MENU

FDA

News

When Falsely Shouting "Crime" Pays by Francis J. Minton

Fixing How FDA Regulates Diagnostic Lab Tests

Roger Klein June 27, 2017
SHARE:      

Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing. Read an original approach to FDA regulation that Professor David Hyman and I published in Investor’s Business Daily.

  [Read More]

News

Prescription drugs pill bottle

Protecting Free Speech in Medicine

Christina Sandefur March 29, 2017
SHARE:      

Under federal law, pharmaceutical companies can be charged with a crime simply for telling a doctor about a legal, alternative use for an approved treatment. Sadly, government routinely censors the communication of valuable and truthful information that could help improve – and even save – people’s lives.

This changed in Arizona last week when Governor Doug Ducey signed HB 2382, a new state law that safeguards the free speech rights of those in the medical field to share truthful research and information about alternative uses for FDA-approved medicines. [Read More]

News

When Falsely Shouting "Crime" Pays by Francis J. Minton

FDA's Amarin settlement fails to establish clear guidelines for speech

Christina Sandefur March 18, 2016
SHARE:      

It’s a shame that in a nation that prizes free speech, the government routinely censors the communication of valuable and truthful information that could help save people’s lives. But it’s a fact.  Federal law strictly limits how pharmaceutical companies – those with the most knowledge about drugs and their possible uses and side effects – can share information about the legal "off-label" use of their products.

Last week, the FDA once again thwarted efforts to establish clear guidelines by entering into a settlement agreement in the Amarin case involving free speech and off-label advertisement. [Read More]

Executive Branch Review

When Falsely Shouting "Crime" Pays by Francis J. Minton

When Falsely Shouting "Crime" Pays

Francis Menton September 25, 2015
SHARE:      

In a huge 15 part series currently running at the Huffington Post, author Steven Brill accuses Johnson & Johnson of "crimes" and "illegal" conduct for its efforts to market the anti-psychotic drug Risperdal to FDA-unapproved populations. Brill appears completely unaware of the First Amendment to the Constitution, and that the Second Circuit Court of Appeals and Southern District of New York have held that the Food, Drug and Cosmetic Act must be interpreted in light of the Constitution as not criminalizing truthful statements by a company about its products, even if the FDA would like to prohibit those statements. It is the FDA that is behaving lawlessly. ... [Read More]