Latelines for Nov. 18, 2002
Purdue Pharma will give Florida up to $2 million to develop a software program to monitor controlled-substance scripts. Florida will then make the program available free of charge to other states. The program will track a patient's prescribing history in real time to help stop doctor shoppers. Florida will also use a $150,000 Purdue Pharma grant to fund five law enforcement seminars on drug diversion.
With the Republicans having won control of both the House and the Senate, community pharmacy leaders are concerned that Congress will adopt legislation putting pharmacy benefit managers in charge of the Medicare Rx benefit President Bush has targeted as a top priority. The November election results find both NCPA and NACDS ratcheting up their lobbying efforts to prove to Congress that PBMs are bad medicine for seniors.
The FDA has approved atorvastatin (Lipitor, Pfizer) for the treatment of familial hypercholesterolemia in children 10 to 17 years old. The agency has also approved cetirizine (Zyrtec, Pfizer) for the treatment of year-round allergic rhinitis and chronic idiopathic urticaria in infants six months of age or older. Cetirizine is the only antihistamine approved for use in this age group. Cetirizine is also approved for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria in children two to 11 years old.
In New York State, new Medicaid prescriptions for brand drugs that have generic equivalents will require prior authorization under a requirement of the state's Medicaid program scheduled to take effect on Nov. 17. Physicians who want to prescribe for a Medicaid patient a brand drug for which a generic is available must call a designated hotline and justify the exception to obtain Medicaid coverage. The generic drug mandate implements a law passed by the state legislature in January. Only brands that have an "A-rated" generic versionconsidered by the FDA to be therapeutically equivalentare subject to the mandate.
GenPharm has received approval to sell a generic form of Roche's Accutane (isotretinoin) for recalcitrant acne. The Toronto firm must take the same safety precautions in marketing the drug, which has been linked to birth defects and suicide, as Roche currently does. Among the risk management steps Roche takes are limiting prescribing to registered prescribers and requiring pharmacies to dispense the drug only if the Rx bears a yellow sticker from the doctor signifying that the patient has tested negative for pregnancy and has agreed to use birth control. While the risks associated with Accutane are well known by now, drug safety experts fear that the same is not the case with the new product under its generic name. They stress that an equally vigorous public awareness campaign must be mounted with the generic product to avert adverse events.
Longs Drug Stores has introduced Longs Senior Advantage, a program designed to provide senior citizens with more affordable health care and savings on a wide variety of products and services. Launched Nov. 1 at more than 440 stores, Longs Senior Advantage is available at no cost to senior citizens who pay cash for prescriptions and either meet the age require- ments or are eligible for Medicare. Plan members also receive a 10% discount on more than 1,500 Long's private-label products, all Hallmark products, and Long's One-Hour Photo processing services.
If Congress does not fix the average wholesale pricing (AWP) system for Medicare-covered Rx drugs, CMS will. So said Tom Scully, administrator of CMS, in testimony to the House Ways & Means Subcommittee on Health. Scully said CMS will ask one of the 23 Medicare Part B carriers to determine a fair price during the next six months. A fair price would incorporate a service component.
The USP verification program, which will begin certifying dietary supplements this year, may not be in the best interest of consumers and may confuse consumers, according to the Center for Science in the Public Interest and the National Consumers League. The groups argue that while verification by USP guarantees the amount of an active ingredient contained in a supplement, as well as its freedom from contamination, the labeling does not certify that the product is safe or prove that it is beneficial.
NABP has raised the fees for the NAPLEX and Multistate Pharmacy Jurisprudence Examination, effective New Year's Day. The new NAPLEX fee is $430, up 19%. The MPJE will cost $170, a 31% increase. The fee hikes are due to higher costs charged by the firm administering the tests, according to NABP. For more information, go to www.nabp.org .
The FDA has approved a testosterone replacement therapy gel (Testim, Auxilium Pharmaceuticals) for the treatment of low testosterone levels. The novel topical formulation supplements low levels of testosterone in men. The FDA based its approval on the largest clinical trials ever conducted in testosterone replacement therapy. The studies involved 644 hypogonadal men treated at more than 70 centers in six countries. The manufacturer found that Testim normalized testosterone levels and improved sexual dysfunction and other symptoms associated with low testosterone. The company's development program for Testim also included the largest placebo- controlled testosterone replacement trial ever conducted, with more than 400 patients enrolled at 43 centers throughout the country. Regulatory clearance for Testim was received only 22 months after initial product development. Testim is Auxilium's first commercial product.
Cardinal Health's plan to buy Syncor International is in danger because Cardinal discovered Syncor officials made possibly illegal payments to customers in several foreign countries, including China and Taiwan. Syncor, Woodland Hills, Calif., is a nuclear pharmacy company.
The FDA has approved pravastatin (Pravachol, Bristol-Myers Squibb) for the treatment of heterozygous familial hypercholesterolemia in pediatric patients eight years and older. This new indication offers an additional treatment option for children whose LDL cholesterol levels exceed acceptable limits following an adequate trial of diet modification. The FDA based its approval on the results of clinical trials that Bristol-Myers Squibb conducted at the agency's request. In return for complying with this request, the company was granted a six-month extension to its pravastatin exclusivity, through April 2006.
Schwarz Pharma, a wholly owned subsidiary of Kremers Urban Development Co. (KUDCo), has received final FDA approval to market its 10- and 20-mg strengths of omeprazole, the generic version of Prilosec, manufactured by AstraZeneca. The approval follows an agreement with Andrx Pharmaceuticals and GenPharm Inc. In accordance with the agreement, Andrx and GenPharm have relinquished their six-month marketing exclusivity, allowing the FDA to issue final approval for KUDCo's version of Prilosec to be made available to U.S. consumers. Impax Laboratories has also been granted approval by the FDA to market 10- and 20-mg strengths of omeprazole as well as tentative approval for its 40-mg strength of the drug.
Marina Marketos. Latelines. Drug Topics 2002;22:4.