Thursday, March 10, 2016

Small Free Speech Victory

The 3/8/2016 New York Times reports, "FDA Deal Allows Amarin to Promote Drug for Off-Label Use".

This is a small but potentially important victory for drug company free speech rights.  As the articles notes:
The agreement settles a legal case between the agency and the company, Amarin, a small drug maker that sued the F.D.A. last year for the right to promote its only product, Vascepa, to a broader range of patients. In August, a federal district judge in Manhattan ruled that the F.D.A. could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company’s right to free speech.

The final settlement is still subject to approval by the court.

The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.

But some legal and drug-safety experts said the settlement could encourage other companies to seek similar arrangements and, ultimately, have profound implications for how drug makers sell their products...
Clearly, the FDA wishes to keep the scope of this as narrow as possible.  On the other hand, many free speech advocates would like to see this principle applied more broadly.

And if any companies would like to further pursue this kind of free speech fight, they should contact attorney Jim Manley of the Goldwater Institute. Manley and the Goldwater Institute have urged policy changes in this area and are exploring litigation.

(Related story from last year: "Free Speech 1, FDA 0".)