of products containing pseudoephedrine and ephedrine, including restricting sales, placing these products behind pharmacy and/or sales counters and participating in other drug-awareness activities.
“Chain drug stores will continue to advocate for policies and practices that will be truly effective in cutting off the methamphetamine supply chain and addressing other drug abuse issues in a way that does not limit the legitimate sale and use of medication that patients rely on,” said Anderson. “We applaud Finance Committee Chairman Max Baucus [D-Mont.] for his commitment to combating illegal drug manufacturing and abuse, and for listening to those, like community pharmacy personnel, who live out their commitment to this cause every day.”
Bayer introduces two wireless blood glucose meters in Europe
TARRYTOWN, N.Y. Bayer Healthcare on Monday announced in Europe the introduction of two new wireless blood glucose meters, the results of which will be able to be transmitted wirelessly to the patients’ insulin pump or the hospital’s central data processing system.
“The addition of these two wireless meters—Contour Pro and Contour Link—to our business has given us a new strategic focus,” stated Dr. Roberto Parotelli, head of the European Diabetes Care Division of Bayer HealthCare. “Their complimentary features will make a significant contribution to improving safety for people with diabetes.”
The new systems will be launched in selected markets in various European countries in the coming months, the company announced.