In Brief

GSK victim of OTC cargo theft

GlaxoSmithKline reports the theft of eight lots of Tums and one lot of Os-Cal – more than 3,000 cases total. The firm said Jan. 14 it is collaborating with FDA's Office of Criminal Investigations and the Federal Bureau of Investigation to recover the calcium supplements, which were intercepted Jan. 9 after leaving a GSK facility in St. Louis. According to FreightWatch International, overall cargo theft rose 4.1% to 899 incidents in 2010. Though pharmaceuticals comprised only 5% of those thefts, they represented the majority of financial loss – about $3.8 million per incident. Consumer care products represented 6% of 2010 cargo thefts, FreightWatch says. FDA advised industry in 2010 to review their in-transit and warehouse security practices ("FDA cargo theft warning," "The Tan Sheet" May 3, 2010, In Brief).

CRN gives retailers guidance on claims

The Council for Responsible Nutrition releases a "Roadmap for Retailers" pamphlet with tips for selling supplements without violating the law. It includes sections on testimonials, third party literature, supplement labels and the laws governing regulation of supplements. "There is a fine line that retailers walk between making claims that are helpful to their customers versus claims that run afoul of the law," CRN President Steve Mister said.

L'Oreal needs more time to compile TEAs

FDA should raise its estimated amount of time for a firm to prepare time-and-extent applications for adding ingredients to an OTC monograph, according to sunscreen maker L'Oreal. FDA's 2002 TEA final rule projected 480 hours to complete a TEA and 800 to compile and submit safety and efficacy data, but L'Oreal says in a Dec. 7 letter it needs 1,526 hours and 2,348 hours respectively to complete submissions. Collecting data on sunscreen active ingredients is challenging because many countries do not regulate them as pharmaceutical actives.

U.K. eyes GSL for salicylic acid product

The U.K. considers moving from pharmacy access to general sales list, or over-the-counter, skin-care products with a higher concentration of salicylic acid than other products already available GSL. Diomed Development Ltd. asked the Medicines and Healthcare products Regulatory Agency for GSL status for Bazuka Extra Strength Gel topical treatment for warts, corns and calluses. Bazuka contains salicylic acid 26%, while current GSL products with the ingredient have up to 12.5%, according to a Jan. 10 notice. "There is no reason to suggest that the product's established safety profile will be adversely affected by making it available for self-selection," says MHRA, which will accept comments on the proposal through Feb. 7. In the U.S., salicylic acid is common in skin care products but is not a regulated pharmaceutical ingredient.

EMA calls for pediatric studies on herbals

The European Medicines Agency begins a consultation on the use of herbal medicinal products in children in an effort to stimulate studies on the pediatric effects of herbals. EMA's Committee on Herbal Medicinal Products published a reflection paper Jan. 18 highlighting the lack of and need for properly designed studies on herbal medicine in children. HMPC also calls for identification of herbals with an expected therapeutic benefit and additional funding for pediatric research. Public comments on the proposals are due April 15.

Perrigo buys generic Rx maker Paddock

The private label giant says Jan. 20 the acquisition gives it greater access to generic Rx spaces where there is little competition, including extended topicals and drugs that contain controlled substances. Perrigo also touted Paddock Laboratories' 25 abbreviated new drug applications. The firm expects half of the ANDAs to hit the market in 2011, with another 25% following each year in 2012 and 2013. The $540 million deal has been in the works since October 2009, CEO Joseph Papa said during a same-day analyst call. He emphasized consumer health care, specifically store brand private label, is "our major focus."

Contraceptive sponge back in Canada

Mayer Laboratories' OTC contraceptive Today Sponge returns to the Canadian market exclusively at Shoppers Drug Mart, the Berkeley, Calif., firm says Jan. 12. The distribution interruption "was the result of the previous owner's bankruptcy," CEO David Mayer said in a release. The product re-appeared on U.S. shelves in May 2009 following an FDA requirement that OTC vaginal contraceptive and spermicidal products containing nonoxynol-9 state in labeling that the product does not protect against HIV or sexually transmitted diseases (Also see "FDA Allows N-9 Products To Stay On Market, Six Months For Label Compliance" - Pink Sheet, 7 Jan, 2008.).