The US Food and Drug Administration (FDA) announced new regulations and review procedures designed to help generic drugs reach the market more quickly. Under a final rule that will take effect in August, brand name drug makers will be limited to a single 30-month stay of a generic competitor's drug approval while a patent challenge is resolved. Under current rules, brandname firms can request multiple, consecutive stays, leading to lengthy delays in the launch of generic competition. The rule also toughens the FDA's stance on the kinds of additional patents that brandname firms can list with the agency to gain more market exclusivity.
The new rule aims to keep brandname marketers from blocking generic competition by listing patents on drug packaging and "other minor matters not related to effectiveness," The FDA estimates that the updated regulations will save American consumers $35 billion over the next decade by cutting back on legal delays to generic drug launches. "These changes will enable consumers to save billions of dollars each year by making it easier for generic drug manufacturers to get safe and effective products on the market."
According to FDA figures, about 93 percent of current generic applications are rejected after a first review cycle and 66 percent also fail a second review cycle. Many of these applications are rejected during the initial cycles because they don't contain sufficient information, the agency said. FDA Commissioner Dr. Mark McClellan said other efforts will include development of new markers to evaluate generic equivalents for topical and nasal therapies, for which equivalence to branded drugs currently is difficult to prove.
Astra Zeneca to pay about Rs 1600 cr in Zoladex settlement
AstraZeneca said that it had reached a $355 million settlement with the U.S. Department of Justice over allegations that it illegally priced and marketed its cancer drug, Zoladex, According to the terms of the settlement, the drugmaker will admit to having violated the Prescription Drug Marketing Act. AstraZeneca agreed to settle without admitting liability and pleaded guilty to giving free samples of the cancer drug to urologists "with the understanding that some doctors would prescribe the drug to patients and bill Medicare, Medicaid and other federal health-insurance programmes for the cost of the medication," a news source reports. The resultant loss to these programmes was nearly $40 million, according to news sources.
The settlement ranks as one of the biggest Medicaid and Medicare fraud cases on record. TAP Pharmaceuticals in 2001 pleaded guilty to charges of giving away free samples of Lupron and encouraging physicians to seek Medicare reimbursement, news sources report. Their settlement carried an $875 million penalty. Bayer paid a $257 million penalty in a fraud case involving Cipro pricing and Medicaid. Similar investigations are also pending against Bristol-Myers Squibb and Schering-Plough, according to a news source.
US FDA Actions on Safety and Adverse Drug Events
Safety-related drug labeling changes for January 2003 have been posted on the MedWatch website. The following drugs had modifications to the CONTRAINDICATIONS and/or WARNINGS/BOXED WARNINGS sections:
conjugated estrogen tablets
thalidomide Capsules
metoprolol succinate Extended Release Tablets
mitoxantrone for Injection Concentrate
conjugated estrogens/medroxyprogesterone acetate tablets
sirolimus Oral Solution and Tablets
candesartan cilexetil Tablets
gemcitabine HCl for Injection
gemfibrozil tablets
Contraceptive patch to shake up UKmarket
The continuing rollout of Johnson&Johnson's Evra marks an important development in the $4 billion hormonal contraception market. Oral pills have dominated the market for more than 40 years, but with competitive pricing, convenient dosing and the support of family planning organizations, the consumer friendly patch could shake everything up. Johnson&Johnson's subsidiary Jansenn-Cilag staged the UK launch of the first contraceptive patch, Evra,. Applied to the skin, the 1 and 3/4 inch square patch releases a constant dose of hormones, estrogen and progestogen, through the skin to prevent ovulation. The patch has similar efficacy to the pill: it is over 99% effective in preventing pregnancy when used correctly. The key benefit is Evra's convenience of delivery and dosing. The patch is applied once a week for three weeks, with the fourth week 'patch free', so there should be less chance of forgetting to take a dose - a compliance problem that is common with the pill. It is hoped the product's potential for better compliance will help reduce the number of unplanned pregnancies.
New Website on drug information and quality issues
The United States Pharmacopeia Drug Quality and Information (USP DQI) programhas announced the launch of its new Web site www.uspdqi.org. The new Web site was created as a resource for people interested in drug quality and drug information and will provide vital information to those working in drug management programs worldwide. The Web site's focus is to provide information on priority medicines that are of interest to health care professionals working in developing countries. In addition, the site will discuss drug quality issues-focusing on substandard and counterfeit drugs.
The site features monthly drug information updates, USP DQI program news, monographs for essential drugs, and information on new drug therapies for diseases including HIV/AIDS, malaria, and tuberculosis. . USP DQI evaluates drug quality assurance systems and provides training in basic drug testing methods, good laboratory practices, and proper documentation to strengthen drug quality control labs. In addition, by working with national disease control programs, local universities, and health care organizations, USP DQI builds local capacity to monitor the quality of accessible products in a country and/or region.
First Biotech Asthma Drug
Xolair, which is given by injection once or twice a month, was developed by Genentech, the world's second-largest biotechnology company.An FDA advisory panel last month voted unanimously that Xolair's benefits in preventing asthma attacks outweighed its risks, which agency staff said could include a higher cancer risk. In studies, 0.5 percent of Xolair-treated patients developed cancer, compared with 0.2 percent of patients given a placebo, but there was no evidence linking the malignancies to the drug. Xolair works by disabling a naturally occurring antibody called IgE that triggers the release of chemicals that cause inflammation and provoke asthma and allergy attacks. "This is a drug that blocks the allergic triggers. Others just treat the symptoms."
The companies are seeking to treat moderate to severe allergic asthma in people over age 12.An FDA nod for Xolair could mark the first of three new drugs this year for South San Francisco, California-based Genentech. The company is expected to garner FDA approval for psoriasis treatment Raptiva before year-end and experimental cancer drug Avastin could get fast-track approval, also in 2003.
Red Ginseng May Help Treat Diabetes
The herb red ginseng may help normalize blood sugar levels in people with diabetes, two new studies suggest. But there is no way to know if the product you buy will be as effective as the preparation used in the studies, researchers cautioned. University of Toronto investigators presented both studies the American Diabetes Association's 63rd Scientific Sessions. In one study, people with type 2 diabetes who consumed ginseng and a highly viscous fiber similar to pectin had a notable reduction in blood sugar levels, reported Alexandra Jenkins, BSc, RD, a research associate at the University of Toronto.
In the second study, Korean red ginseng improved both insulin secretion and insulin sensitivity when compared with placebo, says John L. Sievenpiper, a PhD candidate at the University of Toronto. Ginseng, he said, appears to help the patients both to secrete more insulin and to process better the insulin they have. According to the American Diabetes Association, poor control of blood sugar can lead to severely debilitating and even fatal complications including cardiovascular disease, blindness, and kidney disease.
Baked or Fried Food Ingredient Mutates DNA, Study Finds
Swedish researchers caused a global furor in 2000 when they reported that acrylamide, used to purify water and in other industrial processes, could be found in a range of baked and fried foods. The chemical seems to be formed by exposing high-carbohydrate foods to high temperatures such as those used in baking and frying. Acrylamide can cause cancer in laboratory animals, but has never been linked to human cancer. In the new study, Ahmad Besaratinia and Gerd Pfeifer of the City of Hope National Medical Center in Duarte, California, found that acrylamide can mutate DNA in mouse embryonic cells. However, one study, published by U.S. and Swedish researchers last January, found no link between acrylamide consumption and the risk of bladder or kidney cancer. Acrylamide experts Fredrik Granath of the Karolinska Institute in Stockholm and Margareta Tornqvist of Stockholm University in Sweden, said the risk to any one person from eating acrylamide is small and they would not recommend changing nutritional guidelines.
New Research Targets Gut Hormones for Diabetes treatment
At a time when government researchers are predicting that one in three American children will develop diabetes in his or her lifetime, pharmaceutical companies are racing to develop therapies to stop the epidemic. Some are working on agents that attack the disease in new ways, while others are searching for new uses for drugs already on the market. Some of the hottest research focuses on a new class of agents dubbed the gut peptides. Unlike many of the drugs in development, these drugs work by a different mechanism than those now in use.
Development of the gut peptide drugs was a decades-long process that grew out of a better understanding of the body's gut hormones, which control everything from when we get hungry to when we push back from the table. By stimulating those gut hormones that suppress appetite and speed up metabolism and by blocking those hormones that stimulate hunger and slow energy expenditure, researchers reasoned, novel drugs could help obese people to lose weight, control blood glucose, and even improve insulin secretion and sensitivity. And early trials are proving them right.
The furthest along in development are the glucagon-like peptide-1 (GLP-1) drugs, which pack a triple whammy against the disease, stimulating insulin secretion, suppressing glucagon secretion, and inhibiting gastric emptying. The furthest along in its class is exenatide, a synthetic version of a GLP-1-like substance found in the saliva of the Gila monster. An open-label study reported at the meeting showed that about half of patients failing oral therapy achieved near-normal glycemic control when exenatide was added to their regimen.
There may be a fourth mechanism of action as well. Researchers at Novo Nordisk Pharmaceuticals, Inc., in Princeton, New Jersey, reported that their long-acting GLP-1 derivative liraglutide appeared to restore pancreatic beta cell sensitivity to glucose in patients with type 2 diabetes. In the study, insulin secretion after a single subcutaneous injection of the drug was similar in 10 patients with type 2 diabetes compared with that in 10 healthy controls.
Other researchers are targeting other gut hormones. Researchers at Stanford University reported that levels of ghrelin, a hormone thought to play an important role in both appetite and satiety, are significantly lower in obese insulin-resistant individuals than in equally obese insulin-sensitive persons. The results suggest that insulin may have a role in regulating body weight, via modulation of ghrelin, the researchers said.
Researchers from the Imperial College London in the U.K. reported on another gut hormone, oxyntomodulin, that is released into the circulation postprandially, in proportion to caloric intake. Carrying its message that food has been ingested, oxyntomodulin appears to send signals to the brain circuits that regulate appetite.
Not all the news centered on gut hormones. Researchers from the University of Texas Health Science Center in San Antonio reported that adding orlistat to a healthy diet and exercise program may help to reduce the risk of type 2 diabetes in an at-risk population. The four-year study showed that patients with metabolic syndrome who were treated with orlistat and healthy diet were 36% less likely to develop type 2 diabetes compared with those on placebo and diet.
Compiled from WWW By Dr VenkatAppaji Padmanabhuni Email: appajipv@hotmail.com