Emerging laws of different types and different origins could affect the supply of OTC drugs and nutritional products, "The Tan Sheet" finds this week. While in the U.S. more states are considering Rx-only laws for all pseudoephedrine-containing drugs and in Europe the EU drug regulator recommends pulling an Rx weight-loss ingredient off the market, the law of nature could affect the supply of omega-3 fatty acids.
River of Rx-only PSE bills reaches Mississippi: Local media report…
Alli could benefit from EU pulling Rx weight-loss ingredient: European media state…
Fatty acid sales may trim the fish population: Time magazine says…
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River of Rx-only PSE bills reaches Mississippi: Putting nonprescription drugs containing pseudoephedrine behind store counters and requiring logs of retail sales are not enough to prevent consumers from purchasing the products as methamphetamine precursors, according to bills filed in the Mississippi state legislature.
Mississippi state Sen. Sidney Albritton, a Republican from the Picayune area, and Rep. Ed Blackmon, a Canton-area Democrat, both introduced legislation -- Senate Bill 2339 and House Bill 512 -- to make PSE a prescription-only drug, Clarionledger.com reports here. Law enforcement officials asked lawmakers to file the bills following a record number of meth arrests in the state in 2009, Gulflive.com reports here.
In Missouri, Rep. Scott Lipke, a Jackson-area Republican, filed similar legislation, the Southeast Missourian reports here.
Proposals to move all PSE products to Rx only failed in 2009 in Missouri as well as in California, Georgia, Indiana and Washington, "The Tan Sheet" reported here.
Mississippi began requiring behind-the-counter sales of nonprescription PSE products in 2005, a year before the federal Combat Methamphetamine Act was passed, requiring BTC sales and logs of retail transactions in all states while allowing states to impose more stringent limits.
Oregon is the only state to enact an Rx-only law for all PSE products. However, Consumer Healthcare Products Association members are funding electronic systems to track nonprescription sales of PSE products to dissuade states from moving those drugs to prescription status.
The National Precursor Log Exchange system will track all purchases of nonprescription ephedrine- or pseudoephedrine-containing products in states that require e-tracking. The information will be available to law enforcement agencies and retailers within a state and to other states linked into the network. Law enforcement agencies and retailers will not have to pay to implement or access NPLEx.
Alli could gain from EU pulling Rx weight-loss ingredient: A European Union agency's recommendation to pull prescription weight-loss ingredient sibutramine off the market could provide a boost for alli, GlaxoSmithKline's nonprescription weight-loss drug that recently drew unwanted attention after counterfeit products adulterated with sibutramine were linked to adverse events.
The Independent in London reported here that the European Medicines Agency completed a safety review of Rx drugs containing sibutramine -- including the brands Meridia, Reductil, Reduxade and Zelium -- and concluded the medicines' risks are greater than their benefits and recommended the suspension of marketing authorizations across the EU.
EMA's Committee for Medicinal Products for Human Use instructed physicians to stop prescribing and pharmacists to cease dispensing the drugs, and advised consumers using the products to consult their doctors about alternative treatments. The committee said consumers should stop using the drugs if they choose to before consulting a doctor, according to EMA's release here.
Doctors in EU member states can prescribe other Rx weight-loss drugs for patients including products containing orlistat as the active ingredient. However, consumers in those countries also could choose alli, nonprescription 60-mg orlistat.
GSK, which launched alli in Europe in 2008 after the EU's first centralized process for an Rx-to-OTC switch, warned consumers Jan. 18 that "a small quantity" of "falsely packaged and labeled" alli was sold online at sites such as eBay, "The Tan Sheet" reported here.
The 120-count fake alli refill packages contain sibutramine instead of orlistat. GSK says consumers can confidently buy alli from retail stores and their branded online Web sites. Glaxo's quick response to consumer complaints about counterfeit alli for sale online exemplifies effective crisis management and could even boost the OTC weight-loss brand's reputation, an expert told us.
Fatty acid sales may trim the fish population: U.S. sales of omega-3 supplements have doubled to an estimated $1 billion since 2006, without including the billions consumers spend for infant formula, orange juice, breakfast cereals and other products made with the fatty acids.
However, Time magazine reports here that demand for omega-3s and other fish oil-containing products may lead to ecological losses -- environmentalists are concerned about over-fishing of species that are omega-3 sources, including salmon and mackerel as well as the lesser-known menhaden, which help clean the Atlantic Ocean and the Gulf of Mexico by eating omega-3-laden algae.
A Columbia, Md.-based firm that has built its business on providing omega-3-based ingredients for infant formula, Martek Biosciences, looks to expand into consumer marketing while also broadening its portfolio with its proposed $200 million acquisition of health and wellness firm Amerifit Brands, we reported here.
Martek's overall revenue dipped 2 percent in fiscal 2009 after increasing 15 percent from fiscal 2007 to fiscal 2008, and analysts say investors have become increasingly antsy about the firm's heavy concentration on infant formula ingredients.
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-- Malcolm Spicer (m.spicer@elsevier.com)
