Pharmaceutical Companies Get More Leeway To Discuss Off-Label Uses of Drugs Under Bill

The debate over just what a pharmaceutical company can say about off-label use of its medications pits free speech rights against the FDA’s mission to protect the public, STAT reports. A bill introduced by Rep. Morgan Griffith, a Virginia Republican, would make it easier for drugmakers to discuss new “intended uses” for some drugs.

It’s something the pharmaceutical industry has long lobbied for, arguing that a proposed FDA rule that’s been discussed would, in effect, gag drug companies to prevent them from discussing some of the off-label benefits of their medications, even if such discussion would be to the public’s benefit. 

Griffith’s bill, called the Medical Product Communications Act, argues that it such restrictions hamper the healthy exchange of scientific information. Griffith said in a statement that the input from pharmaceutical companies will help doctors because they “often prescribe or administer therapies at different dosages or for other ‘off-label’ uses. Prohibiting manufacturers from responsibly engaging in a meaningful dialogue about such uses is not the right approach.”

As STAT points out such dialogue under Griffith’s bill would include: letters to the editor to defend challenges to research, disclosing a company’s research and development processes, making scientific results public, and disclosing outcomes and economic data.

Griffith said: “Doctors should have the most up-to-date information when caring for their patients and, when done responsibly and in an appropriate context, manufacturers should be able to provide it.”

There are many who do not support the bill, including Henry Greenspan. Greenspan co-founded a group called Justice in Michigan, which lobbies lawmakers to make it possible for people to sue pharmaceutical companies over the harmful effects of some medications. He tells STAT: “In my view, what we see in the proposed bill is pushing the boundary of meaningful pharmacological information (let alone, science) to the regulatory equivalent of ‘fake news’. If companies can use letters to editors to market drugs, they might just as well draw on the opinions of SNL’s Drunk Uncle.”

Source: STAT