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Medicaid covers many that existed before FDA tightened review in '60s
By Ricardo Alonso-Zaldivar and Frank Bass
Associated Press
Published on Monday, Nov 24, 2008
WASHINGTON: Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found.
Millions of private patients are taking such drugs, as well.
Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.
The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for the poor to pay for them.
The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold.
The AP checked the medications against FDA databases, using agency guidelines to determine whether they were unapproved. The FDA says there may be thousands of such drugs on the market.
Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid, which may be the biggest purchaser, keeps paying.
''I think this is something we ought to look at very hard, and we ought to fix it,'' said Medicaid chief Herb Kuhn. ''It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting the right set of services for beneficiaries.''
At a time when families, businesses and government are struggling with health costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.
Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.
Doctors surprised
That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.
The roots of the problem go back in time, tangled in layers of legalese.
It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were ''grandfathered'' under earlier laws, and even under the 1962 bill.
Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.
WASHINGTON: Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found.
Get the full article here.
Comments
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Posted 07:45 AM, 11/24/2008
That ain't what Kevin Trudeau said in his books...He blamed the FDA for the same thing, and said the FDA approved drugs that killed people just so some could make big money...so who is telling the truth...Kevin also said just stay away from perscription or shelf drugs and go organic...and stay healthy that way...
Posted 10:45 AM, 11/24/2008
none of this should be a suprise big bussiness has owned the government since 1937 .it is not in the best interest of these companies to stop making money selling garbage to the public. or end global warming and our dependency on fossil fuel even though the technology to do all that was common prior to the government being sold in 1937
Posted 12:28 PM, 11/24/2008
To Richard------- AMEN!!!
Green, OH
Posted 04:31 PM, 11/24/2008
What math wiz wrote this headline?
It is verified that 100 drugs on the market are not FDA approved. The FDA thinks there may be "thousands". So where do the "millions of drugs" come from? And they are responsible for "dozens of deaths" ?
