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Johnson & Johnson got word from the FDA that its cholesterol-lowering Benecol will receive fast-track review as a food. J&J's McNeil Consumer Healthcare originally wanted to market the spread as a dietary supplement. Now the product is expected to hit store shelves in early April 1999, about the same time as Take Control, a cholesterol-lowering margarine from Unilever PLC.

Food additives that would reduce food-borne illness will go to the priority track for the FDA's application process. Illnesses from E. coli, salmonella, cyclospora and other toxins cause an estimated 9,000 deaths each year in the U.S. alone. The FDA says the actual approval process will remain the same, no short-cuts, but the need for more such products is needed without the delay of waiting for non-safety products being reviewed first.

Monsanto Co. has the FDA's approval to market Celebrex but the drug's label must still warn about the possible side effects like bleeding ulcers. Consequently, the firm has kept pricing in line with current drug treatments on the market for rheumatoid arthritis. This requirement is disappointing to the firm and says it will also effect it's marketing efforts aimed directly at consumers.

Cooke Pharma Inc. has a new product called HeartBar that falls in a category of roughly only 200 other products. It is being referred to as 'medical food' instead of dietary supplement, thus, much less regulation is required from the FDA before the product can be marketed. Medical foods already on the market, however, have not been advertised directly to consumers as HeartBar will be. The product contains the equivalent of 16 heart dilator pills, L-arginine, and is claimed to improve circulation and reduce angina-like pain. HeartBar will be available in raspberry or vanilla flavors.

Monsanto's Searle & Co. drug unit will market its Cox-2 inhibitor for arthritis pain, but must include warnings about side effects, more warnings than the company had wanted. Even though the company performed its clinical trials on 15,000 people, many more than is typical or required, a federal advisory panel wants the company to warn about gastrointestinal problems. Every year between 10,000 and 20,000 people die from the use of painkillers according to the FDA.

The FDA granted Hoffmann-LaRoche approval to market Tasmar to treat Parkinson's disease in January 1998; however, there have been three deaths related to the drug's use. The company and the FDA have agreed upon very strict labeling to try to ameliorate the problem rather than taking the drug off the market entirely. The drug has been used by about 20,000 U.S. patients and about 60,000 worldwide.

Salt Lake City-based Anesta Corp. has obtained FDA approval for the cancer pain medication it calls Actiq. The product will be distributed by Abbott Labs beginning in March l999. Actiq is a lozenge on a stick that a cancer patient applies to the inner lining of the mouth to provide quick relief for 'breakthrough pain' which can occur several times a day between doses of other medications. Anesta expects sales could reach $10 million to $15 million in sales the first year.

The US Food and Drug Administration (FDA) has ruled that Johnson & Johnson's (J&J) Benecol products cannot be sold as a dietary supplement. The Benecol products are designed to reduce cholesterol in users. The FDA's decision is a serious setback for J&J which was planning to launch Benecol products beginning in January 1999. The FDA determined that the Benecol spread is a food product and that it cannot be placed in the dietary supplement category. To categorize the spread as a food product could lead to at least a six-month delay in its launch.

Johnson & Johnson is ready to test-market its cholesterol-lowering margarine in Portland, Oregon, by putting it on the shelves as a dietary supplement. The FDA, however, could seize the product from shelves or file a lawsuit against the company charging that the product is more than a dietary supplement, and falls into the category of food additive. If the company opts to file a special petition, then approval could take a very long time, perhaps years. J&J has several other products under review by the agency, one being a new treatment for MS.

London-based Zeneca Group PLC received U.S. FDA approval for its breast cancer drug Nolvadex for use with women in the high risk category for acquiring the disease. Generically known as tamoxifen, the drug has side effects such that the FDA recommends only high risk women be given the option. Tests on this drug and raloxifene will continue.

Sound-alike or look-alike drug names have contributed to an average one death per year in the US. One lawsuit alleges that a physician's handwriting is to blame. The problem of naming drugs is becoming greater all the time. Organizations concerned include the FDA and the Institute for Safe Medication Practices as well as pharmacists. New methods of naming and checking the names are being used, but the problem is not completely solved. Examples include Evista/E-Vista; Premarin/Primaxin; Imferon/Interferon.

CollaGenex Pharmaceuticals Inc.'s Periostat drug is expected to win the approval of the Food and Drug Administration (FDA) during the second week of October 1998. Periostat is a low-dose version of doxycycline, which is designed to fight periodontal disease. The drug can lessen the need for continuous bacterial cleaning treatments at the hands of dentists. Periostat can also stop periodontal disease from spreading.

Scientists at Brookhaven National Laboratory in Upton, N.Y. found Hoechst Marion Roussel's drug Sabril blocked the effects of cocaine by nearly 50% in rats without major side effects. The drug also stopped animals from seeking out the addictive drug. Sabril is an epilepsy drug widely used in Europe and awaiting approval in the U.S. Dr. Dewey, a scientist and Brookhaven, wants to start clinical tests on cocaine addicts as soon as the drug is approved. There are currently no medications to treat cocaine addiction.

The Food and Drug Administration has received about 100 reports of men suffering serious adverse reactions or dying after taking Viagra, an impotence drug, but regulators remain convinced that it is safe. Rather tnan track all reactions, the government searches for signals that a drug may cause unusual effects on patients. As of mid-June, the FDA has received about 30 reports of men dying after taking Pfizer Inc.'s drug.

The government received a recommendation from a federal advisory board to approve the first Lyme disease vaccine. Lyme disease affects thousands of people annually. SmithKline Beecham PLC's LYMErix could be used to protect people, between the ages of 15 and 70, against Lyme disease. The advisory panel determined that the vaccine does satisfy the Food and Drug Administration's (FDA) requirements, but that the vaccine should continued to be tested for safety.

The Food and Drug Administration (FDA) announced that a popular dietary supplement, called Cholestin, is an unapproved treatment. The drug, made by Pharmanex Inc., is said to lower cholesterol levels. The FDA's ruling amounts to the prohibition of the sale of Cholestin. The FDA and the pharmaceutical industry are struggling to define cases where dietary supplements are in reality, medications.