Latelines for 2b issue
Schering-Plough has sued the consumer divisions of Johnson & Johnson and American Home Products over their applications to market generic versions of Claritin (loratadine) for OTC sale. Claritin is expected to lose patent protection in December. Last May, an FDA panel backed Wellpoint Health Networks of California's petition to make Claritin and two other antihistamine drugs available without prescription. Schering-Plough recently restated its opposition to switching Claritin and the other drugs to OTC status without the consent of the manufacturers.
NCPA announced that it is launching a campaign designed to decrease the influence that pharmacy benefit managers now exert over independent pharmacies. Speaking to attendees of the NCPA/CDMA Expo 2002, held recently in conjunction with NHIA in Las Vegas, Bruce Roberts, NCPA executive v.p., told members the association will take several actions. Legislatively, NCPA will push for rulings that would grant pharmacies negotiation rights with third parties on the federal level and regulate PBMs on the state level. Professionally, NCPA will help members evaluate third-party contracts and learn from pharmacists who have successfully rejected inadequate agreements.
The Physicians Committee for Responsible Medicine has petitioned the FDA to add labeling on all oral estrogens, stating that estrogens are not approved for curbing growth in tall adolescent girls and that long-term use could cause major side effects. The committee took this action because, even though estrogens are not approved for slowing growth, a survey found that one-third of pediatric endocrinologists are ordering these products for this purpose.
In the first case of its kind, a Florida doctor is on trial for manslaughter stemming from the overdose deaths of four patients prescribed OxyContin. Two dozen pharmacists testified they stopped filling Rxs written by the physician being charged, James Graves. Referred to as "Graves cocktails," the scripts typically included OxyContin, Lortab, Vioxx, Xanax, and Soma. If convicted on all counts, Graves faces 15 to 30 years in prison. He contends that he ran a legitimate pain management practice and that the patients died because they were drug abusers.
A Nebraska legislator introduced a bill to prohibit pharmacists from releasing information about physicians except to the patient or surrogate, the prescriber, other physicians or R.Ph.s, or when authorized by law. The aim is to stop the release or sale of a physician's prescribing information to drug manufacturers by including prescribers under the "confidential and privileged" information umbrella with patients.
The FDA has warned consumers to stop using the dietary supplements/herbal products PC SPES and SPES capsules from BotanicLab since they contain the undeclared prescription drugs Coumadin (warfarin) and Xanax (alprazolam), respectively. PC SPES is promoted for prostate health, while SPES is touted for strengthening the immune system. BotanicLab has recalled the products.
Low-income Medicare recipients may qualify for discounted Rxs from Novartis Ophthalmics. The covered drugs include Rescula (unoprostone isopropyl ophthalmic solution, 0.15%), Zaditor (ketotifen fumarate ophthalmic solution, 0.025%), and Voltaren Ophthalmic (diclofenac sodium, 0.1%). The eye medication program is an extension of the drug company's free Novartis Care Card, which offers discounts of 25% off the wholesale price.
Novartis' Gleevec (imatinib mesylate), approved last year to treat chronic myeloid leukemia, has been cleared for a second indication. The signal transduction inhibitor can now be used for patients with gastrointestinal stromal tumors (GISTs), which affect about 2,000 to 5,000 patients in this country. Until the approval of Gleevec for this indication, GISTs, which are the most common malignant form of sarcoma in the GI tract, could be treated only by surgery and had a median survival rate of only up to one year.
A N.J. pediatrics group filed a class action lawsuit charging that a distributor boosted the agreed-on price of flu vaccine by 80% last fall. The suit alleges that the Caligor division of Henry Schein Inc. agreed as early as November 2000 to sell the vaccine for $35.99 per vial for orders of at least 25 vials but informed customers last August that the price was $65 per vial. At press time, the firm could not be reached for comment.
The HHS budget includes $10 million in new funding for patient safety initiatives. The additional funding would bring the total amount earmarked for patient safety to $84 million in fiscal year 2003, which begins in October. Spending will support efforts to put underused safety technologies into wider practice and to establish a stronger system for rapid reporting of adverse medical events.
Eckerd Corp. was accused of "rounding up" prescriptions that led to overcharging customers to the tune of $100 million. The class action lawsuit on behalf of several customers was filed in state district court in Ft. Lauderdale, Fla. It said the chain's inventory included 1,800 drugs that could have been used for rounding up to higher whole numbers over the amount of medicine that was actually called for in the Rxs. "We are confident that our pharmacy billing systems and procedures accurately bill our customers and comply with all governmental and industry standards," Eckerd countered in a formal statement.
Intravenous immune globulin (IVIG) will now be available to Medicare patients with certain autoimmune mucocutaneous blistering diseases, according to the Centers for Medicare & Medicaid Services. Patients who have failed conventional therapy, those in whom conventional therapy is contraindicated, and patients with rapidly progressive disease will be covered for short-term therapy with IVIG.
A New Jersey legislator has introduced a bill to require R.Ph.s to report all medication-related deaths and serious injuries to the state pharmacy board. Reports would have to be filed within 14 days of discovery of the fatality or injury. The legislator said the bill would reduce Rx errors by rooting out incompetent R.Ph.s and uncovering problems such as soundalike names and poor packaging. Currently, North Carolina is the only state that mandates reporting of Rx drug-related deaths.
Americans can now dial a single toll-free telephone number from anywhere in the Untied States to reach a poison control center. Callers dialing the national hotline, 1-(800) 222-1222, will be automatically linked to the closest poison center. The country's 65 centers had more than 130 individual and separate telephone numbers.
FEDCO Drugs, Miami Beach, Fla., has sold its stores. Peggie Charlton, FEDCO office manager, told Drug Topics, "We sold all of the stores to different people. FEDCO no longer owns them. There were about 20 stores sold. Some are up and running under different names."
ASHP has responded to the FDA's Nov. 19, 2001, Federal Register notice soliciting stakeholder comments to assist the FDA in evaluating current Prescription Drug User Fee Act (PDUFA) provisions. In its comments, ASHP recommended a broader use of the program funding for the FDA provided by PDUFA. ASHP noted that PDUFA funds have augmented the FDA's ability to approve new drugs at a faster rate and suggested that Congress consider the effect that faster drug approvals have on the safe use of medicines. ASHP also recommended that PDUFA's performance goals be extended to cover all FDA functions related to a drug's appearance in the marketplace, including monitoring direct-to-consumer advertising and postmarketing surveillance.
J.C. Penney Co. has restructured itself into a holding company. According to analysts, this move makes it easier for the retailer to spin off the Eckerd drugstore chain or to make acquisitions. However, Penney CEO Allen Questrom ruled out any immediate changes. He released this statement: "This structure, which is used by many companies with multiple businesses, creates a basic framework to facilitate organizational, operational, and strategic decision-making." The new structure would allow Penney to break out Eckerd's performance separately in quarterly reports. J.C. Penney acquired Eckerd in 1995.
Amgen's Neulasta (pegfilgrastim) is out of the gate. Made for cancer chemotherapy patients, the white blood cell booster is designed to decrease the risk of infection or febrile neutropenia in patients with nonmyeloid malignancies. A longer-acting form of Amgen's Neupogen (filgrastim), which is given as multiple injections every day after each chemotherapy cycle, Neulasta can be administered as a single dose per cycle. It comes in a 6-mg, single-dose syringe with a needle guard.
Latelines. Drug Topics 2002;4:7.