Recent cases of dangerous side effects in previously approved drugs demonstrate the importance of announcing full information about the safety of new drugs. For a long time, the United States Food and Drug Administration (FDA) was on the side of the manufacturer and did not disclose the data from clinical trials included in the requests for new drugs, considering this information as a "trade secret" and considering as the 'test data subject to protection as property of the manufacturer. "Even after the approval of a new drug application, the FDA only publishes summary data on the basis of which the approval was made. This generalized data does not contain complete information on the safety and effectiveness of the drug, moreover, a preliminary version of the document is often prepared by the manufacturer.

The situation is even worse when companies submit an additional request for a new drug, seeking approval for a new indication for a drug already on the market. If you look, the data from clinical trials demonstrating the dangers of the drug are not well known. Safety information in such situations can be very useful to the medical community, as doctors often use medication for indications not listed in the package leaflet before submitting an additional request for the medication or after refusing to 'approve a new one. testimony.

The American consumer protection organization Public Citizen, in accordance with the Freedom of Information Act, has asked the FDA to obtain data from post-market research on the safety and efficacy of certain drugs and products, including silicone breast implants, celecoxib and fluoxetine. However, these lawsuits have led to mixed results. In several cases, the information provided by the FDA has been shown to indicate a significant risk associated with the use of drugs, but the FDA, despite this, has approved the drugs. These drugs have been withdrawn from the market or warnings regarding their use have appeared only after tests or meta-analyzes were performed independently of the FDA and the manufacturer, which resulted in side effects associated with the drug and the risk of death.

Lawyers recommend that the FDA expand the routine practice of making safety information available on new drug applications. If the FDA does not follow this recommendation, Congress will have to pass legislation under which safety information will be made public. It is also necessary that the published aggregated data, on the basis of which the approval was carried out, be replaced by a more complete document, including all the safety information. A draft of this document need not be prepared by the manufacturer.