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SimplyThick - Not to Be Used in Some Infants
Parents and pediatricians are advised by the FDA not to use the thickening gel SimplyThick for infants born before 37 weeks. According to the FDA, 15 infants who had been given the product developed a life-threatening intestinal condition known as necrotizing enterocolitis; two of those infants died. The purpose of the thickener is to help those with swallowing problems keep their food down. For more information, please use the following links:
http://www.latimes.com/health/boostershots/la-fda-simply-thick-20110523,0,2269726.story
http://www.fda.gov/NewsEvents/newsroom/PressAnnouncements/ucm256253.htm
Colcrys and URL Pharma
Just a few weeks ago we had the uproar on the premature birth prevention drug Makena. Well, its d�j� vu all over again, but we have all been aware of it. URL Pharma took a long-used gout drug, colchicine, and ran its version through clinical trials, placed a brand name of Colcrys on it, and obtained FDA approval and three years of exclusivity. It set a much, much higher price for the new drug (more than $5 per tablet) than what the former version carried; the product is the same but now the patient has to pay for the government approved version, despite the fact it has been used safely and effectively for ages.
The pricing has been questioned from the beginning; now, however, four congressmen have written to URL's chief executive demanding some back-up for the company's higher price on a long-used drug. The documentation requested includes the cost of the trials necessary to win FDA approval, the marketing budget for the drug, its manufacturing costs, and projected sales and profits. The lawmakers are looking for a response by June 10.
http://blogs.wsj.com/health/2011/05/24/members-of-congress-ask-url-pharma-about-gout-drug-price/
Nuedexta Pricing Also Under Scrutiny
Congress hasn't limited their latest pricing crusade to URL Pharma's Colcrys. The same group of congressional members who wrote URL to question the pricing on its gout drug has also jumped on Avanir, whose Nuedexta drug is a combination of two longtime generics (quinidine and dextromethorphan).
Nuedexta won FDA approval last fall along with three years of exclusivity as a treatment for pseudobulbar effect, a condition in which patients lack the ability to control outbursts of intense crying or laughing (that may accompany neurological problems such as multiple sclerosis and brain trauma). The company has been asked to explain why these cheap generics, available for about $20 per month, cost $600 monthly when combined into Nuedexta.
http://www.fiercepharma.com/story/nuedexta-next-line-congressional-questions/2011-05-26?utm_medium=nl&utm_source=internal#ixzz1NZ6fgV8c
Sanofi Coordinated Senate Lobbying by Physicians
Sanofi gave millions of dollars to two medical societies which urged the FDA to delay approving a low-cost version of the company's blockbuster blood thinner Lovenox, according to a Senate investigation. Investigators for the Senate Finance Committee say Sanofi appeared to encourage the medical groups to write letters asking the FDA to block a generic version of the blockbuster drug, saying it might not be as safe as the original.
Documents obtained by investigators show that Sanofi donated more than $2 million each to the Society of Hospital Medicine and the North American Thrombosis Forum. The groups did not disclose the payments in their letters to the FDA last year.
http://www.pharmacistelink.com/index.php/drugs-and-treatment/30305
Kohl Urges Trade Officials to be Wary of Drug Industry Consolidation
Senator Herb Kohl, chairman of the Senate's antitrust panel, has urged the Federal Trade Commission to pay special attention to prescription drug shortages when weighing whether to approve pharmaceutical industry mergers. There have been at least nine megamergers during the past decade and a record 211 medications suffered shortages in 2010. Kohl suggested that the industry's capacity to produce vital medicines might have been hampered by a decade of industry consolidation. He also pointed to a 2009 government report that found that fewer drug companies competing in a therapeutic class may lead to fewer prescription drugs being developed and sold within that class.
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/162153-kohl-urges-trade-officials-to-be-wary-of-drug-industry-consolidation
http://pharmalive.com/news/index.cfm?articleID=782976&categoryid=9&newsletter=1
Misplaced Priorities and Resources? Raw Milk
Nearly all the milk sold to consumers in the U.S. has been pasteurized, and the FDA banned the interstate sale of unpasteurized milk in 1987. Questions arise on how aggressively the federal government should enforce it, and how many resources to devote to the task. There was a rally at the Capitol last week in support of an Amish farmer in Pennsylvania who is suspected of selling raw milk to customers in Maryland. The FDA has filed a 10-page complaint in federal court, seeking to shut the farmer down, after a yearlong investigation into his farm, which at one point culminated in a 5 a.m. "inspection'' by FDA agents, US marshals, and a state police trooper.
http://articles.boston.com/2011-05-23/bostonglobe/29575006_1_raw-milk-sale-of-unpasteurized-milk-fda-agents
Potatoes on the Chopping Block
In the last year, the potato has been marginalized by new school lunch rules, demonized by a popular television program, and blamed for the nation's obesity epidemic. Some in Washington now say they're fed up with the war on fries. In a letter to Agriculture Secretary Tom Vilsack this month, 40 members of Congress questioned his department's proposal to reduce the amount of potatoes and other starchy vegetables in school meals to about two servings a week, saying they can be a tasty, healthy way to provide potassium, fiber, and other nutrients at a low cost. "It's a great vegetable, and I don't know why we are picking on the potato," said Rep. Jean Schmidt, R-Ohio, who signed the letter. "I think this is very much an overreach." Other comments included, "The government shouldn't be telling kids what to eat" and "Should it be up to USDA to decide that potatoes can't be eaten responsibly?"
http://www.washingtonpost.com/politics/lawmakers-defend-french-fries-as-government-limits-potatoes-in-school-lunches/2011/05/18/AFuBmK6G_story.html
Niacin and Statin Clinical Trial Halted
The National Heart, Lung, and Blood Institute (NHLBI) of the NIH halted a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high-dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.
http://pharmalive.com/news/index.cfm?articleID=784229&categoryid=9&newsletter=1
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