Latelines for Jan. 7, 2002
Missouri legislator Susan Phillips introduced a bill to make it a state crime to dilute a prescription drug without the consent or knowledge of the prescriber and to dispense it knowing that it may impair the effectiveness of the drug. The bill would also make it a crime to represent a diluted drug as full strength in order to mislead the patient or person administering the Rx. The bill follows the highly publicized case of Robert Courtney, a Kansas City R.Ph. facing 20 criminal counts for allegedly diluting chemotherapy drugs.
The FDA has finally approved Schering-Plough's Clarinex (desloratadine) 5-mg Tablets for the treatment of seasonal allergic rhinitis. The agency had delayed its approval due to quality control concerns at the manufacturer's plants. The H1 receptor antagonist is to be taken once a day and can be used by those who are 12 years of age or older. Schering-Plough has pinned its hopes on Clarinex as the successor to Claritin, whose patent is expected to expire this year.
Novartis Pharmaceutical Corp. selected McKesson Health Solutions to administer its CareCard drug discount program. The free card became available Jan. 2 for Medicare recipients without Rx coverage who meet income guidelines. Discounts of 25% or more are available on selected Novartis products. McKesson will process applications, issue the cards, and work with participating pharmacies to process the Rx claims.
Certain lots of VAQTA (Hepatitis A Vaccine, Inactivated) in prefilled syringes are being voluntarily recalled by Merck on grounds that they contain less antigen than specified. The lots apply to certain adults who were vaccinated after May 29, 2001, and some children who received the pediatric formulation after Aug. 9, 2001. Another recall involves 1-oz. bottles of Weider's Eyedrops and Welder's Eyedrops from Aloe Flex Enterprises. The OTCs were found to contain bacteria. More information on both recalls can be found on FDA's MedWatch site.
The Prescription Access Litigation consumer group filed a lawsuit charging 28 drug companies with manipulating the average wholesale price of drugs covered by Medicare. Filed in the Massachusetts U.S. District Court, the suit alleges that the defendants pocketed more than $800 million in illegal profits from Medicare and Medicaid patients by giving physicians large AWP discounts. Noting that federal law prohibits a trade association's involvement in the pricing strategies of its members, a PhRMA spokesman declined to comment on the lawsuit.
The new hospital outpatient prospective payment rates set to go into effect on New Year's Day were postponed by the Centers for Medicare & Medicaid Services. After issuing the final regulation in late November, CMS found miscalculations in the assignment of the cost of some new technology devices to related procedure codes. When corrections are made, CMS will review all outpatient codes. Hospitals will be paid at the 2001 rate until the review is completed no later than March 31.
A 10-member management team has purchased Hamacher back from NONSTOP Solutions. NONSTOP, a San Francisco-based soft-ware company, purchased Hamacher in August 2000. The new company is called Hamacher Resource Group. Dave Wendland, v.p. of Hamacher Resource Group, told Drug Topics, "It was an amicable departure. It was a mutual decision to spin off the Hamacher business. It allows us to concentrate on our core competencies." Dawn Vogelsang was named president of Hamacher Resource Group.
Zithromax (azithromycin for oral suspension), which was approved in 1995 as a once-daily, five-day treatment of acute otitis media in children, will be available as a single-dose as well as three-day regimen for kids. Pfizer said the drug's special characteristics produce high and sustained drug levels, enabling a short course of treatment. An educational campaign to inform health professionals and patients about the new regimens will support the launch.
SureScript Systems has appointed David Weinstein to head the venture formed to provide direct electronic links between prescribers and pharmacists. A cofounder and former CEO of the electronic prescribing pioneer eScript Inc., Weinstein is president and CEO of SureScript, which was formed by NACDS and NCPA to compete with RxHub, the e-connectivity firm set up by three large PBMs.
Actinic keratosis patients have a new treatment optionBioglan Pharma's Solaraze (diclofenac sodium) Gel. The gel should be applied twice a day for two to three months. The Malvern, Pa., firm claims its product is the first topical NSAID to get the FDA's blessing for this condition. Before this drug was approved, patients were treated with 5-fluorouracil (5-FU), aminolevulinic acid HCl, or cryosurgery.
Novartis' Elidel (pimecrolimus) Cream 1% is a new second-line therapy for mild to moderate eczema sufferers as young as two years old. A nonsteroidal product, Elidel was tested in more than 1,700 adult and pediatric patients; it relieved itching and redness within eight days of treatment. Packaged in tubes of 15 gm, 30 gm, and 100 gm, the topical product should be used on a short-term or intermittent long-term basis.
The first combination statin-based drug for lowering cholesterol has been approved. It's Kos Pharmaceuticals' Advicor (extended-release niacin/lovastatin). The drug is indicated in patients with primary hypercholesterolemia and mixed dyslipidemia who were formerly treated with either niacin or lovastatin and who require additional adjustment of their cholesterol levels. Advicor will come in 500 mg, 750 mg, and 1,000 mg of niacin, along with 20 mg of lovastatin. The combo drug will be promoted only by Kos and not in conjunction with Bristol-Myers Squibb as originally planned.
GlaxoSmithKline's Paxil (paroxetine HCl) has gained a new indication. The selective serotonin reuptake inhibitor, formerly approved for treating depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and generalized anxiety disorder, is now cleared to treat posttraumatic stress disorder. The company claims that, with this indication, Paxil is the first and only drug indicated to treat depression and all of the major anxiety disorders.
As a result of manufacturing difficulties affecting Merck's sterile product lines, the company temporarily halted production of its antifungal Cancidas (caspofungin acetate). Although production has now resumed, the company has launched a patient allocation program to address any shortage. In addition, Merck has informed the FDA that it is limiting the product. The company plans to manage the shortage through an allocation program, which will limit patients to a one-week supply of Cancidas. Merck indicated that, at the request of a physician or hospital pharmacist, it would provide additional supply for patients needing therapy beyond seven days.
Latelines for Jan. 7, 2002. Drug Topics 2002;1:6.