The FDA Issues New Rules on Drug Marketing

     While the use of drugs for unapproved purposes is certainly nothing new, allowing such marketing with little or no oversight is a move that puts us all at risk. Luckily, these rules won’t go into effect immediately and are currently open for public comment. So, the solution is simple: Comment! In fact, don’t just tell the agency what you think, send a copy of your comment to your Congressmen too.

You can read the proposed rule here:

www.fda.gov/oc/op/goodreprint.html.

You can submit your comment here:

Docket Number FDA-2008-D-0053

To find your federal legislators, go to www.congress.org and enter your zip code.

Here are a few points that might help you formulate your comments:

     While the FDA wants to protect the off-label marketing of drugs, states and other federal agencies have gone after numerous drug companies accused of off-label marketing schemes.  Here are a few examples:
 

• 2003, Pfizer settled with the US Department of Justice for $430 million related to its marketing of the anti-seizure drug Neurontin.
• 2006, the Texas Attorney General’s office sued Janssen Pharmaceutical over allegations of illegal marketing practices related to the antipsychotic drug Risperdal.
• 2008, drug maker Eli Lilly is reportedly in settlement negotiations with the US Department of Justice over its marketing of the antipsychotic drug Zyprexa.  According to a recent article in the New York Times, Lilly could end up paying as much as $1 billion.
• Over 10 states have sued, accusing drug makers of off-label marketing.

 

     This proposed rule change puts patients at risk and violates even the most basic concept of informed consent. Does the FDA want you to have the benefit of the latest greatest wonder drugs? Or is it really about protecting an industry? The FDA’s rush to bring new drugs to the market has not resulted in better health for Americans:
 

• In 2004, the FDA added black box warnings to antidepressant drugs used in children.  Reported cases of suicide and suicidal thoughts as well as hostility and homicidal behavior had existed for over a decade before the FDA finally took a serious look at the problem.
• In 2006, the FDA finally warned about aggression, heart complications and psychotic behavior associated with the drugs used to treat Attention Deficit Hyperactivity Disorder.  This agency had been aware of potential heart risks and psychotic behavior associated with stimulant use for decades.
• The FDA has repeatedly come under fire for failing to adequately ensure drug safety.  Most recently, the FDA admitted it had never inspected a Chinese manufacturing plant that could be the source of a drug ingredient suspected of causing over 350 allergic reactions.
• The FDA does not have an accurate and dependable system of capturing adverse reactions to drugs. It is estimated that the FDA’s adverse event reporting system (MedWatch) only captures between 1% and 10% of adverse events.

 

     Encouraging drug companies to expand their off-label marketing efforts without rigorous safety testing could expose patients to even greater dangers.

     Take the time to submit your comments today. If you need more information a simple internet search on the FDA and drug safety or off-label marketing should be able to provide more than enough information. You can also read various CCHR publications on the dangers of psychiatric drugs at http://www.cchr.org/psychiatric_drugs/.