Jan 19, 2019 | Updated: 08:39 AM EST

FDA Proposes Letting Drug Companies Undermine Official Safety Warnings

Mar 17, 2015 12:32 PM EDT


The Food and Drug Administration has now proposed the drug companies to undermine their own official safety warning in their sales presentations to customers.

It is obvious that an FDA warning about the use of a drug can scare off buyers, but according to the recent FDA's proposal, drug manufacturing companies would be able to provide doctors, hospitals and other customers with information that might conflict with the official FDA advice about their products.

This proposal has got the support of the pharmaceutical manufacturers. They claim that if the proposal is accepted, the new policy would allow them to present the doctors, the hospitals and other customers with the latest research and studies.

It might sound great, but this proposal has already gotten raised eyebrows because the public health advocates think that the drug companies can easily mislead the customers by providing only selected information from the latest studies. According to the Washington Post, most of these individual studies differ widely in their results, and many of them are funded by the industry.

The founder of Public Citizen's Health Research Group, Sidney M. Wolfe, says that "The proposal seriously undermines FDA authority. Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be."

According to the Washington Post, the FDA clearly mentions under its new proposal that it would not "object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling." It also mentions that all the studies must be well designed and should as informative as the data sources that the FDA used in generating the official warning.

The approval of this proposal means an increase in the drug sales and also lessening the FDA warnings, instead of heightening them.

It is also mentioned that the new information or studies should come from peer-reviewed academic journals, but according to the critics, most of this research already suffers from industry bias, which means that the drugs might be explained/advertised as less harmful than the FDA's warning, which could potentially endanger the patients.  

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