The American Clinical Laboratory Association sent a letter to the FDA Sept. 18 calling the agency's recent regulations on reporting genetic testing results to patients "inappropriate" and "troubling."
In recent months, the FDA reportedly has tried to pressure genetic testing companies to stop offering patients test results that indicate how their genes may interact with specific drugs, according to STAT.
The trade group representing clinical laboratories said that the FDA has communicated different restrictions to various genetic testing companies. Some genetic testing companies are prohibited from reporting drug-gene interactions, while others are able to report predictions about the interaction.
The ACLA's letter says the FDA's regulations could stifle the growth of the genetic testing industry and make it harder for patients to get the correct medications.
However, the FDA argues it's acting out of concern for patient safety, according to STAT. It said it's worried that unsupported claims about gene-drug links could be dangerous if they encourage patients to start, stop or switch medications improperly.
The letter requests a legislative solution and a meeting between the ACLA and FDA.
Read the full report here.
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