Latelines for Feb. 4, 2002
Are you satisfied with the FDA's drug approval record in 2001, when 24 new molecular entities and eight biologics received clearance? Drug Topics ran an instant poll on this question on its Web site last month. Half of respondents said they were not satisfied, about one-third said they were satisfied, and 16% said they didn't care. The poll obtained 242 responses.
Patients with advanced prostate cancer have a new drug they can use. It's Eligard (leuprolide acetate) 7.5 mg from Atrix and Sanofi-Synthelabo. Called Leuprogel One-Month Depot while it was under investigation, Eligard is similar to Lupron Depot (TAP), which is already on the market. But while Lupron Depot involves an intramuscular injection using microsphere technology, Eligard is a subcutaneous injection using the Atrigel drug delivery system, which forms a solid implant in the body for extended release of the agent. Eligard 7.5 mg provides drug coverage for one month. Atrix has filed an application for a three-month formulation of the drug with the FDA.
The Emerson-Ross bill has been introduced in the House of Representatives. The bill, which guarantees that senior citizens receive coverage for prescription drugs and the pharmacy services needed to ensure their proper use, also provides seniors with complete freedom to select the drugs and pharmacy providers that best meet their needs. Seniors would pay a 20% co-pay for their medications. APhA praised the bill as "an important step toward ensuring patient safety by including the provision of medication therapy management services." The Pharmacy Benefits All Coalition also applauded the bill, saying that it "represents a high-water mark" for prescription drug legislation in Congress because it focuses on providing seniors with comprehensive Rx coverage as well as pharmacy services needed to ensure the drugs they receive work most effectively.
Pharmacies that received a box of Clarinex (desloratadine) that included a sample packet of the new antihistamine should set the sample aside and await further instructions from Schering-Plough Corp., according to a spokesman for the Kenilworth, N.J., drug firm. The samples, which are illegal in pharmacies, were inadvertently included in some of the complimentary shipments of Clarinex.
Come March, American Home Products (AHP) will become Wyeth to reflect the firm's emphasis on pharmaceuticals and vaccines. Wyeth-Ayerst Pharmaceuticals will drop the Ayerst name, and Whitehall-Robins Healthcare will become Wyeth Consumer Healthcare. Founded in 1926, AHP has shed a number of household products in recent years, including Chef Boyardee, Jiffy Pop, and Easy-Off oven cleaner, to concentrate on the Rx drug business.
A California assembly committee killed a provision in a board of pharmacy bill to establish pharmacist license reciprocity with the rest of the country. The committee also nixed a provision that would have made the NAPLEX California's licensure examination. However, a section was added to the bill to require that the state's current licensure exam be administered 12 times per year, instead of twice. The original bill was opposed by the California Pharmacists Association, a labor union, and consumer groups. Supporters included the California Society of Health-System Pharmacists and NACDS.
Five men have been indicted for scheming to steal 600 units of the growth hormone Saizen (somatropin, Serono) from a Phoenix area pharmacy, and three men have been indicted for the kidnapping and murder of a coconspirator who turned police informant. Two days after the gang failed to hijack the delivery truck, a son-in-law of the pharmacy owners quietly sold the drug to a wholesaler for nearly $1 million, according to the police. A week later, the conspirators staged a fake robbery at the pharmacy, presumably to collect insurance, which the owners' son had increased on the day of the robbery. Investigators are puzzled by this plot because growth hormone is not a likely target for theft, although it is used illegally by athletes.
Schering-Plough has set up a waiting list for patients who haven't registered to get its hepatitis C treatment, Peg-Intron. The company said demand is exceeding supplies. More than 60,000 patients have enrolled in Schering-Plough's mandatory registration program for injectable Peg-Intron. The waiting list is being set up because the company won't be able to ensure new patients a complete course of the drug, which is typically 48 weeks.
The National Council on Patient Information & Education (NCPIE) is joining the FDA to kick off Be MedWise, a public education campaign about the safe use of OTCs. The campaign coincides with the changeover in 2002 to a standardized "Drug Facts" label, which will appear on most OTCs. The effort will use the new label as a way to raise awareness that OTCs are serious medicines that must be taken with care. The campaign includes TV and radio ads and a Web site at www.bemedwise.org .
Michigan officials plan to implement a controversial program to curb Rx costs after the state court of appeals stuck down an earlier injunction. The court did, however, agree to hear the case filed by PhRMA last November. At the heart of the legal battle is the state's formulary of best-in-class drugs in 40 categories. The makers of drugs that didn't make the list were required to give rebates to get on the formulary. Several firms refused. Physicians will have to get prior authorization from the state before prescribing nonformulary drugs. Seen as a bellwether by other states, Michigan's program hopes to save $42 million annually from the plan covering 1.6 million residents.
Betaseron (interferon beta-1b) for multiple sclerosis is now available in a new room-temperature formulation for subcutaneous injection. Manufactured by Chiron and sold by Berlex Laboratories, this version of Betaseron is the first and only MS therapy that does not require refrigeration, according to the two companies. The new formulation, which will be available midyear, is expected to provide more convenience to the 350,000 MS patients in this country.
The Bayer Group is now listed on the New York Stock Exchange. The German firm's new operating model is a management holding company with four independent subsidiaries focusing on health care, crop sciences, polymers, and chemicals. If shareholders approve the reorganization in April, officials say the new corporate structure will be in place by Jan. 1, 2003.
Nevada's attorney general sued nine drug companies alleging that they fraudulently manipulated average wholesale prices to reap millions in illegal profits. The suit seeks restitution to the state and to Nevada consumers for an amount yet to be calculated. The defendants include Abbott Laboratories, Baxter Pharmaceutical Products, Bayer, Bristol-Myers Squibb, TAP Holdings, Warrick Pharmaceuticals, Pharmacia, and GlaxoSmithKline.
Enbrel (etanercept, Immunex Corp. and Wyeth-Ayerst Laboratories), which is already approved as a treatment for rheumatoid arthritis, has been cleared by the FDA to manage psoriatic arthritis. The companies claim their tumor necrosis factor inhibitor is the first therapy to receive this indication approval. The National Psoriasis Foundation estimates that there are about one million people who have psoriatic arthritis in this country. The disease involves inflammation of the skin and joints. Etanercept can be used with or without methotrexate and should be avoided in patients with infections.
Marina Marketos. Latelines. Drug Topics 2002;3:7.