FDA Faulted / Human Drug Experimentation- Unapproved Uses, Drugs
FDA Faulted for Human Drug Experimentation – Unapproved Uses of Drugs
Off-label: the use of drugs to treat conditions other than the ones the drugs were FDA approved for Example: Geodon is a powerful antipsychotic drug. Against its own Medicaid rules, Florida wasted nearly $6.5 million tax payer dollars from 2003-2007 for this drug on kids despite the fact this drug is not FDA approved for children at all. Short clip here:http://www.youtube.com/watch?v=7ibwZJJXAWU Here is a snapshot (2005) of what Florida Medicaid was allowed to pay regarding antipsychotic drugs on children: www.psychsearch.net/atypicals.html
Associated Press FDA faulted over unapproved uses of medications By RICARDO ALONSO-ZALDIVAR July 27, 2008 WASHINGTON — When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.
The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as "off-label" prescribing.
Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.
What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.
Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.
The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.
The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.
The FDA "isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law," Grassley said in a statement. "As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished."
Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements.
The office tries to set priorities, by focusing first on misrepresentations that could have a damaging impact on human health. But the report found that the FDA lacks a system for tracking all the material it receives.
From 2003-2007, the office issued 42 notices of possible violations, which usually prompted the drug maker to drop its promotional claims. The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers.
An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify — approved to treat schizophrenia and bipolar disorder — for treatment of dementia-related psychosis and for use in treating children.
How much did your state get? Only 14 states to go – if dollar amounts are not listed for your state below, contact your own State Attorney General here: http://www.naag.org/attorneys_general.php , ask for the Media Relations person and then ask for the press release (or the settlement dollar amount) on the Bristol-Myers Squibb settlement for illegally promoting their antipsychotic drug Abilify for use in kids and the elderly. Then flip the press release to your local newspaper. Note: Alabama, Alaska, Mississippi, Pennsylvania, South Carolina and Wisconsin did not participate. Articles from each state here: http://tmap.wordpress.com Arizona ?
Arkansas $1.3 million
California $23 million
Colorado $2.6 million
Connecticut $1.9 million
Delaware $1.1 million
District of Columbia ?
Florida $21.5 million
Georgia $12.1 million
Idaho $1.7 million
Illinois $10 million
Indiana $2.2 million
Iowa $1.9 million
Kansas $3 million
Kentucky $3 million
Maryland $2.3 million
Massachusetts $9.2 million
Minnesota $4.35 million
Missouri $11 million
Nebraska $3.2 million
New Hampshire $1.2 million
New Jersey ?
New Mexico $1.3 million
New York $40 million
North Carolina $14.8 million
North Dakota ?
NYC $7.5 million
Ohio $6.5 million
Oregon $3 million
Rhode Island ?
South Dakota $700,000
Texas $15.7 million
Virginia $7.1 million
Washington $6.8 million
West Virginia ?
27,416 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html Video:http://www.youtube.com/watch?v=RfU9puZQKBY