How FDA keeps doctors and patients in the dark (Daily Mail)


Imagine that you have cancer and are embroiled in the fight of your life.

Now imagine that the federal government is making that fight harder by gagging drug manufacturers from sharing information with your doctor and insurer about innovative, lawful treatments that could help save your life.

This sounds outrageous, yet it is a reality for many patients and their doctors, leaving doctors and patients in the dark about potential treatments.

About one in five prescriptions in the United States is “off-label,” meaning the medicine has been approved for use by the Food and Drug Administration, but the doctor prescribes it for a different purpose, patient population or dosage than the FDA approved.

But while doctors can legally prescribe off-label, federal law generally prohibits pharmaceutical companies from sharing information about off-label uses with doctors and insurers.

Companies face criminal prosecution and penalties from the FDA for “misbranding,” or communicating about off-label uses for a product outside of a narrow and often murky set of federal requirements.

As a result, doctors and patients are often unaware of treatment options that are lawfully available to them and, even if they are aware, the information they receive may be outdated.

Put simply, the government is censoring the communications of valuable information and could help improve — and even save — people’s lives. And these speech restrictions not only undermine patient care but they also violate the freedom-of-speech protections in the U.S. Constitution and state constitutions across the country.

The few courts that have directly addressed this issue have said that the Constitution protects a company’s right to share information about off-label uses.

Unfortunately, the FDA has developed a disturbing practice of settling these cases or otherwise preventing the courts…

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