[Jeffrey Roberts]

FDA to sweep unapproved drugs off the market Posted 1/9/2007 8:38 PM ETBy Rita Rubin, USA TODAYROCKVILLE, Md. â€" A Food and Drug Administration official on Tuesday told representatives of 65 companies selling unapproved drugs that the agency plans to step up efforts to remove such products from the market."We do intend to accelerate removal of unapproved drugs this year," Deborah Autor, director of the FDA's Office of Compliance, said at a day-long workshop about the routes makers of unapproved drugs can take to get the agency's blessing and avoid expulsion from the market.In September, a USA TODAY cover story pointed out that many doctors, patients and pharmacists are unaware that some medications on the market â€" nearly 2% of prescription drugs, according to the FDA â€" have never been scrutinized by the agency.The USA TODAY story spurred Sen. Chuck Grassley, R-Iowa, to write a letter to FDA Commissioner Andrew von Eschenbach asking for more information about how unapproved drugs end up on the market.They're sold as prescription and over-the-counter products for a range of ailments, including colds and coughs, hot flashes and pain. But consumers cannot be sure whether such medications are effective, let alone safe, Autor says.Companies that market unapproved drugs, many of which have been sold for years, argue that their products have stood the test of time. But, said Robert Temple, director of the FDA's Office of Medical Policy, "the fact that there's long-term use really doesn't tell you anything."Temple cited the case of anti-cholinergic sedatives, which had been used for years to treat irritable bowel syndrome. Eventually, the drugs were tested for that condition in large clinical trials, Temple said, and "every one of them failed completely."When one audience member asked why the FDA doesn't just ban all unapproved drugs, Autor said the agency instead is taking a "concerted and concentrated approach." She said, "We are constantly evaluating potential targets."One priority is getting unapproved versions of approved drugs off the market, Autor said.URL/Mutual Pharmaceuticals of Philadelphia waited nearly a year for the FDA to remove unapproved quinine products from the market before launching Qualaquin, its approved version of the drug, in July. Qualaquin is prescribed for malaria, but the unapproved versions were marketed for leg cramps and other uses as well as malaria.URL filed court motions in August against seven makers of unapproved quinine sulfate products, and all but one agreed to stop selling them by mid-November. Finally, the FDA announced last month that, because of safety concerns, it had ordered all unapproved quinine products off the market. Since 1969, the FDA said, unapproved quinine products had been linked to 93 deaths. Find this article at: http://www.usatoday.com/news/health/2007-0...drugs-fda_x.htmCopyright 2007 USA TODAY, a division of Gannett Co. Inc.

 

[Kathleen M.]

Here is the FDA main page on the unapproved drug issue. http://www.fda.gov/cder/drug/unapproved_drugs/default.htmFor some drugs there may be approved equivalents (I think some of the stuff recently approved for bladder control is basically the same kinds of anticholinergics as some used for IBS so may work if the ones traditionally used for IBS end up pulled).On the link there is a link to the database where you can look up drugs to see what is approved. It looks like Bentyl may be, but I couldn't find Levsin looking at the info I could find.K.

 

[jjohnson]

I'm a bit confused by this article. I thought that all the antispasmodics had been approved by the FDA at one time decades ago (for some indication or other), and that as ineffective as they are for IBS, using them for this condition is permissible off-label use.So I'm not really sure what point this Dr. Temple is trying to make with this example. I know that the makers of Pamine were reprimanded by the FDA for trying to market that product as an IBS drug, and the makers of Donnatal probably should be as well, based on what is written on their website. Companies that try to promote these as IBS drugs deserve to be punished, but they should be allowed to sell the products without making such claims. Again, I don't see what the FDA is getting at here unless they want to curtail doctors' right to prescribe off-label or else go after really ancient drugs like aspirin that pre-date the FDA itself.

 

[Kathleen M.]

Bentyl did show up on the list of drugs that were approved, Levsin did not. I'm not sure how old Levsin is as a drug. It is an herb-derived drug so it could be pretty old.I think some drugs were in use way before the whole you need to prove them safe and effective rules were inacted as they are today, so there seems to be a fair number of drugs that were grandfathered in as being able to be sold without the expense of doing all the tests needed for the FDA under the newer rules.I'm not sure the study that found that often antispasmodics were not that effective were done in a way that constitutes proof to the FDA one way or another (of if he is talking that meta-analysis paper, and that really isn't how you prove it to the FDA).The don't work for a lot of people, but they do seem to work well for some.K.

 

[17014]

Dear Pharma company Why do you develop drugs for women only???? There are also a lot men who suffers from IBS. Realy a lot. And the you guys from navortis, give me my money back, zelnorm did nothing for me.