Less than 2 weeks ago Wyeth filed suit against the FDA and a generic manufacturer of one of their drugs, so this makes 2 lawsuits against the FDA in a short period of time. Botox is being found to even have the potential to relieve migraine headaches, which has been in the news of late. 
The FDA claims they have received a number of warnings, which called for the Black Box warning which is now on the product as well. In Nevada recently they have made it illegal for medical assistants to administer Botox injections too. Allergan also has some new competition with Botox that sells for a cheaper price too. There are also studies going on with Botox being able to shrink a prostate gland too.
Botox gives grandmother her voice back
If off label use were to be changed, well we would see a lot more use in that area, and maybe a few less lawsuits. BD
The makers of Botox filed a lawsuit last week against the FDA, challenging federal regulations that ban drug companies from marketing drugs for uses that they have not been established as safe and effective through the FDA approval process.
Allergan Inc. filed the complaint Thursday in the U.S. District Court in Washington, D.C., saying that the FDA’s ban on “off-label” drug promotion by pharmaceutical companies violates their first amendment rights to free speech. The ban restricts Allergan from offering information about off-label use of Botox, an ant wrinkle drug that is used by many doctors for unapproved uses, such as treatment of muscle spaticity in children with cerebral palsy.
One of the most common off-label Botox uses is among children with cerebral palsy, who are given much larger doses of the drug. The toxin is used to prevent muscles from involuntarily contracting, helping alleviate stiff, jerky and difficult movements commonly associated with cerebral palsy.
Earlier this year, the FDA required a black box warning for Botox about the risk of serious injury or death if the drug spreads from the area of the injection to other parts of the body. The warning was issued after the FDA received a number of reports of Botox problems, most commonly involving off-label use at higher doses.
Drug Maker Sues FDA Over Ban on Offering Doctors Info About Off-Label Uses - AboutLawsuits.com
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