US label new rules change advertising style
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Editor's Note: The consumption of medicines is closely related to our health, but statistics show that less than 10% of doctors in the United States have a detailed interpretation of the labeling and instructions of medicines, which directly affects the safety of doctors' prescriptions. . In order to change this phenomenon, the US FDA recently made a major revision to the US drug labeling regulations to enhance the practical value of the label.
After more than five years of reviewing the drug labeling regulations, the US FDA made the most significant revision in 25 years. The new drug labeling rules stipulate that the label should clearly state the various information about the prescription drug, and introduce important information about the drug in the special area of the eye-catching area. With the relevant information, this new regulation will likely result in major changes in the advertising style of the drug and may provide certain liability protection for pharmaceutical companies.
Designed to reduce avoidable medication errors
In the press conference, Andrew von Eisenbach, the US FDA's acting director, announced the new prescription label label, saying that avoiding preventable medication errors is a major issue, and the new drug label is an important step towards this goal. .
Research shows that about 300,000 people in the United States suffer from medical errors every year, and nearly 100,000 people die. The square error is one of the main reasons.
Other studies have shown that less than one in every 10 doctors will read the drug label in their daily work. Even if doctors do read the drug label, they generally know very little about it. Although the US FDA has modified the drug label in the past, it has not been able to stop the dangerous habits of doctors.
Charles Gasson, a gastroenterologist in Manhattan, said: "I think the current drug label is really confusing. There are a lot of broken information, but it is not easy to find the information you need."
Janet Wood Cook, deputy director of the US FDA, said there are several reasons for drug label confusion. First, concerns about product liability and marketing have gradually made label writers no longer focus on doctors' education. Second, compared with 20 or 30 years ago, the medical community now has a better understanding of how drugs work in the human body, and most of this information must be included on the drug label. Third, there are far more drugs available than ever before, and doctors spend much less time on each patient than ever before.
US FDA officials estimate that the annual damage caused by medical errors in the United States is between $4 billion and $4.8 billion. These economic losses can be avoided by taking effective measures to provide doctors with better medical information, such as through prescription drug labels. The form of reform. FDA officials did not make a corresponding estimate of how many lives could be saved by a more succinct and clear drug label reform.
The new standard applies to new drugs approved within 5 years
The new labeling regulations will apply to the approval of all new drugs, as well as drugs that have been approved in the past five years, as well as those that are required to make major modifications to the drug label. Old drugs can circumvent these requirements because doctors are already familiar with the risks and benefits of older drugs.
The new regulations will make further efforts to make it easier for people to access medical information through computers. The new regulations will also encourage doctors to prescribe drugs online because all new drug labels are similar in structure and easy to search through the web.
First eye-catching area
According to the new regulations, a special eye-catching area will appear for the first time on the drug label. This area is used to briefly introduce some important information for the doctor to use when safely prescribing. This new area will set out safety considerations for the first time, followed by a brief description of any recent changes. Followed by advice on how to use the medicine and how many doses to use.
In addition, a new area will appear on the drug label, which will tell the doctor what kind of information they should provide to the patient.
The new regulations affect the folding drug inserts contained in some boxed prescription drugs, which can also be found in medical reference books, which are also referred to as "professional labels", "package inserts" or "prescription information". .
The information asymmetry of doctors and patients is further increased
However, the new regulations do not cover information sheets that are usually provided to patients by pharmacists. Relatively speaking, the supervision of these information sheets is much looser by the drug regulatory authorities, and these information sheets often do not include important medication considerations.
Sidney Wolf, director of the health research group of consumer interest group Public Citizen, called on the US FDA to make similar reforms to this information sheet. He said that the information obtained by doctors is relatively much better, and the information received by patients is extremely limited. The new regulations "expand the gap between the two kinds of information."
Drug advertising style may change
US FDA officials said that the introduction of new regulations may greatly change the way drugs are advertised. Small print ads that appear in newspapers and magazines that are detailed and difficult to read will most likely disappear, and will be replaced by shorter, clearer descriptions of common risks. Similarly, TV commercials may have to change their previous practices when discussing drug risks.
Once again, exempt from the pharmaceutical industry?
Some lawyers reacted strongly to the preface in the new rules, and they believed that the preface of the new rules transcended or replaced the liability law enacted by the United States.
In the foreword, the US FDA lists six external requirements for pharmaceutical companies. According to the new regulations, these requirements will be banned. One of the requirements is that pharmaceutical companies should place risk considerations contained elsewhere on the drug label in a prominent area of the label; another requirement is that the pharmaceutical company should list on the drug label that the US FDA considers it unnecessary Ming's precautions.
The preface states that “too much warning is just as inadequate as warning, and it will have a negative impact on patient safety and public health.”
Peter Barton Hurt, former General Counsel of the US FDA, said that over the years, FDA officials have made similar claims in some product liability trials, and the foreword to the new regulations may provide pharmaceutical companies with a wider range of Protection, which will make it impossible for the outside world to file a claim for liability.
Morris Singh, a Democrat from New York State and a member of the House of Representatives, said the liability clause set out in the new regulations states that "the FDA is once again defending the pharmaceutical industry."
The American Litigation Lawyers Association spokesperson Chris Matthew said the foreword is "the most shocking example of a pharmaceutical company gaining more power in our political life." Ms. Ma Xiu said that the US FDA has no power to issue such a disclaimer.