LATELINES

FDA mints new batch of products

Perhaps chastened by its lackluster drug approval record this year, the FDA has suddenly given the green light to a number of products. Among them are:

• Focalin (dexmethylphenidate HCl, Novartis) to treat attention-deficit/hyperactivity disorder. The company claims it's as effective as Ritalin (d,1-methylphenidate HCl, Novartis) but contains half the dosage, thanks to advanced isomer technology.

• Ortho Evra (norelgestromin/ethinyl estradiol transdermal system), the first birth control patch. Ortho claims it's as effective as the Pill but has the added advantage of once-a-week dosing.

• Xigris (drotrecogin alfa activated, Lilly), the first drug ever to be approved for sepsis. A recombinant agent, Xigris was found to improve the survival of patients.

• Tracleer (bosentan, Actelion Pharmaceuticals), a twice-daily pill for pulmonary arterial hypertension. The first in a new class of drugs called endothelin receptor antagonists (ERAs), Tracleer helped patients with this lung disorder breathe better.

• Invanz (ertapenem sodium, Merck), a once-daily IV or IM beta-lactam antibiotic for several moderate to severe infections associated with gram-positive and gram-negative aerobic and anaerobic bacteria.

• Dutasteride (GlaxoSmithKline) for benign prostatic hyperplasia. The 5-alpha reductase inhibitor does not have a brand name yet, since the company plans to apply for supplemental approval.

PhRMA sues Michigan Medicaid

PhRMA has sued to block Michigan Medicaid's plan to mandate price cuts from drug companies seeking to get on the state's Rx formulary. A P&T committee of physicians and pharmacists selected the "best in class" drugs by therapeutic category for the formulary. To participate in Medicaid, drug companies must match the lowest "best in class" price in the category. Doctors wishing to prescribe off formulary must justify their decision by phoning a bank of pharmacy technicians. Eli Lilly & Co., Johnson & Johnson, Merck & Co., Pfizer Inc., Pharmacia Corp., and Wyeth-Ayerst have refused to cut prices.

Prosecution: No bail for dilution case

The Kansas City pharmacist accused of diluting chemotherapy drugs phoned family members from jail to ask them to destroy evidence, according to a prosecution motion filed opposing bail. Robert Courtney has been held without bail since his arrest Aug. 15. He pleaded innocent to 20 counts of tampering with, misbranding, and adulterating two chemo drugs. Defense attorneys had asked the court to set bail, saying there is no evidence their client is a flight risk or a danger to the community.

FDA issued Florida drug dilution alert

The FDA alerted prostate cancer patients of a Pompano Beach, Fla., urologist who may have received diluted Lupron (leuprolide, Tap Pharmaceuticals). Investigators are trying to determine whether Victor Souaid, M.D., deliberately gave patients diluted doses of the expensive drug. The FDA offered to test patients' testosterone levels to determine whether they were given inadequate doses. Unlike a Kansas City pharmacist indicted for allegedly diluting chemotherapy drugs (see previous item), Souaid had not been charged at deadline.

Credentialing Web site upgraded

Pharmacists interested in earning disease state management credentials can now apply on-line at the upgraded Web site of the National Institute for Standards in Pharmacist Credentialing (NISPC). Pharmacists can earn a Certified Disease Manager credential in anticoagulation, asthma, or diabetes. The Web site, at www.nispcnet.org , also has information about the credentialing exams developed by NABP.

Maves to leave CHPA to take helm of AMA

Michael Maves, M.D., president of the Consumer Healthcare Products Association (CHPA) since Oct. 1, 1999, has been named executive v.p. and CEO of the American Medical Association, effective Jan. 15, 2002. According to a CHPA spokeswoman, a successor has not been named.

Drugstore chains sue over generics

CVS Corp. and Rite Aid Corp. filed suit in U.S. District Court, alleging that Bristol-Myers Squibb illegally kept generic versions of BuSpar (buspirone) off the market. The suit contends that BMS listed a new BuSpar patent with the FDA last year, one day before generic competitors were to be introduced. A court had ordered the drug removed from the FDA's patent registry last March. However, in October, a federal appeals court reversed the order that cleared the way for generic BuSpar but did not specifically require the FDA to force generic makers to pull their versions off the market.

Panel makes recommendations for enuresis

Expert recommendations for patient evaluation and treatment of primary nocturnal enuresis were published in the Oct. 12 issue of Infectious Diseases in Children. Sponsored by Aventis Pasteur, maker of DDAVP (desmopressin acetate), the panel discussed pharmacologic and nonpharmacologic management options. In addition to ordering moisture-sensor alarms that wake the child, pediatricians can also prescribe desmopressin, as well as the tricyclic antidepressant imipramine. The panel also urged evaluation of the bedwetting child's emotional well-being.

Schering launches PEG-Intron access program

Schering-Plough is launching the PEG-Intron Access Assurance program for PEG-Intron (peginterferon alfa-2b), a once-weekly injectable drug for the treatment of chronic hepatitis C. A company spokesman said the program will ensure that patients who start therapy will have the confidence of knowing the full course (48 weeks) is available. Patients must call an 800-number to get an enrollment number, which they must give their pharmacist with their Rx. The pharmacist must provide the patient's ID number to the distributor, who then calls a third party to place the order. The third party will check the number to see that the patient has enrolled in the program before shipping the medication to the pharmacy for the patient to pick up, according to the spokesman.

Flu shots safe for asthma patients

Influenza vaccines are safe for children and adults with asthma, regardless of the severity of the condition, according to a study by the American Lung Association's Asthma Clinical Research Centers Network. The study of 2,032 children and adults with asthma allayed concerns that flu shots might trigger dangerous side effects. Currently, only about 10% of asthma patients get flu shots, according to ALA.

Studies on DTC advertising give conflicting results

The 50 most-advertised prescription medicines accounted for almost half of the $20.8 billion increase in drug spending last year, according to a new study. The report was prepared by the National Institute for Health Care Management, a nonprofit research foundation founded by Blue Cross Blue Shield health insurance plan. In a separate development, Pfizer Inc. released two reports on DTC advertising. One report claimed there is no direct relationship between rising DTC advertising spending and drug prices. The second report, conducted in partnership with RxRemedy Inc., found that consumers who are prompted by ads to be more involved in their health care are significantly more likely to remain persistent with their therapy than are less-involved consumers.

Yet another DTC study, conducted by The Henry J. Kaiser Family Foundation, found that among the 30% of Americans who said they talked to their doctor about a drug they saw advertised, 44% said that the doctor gave them the Rx medicine they asked about.

Food stamps may soon be used to buy vitamins

The Senate Agriculture Committee recently approved a bill that would allow food stamp recipients to use their benefits to buy vitamin and mineral supplements. Herbal supplements such as ginkgo biloba and St. John's wort would not be covered under the measure, which was inserted into a farm bill by the committee's chairman, Sen. Tom Harkin (D, Iowa).

 

Judy Chi. Latelines for Dec. 10, 2001. Drug Topics 2001;23:7.