An investigation that lasted 15 months. Thousands of pages filed with the Internal agency enforcement records in which Henry A. Waxman, Democratic congressman of the United States, denounced numbers in hand an evident decline of the Food And Drug Administration.
The Food and Drug Administration (FDA) is the body responsible for the safety and efficacy of most foods, drugs (including veterinary), biological, cosmetic and radioactive products sold in the USA. By virtue of this role, when the food, pharmaceutical and biomedical industries violate the safety rules, the agency can officially recall them through an official document which is called a "letter of violation".
In reality, depending on the seriousness of the violation found, there are two types of letters that the FDA can send. The first is a "notice violation" in which the company is notified that there are irregularities; in this case the company is not required to respond or produce additional documentation: this is an invitation to remedy any errors or imperfections. A second letter is the "warning letter", a sort of last warning to which the recipient is required to respond with facts, that is by solving the infringements that are contested and producing documentation certifying the resolution of problems.
According to the report produced by Waxman in 2000 the agency sent 1154 warning letters, in 2005 it sent 535; serious violations of FDA-imposed rules would therefore have decreased by 54 percent. Other data also indicate that the number of products (drugs, or other implants) that have encountered problems after marketing that may even have led to withdrawal from the market have decreased by 44 percent. It would therefore seem that the FDA is doing its job admirably, which has the main purpose of protecting the health of citizens. Instead, a closer look at the FDA's internal documents reveals that in the last five years the headquarters has ignored many of the agents' indications by adopting a decidedly non-restrictive policy. For example, the number of warning letters has decreased because the number of notice violations has increased dramatically.
Suspicious cases that have turned into tragedy because they have resulted in the death of some patients have not been so rare; just remember the scandal of Vioxx or defective implantable defibrillators. As the article in the Lancet points out, public trust in the FDA has never been as low as it has been in the last five years, after the publication of this report it will be even worse.
Emanuela Grasso – Scientific Thought 10-07-06
Source.
Prescription for Harm: The Decline in FDA Enforcement Activity.
Is FDA going easy on violators? Lancet 2006;
