Latelines for Oct. 7, 2002



Will Bush's nominee be a shoo-in at FDA?

National pharmacy associations look favorably on President Bush's nominee for FDA commissioner, Mark McClellan. Both NACDS and NCPA said they have worked with the physician-economist from Stanford University on a number of issues. He is "honest, fair, a man of character and integrity," said Larry Kocot, NACDS general counsel. Similarly, John Rector, NCPA general counsel, said he is more of a "consensus candidate" and would probably be "more respectful of the role of pharmacists." McClellan still faces Senate confirmation hearings before he can fill the void at the FDA.

User fees have pros, cons, GAO report says

User fees have allowed the FDA to review drugs more quickly, but more products have been withdrawn as well. That's one conclusion in a GAO report released last month and presented to the Senate Committee on Health, Education, Labor and Pensions. GAO believes the increased rate of drug withdrawals suggests the need for the FDA to step up its postmarketing surveillance activities. The FDA plans to spend about $71 million in user fees over the next five years to better monitor the safety of newly approved drugs and track their adverse effect rates. The extension of the Prescription Drug User Fee Act—which requires manufacturers to pay a fee to the FDA to speed the review of applications—for five more years became effective this month.

Bill to relieve R.Ph. shortage advances

The Senate Committee on Health, Education, Labor and Pensions has passed the Pharmacist Education Aid Act (H.R. 2173, S. 1806). The bill helps pharmacy students obtain loans and scholarships to pay for their education and helps pharmacy schools recruit and retain faculty by paying off loans of doctoral-level pharmacists who agree to teach for two years. Pharmacy associations are hoping the bill will next clear the Senate.

GAO recommends study on mergers, divestitures

Drugstores are one of four industries examined by GAO in a report released in September to Congress dealing with FTC decisions related to mergers, divestitures, and their impact on the retail market. The report concluded that there isn't enough information on how FTC's antitrust decisions are affecting the market. It recommended a study be undertaken to examine the impact of divestitures since 1994. Among other things, the study would explore whether smaller buyers continue to be as competitive as their larger counterparts in operating the divested assets. The other three retail industries GAO examined were supermarkets, funeral services, and gas stations.

FDA OKs first aldosterone-blocker for hypertension

The FDA has granted marketing approval for eplerenone (Inspra, Pharmacia) tablets, the first agent that selectively blocks aldosterone, for the treatment of hypertension. Eplerenone, which is generally well tolerated, is expected to provide benefit to a variety of patients. Clinical trials in approximately 3,000 patients demonstrated that eplerenone effectively lowers blood pressure, both alone and in combination with other antihypertensives.

Antibiotic gains new formulation, second copy

GlaxoSmithKline has won approval for Augmentin XR (amoxicillin/clavulanate potassium) Extended-Release Tablets. The antibiotic is indicated for the treatment of adults with acute bacterial sinusitis or community-acquired pneumonia. GSK stressed that two Augmentin 500-mg tablets are not equivalent to one Augmentin XR tablet because the dosages are different and the latter has a longer duration of action. Industry insiders claim the introduction is a way for the company to ward off generic competition for Augmentin. Besides Geneva Pharmaceuticals, which has a generic copy of Augmentin on the market, Ranbaxy Laboratories has just been cleared for a second version. Meanwhile, the New York United Teachers and the United Federation of Teachers Welfare Fund have filed a class action suit against GSK, alleging that it has engaged in unjust practices to suppress generic competition for Augmentin.

New Web site pitches generics

Blue Cross Blue Shield of Michigan has launched a Web site to promote the use of generics. Designed primarily for consumers, allows patients to compare the cost of brands versus generics, down-load a generics pledge card to show physicians that they prefer generics, and find out where they can obtain drugs at a discount. The site also has a spot for pharmacists to enter their e-mail address to receive alerts about drugs whose patents are about to expire.

FDA study faults compounded Rxs

Among 29 drug samples obtained from 12 compounding pharmacies that advertise on the Internet, nine samples were subpotent and one was contaminated with endotoxin, according to FDA researchers. The International Academy of Compounding Pharmacists did not respond to requests for comment on the FDA study presented at the recent annual meeting of the American College of Clinical Pharmacology.

Pharmacy pushes for new HIPAA standard

Urging quick action to meet the April 14 HIPAA deadline, four pharmacy groups asked HHS to replace its previously adopted Rx claim transaction implementation guide. The groups maintain that the current guide's optional patient information fields don't meet HIPAA's privacy mandate and will lead to lawsuits. After talks with PBMs failed, APhA, the American Society for Automation in Pharmacy, NACDS, and NCPA developed an alternative implementation guide without optional fields.

Generic version of Ortho-Cyclen approved

The FDA has approved Barr Laboratories' generic version of Ortho-McNeil Pharmaceutical's norgestimate/ ethinyl estradiol, 0.250 mg/ 0.035 mg oral contraceptive 28-day regimen (Ortho-Cyclen). Barr plans to market the drug, which it will launch immediately, under the trade name Sprintec.

Coalition calls for removal of nonoxynol-9

A coalition of more than 85 scientists and health groups is calling upon manufacturers of condoms and lubricants to voluntarily remove nonoxynol-9 (N-9) from their products. N-9 is the active ingredient in all OTC contraceptives and is added in smaller amounts to some sexual lubricants and to the outer surface of some condoms. The coalition is concerned that many people mistakenly believe N-9 provides extra protection against HIV and STDs, when studies show that it increases risk of infection when it is used rectally.

Pa. pharmacy school opens

The Lake Erie College of Osteopathic Medicine School of Pharmacy opened with an entering class of 83 students. Based in Erie, Pa., the private school has an accelerated three-year Pharm.D. professional curriculum, which will allow graduates to enter the profession one year earlier than traditional programs.

New program offers free drugs to indigents

Another pharmaceutical manufacturer is donating free drugs to needy patients. Under the Boehringer Ingelheim Cares Foundation's Patient Assistance Program, U.S. citizens or residents without prescription coverage who have an annual income equal to or lower than 200% of the federal poverty level can get a year's worth of nine free drugs. The nine drugs are Aggrenox, Atrovent, Combivent, Flomax, Mobic, Cafcit, Catapres-TTS, Micardis, and Viramune. For patients needing Viramune (nevira- pine), the annual income threshold is at or below $24,000 for individuals and at or below $40,000 for families of two or more. To access the one-page application form, call 1-(800) 556-8317.

Three substances placed in CS Schedule I

DEA has issued a final rule in the Sept. 20 Federal Register, temporarily moving three products into Schedule I of the Controlled Substances Act. The products are: N-benzylpiperazine (BZP), 1-(3-trifluoro-methylphenyl) pipera- zine (TFMPP), and 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7). DEA said placing these substances, which are often abused, into that category would avoid an imminent hazard to the public safety. Before this final rule was issued, DEA had given notice of its plan to make this move in the July 18 Federal Register (Drug Topics, Aug. 5).

California to give report cards on M.D.s, health plans

Beginning next month, California will provide consumers with a report card on physicians and health plans. The report card, which will be available at Walgreens in California, will rate 81 medical groups in 11 regions of the state, using a scale running from poor (no stars) to excellent (three stars) in four categories: overall rating, getting treatment and specialty care, communicating with patients, and timely care and service. The report card will rate the state's 10 largest HMOs with the same system. The categories include overall customer service, doctor communication and service, and how well the health plans help their members stay healthy or live with illness.

Remodulin therapy receives Medicare reimbursement

United Therapeutics Corp. announced that all four of the U.S. Medicare Durable Medical Equipment Regional Carriers (DMERCs) have now issued policies and procedures allowing for the nationwide reimbursement of Remodulin (treprostinil sodium) Injection therapy. Under each of the DMERCs' local medical review policy, Medicare coverage for Remodulin therapy is effective retroactively for all dates of service on or after May 21. In addition to coverage for Remodulin, Medicare will also provide reimbursement for the related infusion pumps and supplies. Generally, Medicare-eligible patients with all forms of pulmonary arterial hypertension for which Remodulin is indicated will be covered under the new DMERC policies.

FDA approves new indication for losartan

The FDA has approved losartan (Cozaar, Merck) for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with Type 2 diabetes and a history of hypertension. The FDA based its approval on the findings of the RENAAL study. The results indicated that losartan significantly delayed the doubling of serum creatinine and progression to end-stage renal disease (ESRD), although it had no effect on mortality. Losartan is the only drug to significantly reduce the risk of ESRD in patients with Type 2 diabetes, nephropathy, and hypertension.

FDA approves first nucleotide analog for hepatitis B

The FDA has approved the antiviral agent adefovir dipivoxil (Hepsera, Gilead Sciences) for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either elevations in serum alanine aminotransferase or aspartate aminotransferase, or histologically active disease. Adefovir is the first nucleotide analog to receive FDA approval for the treatment of chronic hepatitis B. According to the manufacturer, the drug was shipped to wholesalers during the last week of September.

ACCP hops on X12 bandwagon

ACCP has joined three other pharmacy groups in support of the X12 837 standard for billing pharmacist professional services. The X12 standard allows for the electronic submission of claims previously submitted on the HCFA 1500 paper form. APhA and ASCP had already climbed on board the X12 bandwagon launched last year by NCPA.

Bayer BP launches tamper-resistant packaging

Bayer Biological Products (Bayer BP) has introduced seal tabs on all boxes containing Gamimune N, 10%, Immune Globulin Intravenous (Human). The rollout of seal-tab boxes makes Bayer BP the first company in the biological products industry to introduce enhanced tamper-resistant packaging in response to concerns about product tampering. This innovation is the first in a multiphased program that will include additional measures and eventually extend to Bayer BP's other products. Bayer BP is also developing an educational component for healthcare providers and patients. The company's goal is to host Web conferences for groups of 25 to 30 physicians, pharmacists, or nurses about tamper-resistant packaging and how to identify packaging that has been tampered with.  

New indication approved for irbesartan

The FDA has approved irbesartan (Avapro) for the treatment of diabetic nephropathy in patients with hypertension and Type 2 diabetes, Bristol-Myers Squibb and Sanofi-Synthelabo have announced. The FDA based its approval on data from the Irbesartan Diabetic Nephropathy Trial (IDNT), which studied patients with hypertension, Type 2 diabetes, and evidence of nephropathy. Study investigators found that patients treated with irbesartan had a 20% lower risk of progression of their nephropathy compared with the placebo group, and a 23% lower risk of progression compared with patients treated with amlodipine (Norvasc, Pfizer).


Latelines. Drug Topics 2002;19:7.

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