ARE OFF LABEL DRUG PRESCRIPTIONS SAFE?

WHO REGULATES. OFF LABEL DRUG USE?

If you are given a drug for a problem you have and it is listed as a drug for other illnesses and not your problem, it is called off label use.

Off label uses for drugs are not supported by good evidence. They account for 21 percent of all prescriptions written. Most of them werre for anticonvulsant and antibiotic use. 73% percent of them showed to have no scientific support. Atypical antipsychotic and antidepressants are used frequently without much evidence of success. Is off label use good for patients?

Since doctors are a free to prescribe drugs for any illnesses, this provides important advantages. A doctor can be different and innovative especially when routine treatments do not work. Patients are provided early access to drugs that might be valuable. It also allows doctors to apply new ideas on emerging evidence, and may the only treatment possible for unusual conditions.

But there are also negative consequences to off label drug use. Newer drugs used for off label illnesses certainly increase health costs. It also downgrades patient’s expectations of safety and effectiveness of the drug. Drug companies do not need to meet rigorous standards, and can seek secondary indications for illnesses that have had no clinical trials

CONFLICT IN USING OFF LABEL DRUGS

Insurance is paying for products that are not proven. Doctors want the freedom to try drugs on patients that were not made for their illness. It is hard enough to stay on top of rapidly evolving evidence. Big Pharma can also increase their profits by enlarging uses for their drugs.

We the public want safe and proven drugs that are also affordable. Yet we also want the newest therapies as long as supporting evidence is disclosed. The FDA does not want to strengthen its role in protecting the consumer. Despite the faith doctors and we place on the FDA.

WHAT COULD THE FDA DO?

Changes and labeling drug with black box warnings would be helpful. This would alert doctors that caution is required. Specific restrictions placed on drug usage would also help. Drug company’s marketing practices must be scrutinized.

Current FDA policy

The FDA is using a 1997 modernization act even though these regulations expired in 2006. The act prohibits promotion of products for unapproved uses. The FDA has drafted guidelines about the drug representatives passing out journal articles to doctors. These guidelines emphasize that the FDA action is not binding and suggests the FDA attitude is permissive toward off label drug usage.

The FDA no longer limits promotion of off label drugs that are being evaluated by the FDA. Big Pharma doesn't need to give the FDA and any advance review of the journal articles they distribute.

The drug companies use the ambiguity where FDA policy is not defined as a green light you use off label marketing. They use continuing education programs to promote off label use.

They encourage journal articles that promote off label usage and call it physician education. These articles and trials are drug industry sponsored and placebo controlled instead of comparing the drug with other approved therapies. Questions of off label prescribing often come from litigation rather than from FDA scrutiny.

Drug companies, by saying it is an infringement of commercial free speech, have challenged marketing drugs with restrictions. The FDA concedes the responsibility to the drug companies to regulate their own off label marketing. The FDA feels its limited resources could be best served by confronting other challenges.

What might the FDA do?

They could synchronize key evidence of these drugs use this and report on it. They could restrict marketing efforts that don’t have strong support. They could use active drugs has come persons with often label useless.

They could require also label uses to be presented at the same time the drug approval review of the FDA is presented. They could systematically collect data on drugs after marketing to check the harms and benefits of the use drug uses

The public is always pushing for improvement on drug evaluation after they come to market. Uncertainty about safety of drugs is only recognized after widespread use of these drugs tales of to help the patients.

Perhaps, with increased funding by Congress recently the FDA will step up to the plate and protect us the patients.

source NEJM 4.03.08

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