Healthcare group calls for ’off-label’ drug guidelines

NEW YORK: The Coalition for Healthcare Communication has released a position paper proposing new FDA guidelines for the dissemination of ’off-label’ information.

NEW YORK: The Coalition for Healthcare Communication has released a position paper proposing new FDA guidelines for the dissemination of ’off-label’ information.

NEW YORK: The Coalition for Healthcare Communication has released a

position paper proposing new FDA guidelines for the dissemination of

’off-label’ information.



’Off-label’ refers to drug uses (known as ’indications’) that are not

approved by the Food and Drug Administration.



If adopted, the coalition’s proposals will have a powerful impact on

pharmaceutical PR. ’We wanted to try to introduce some law and order in

the marketplace, so as to not give the FDA more ammunition in court,’

said Jack Angel, executive director of the coalition. ’We don’t want

them to be able to say, ’See what happens when you let companies push

unapproved uses for their products?’ ’



The group’s proposal follows a recent US District Court ruling which

held that existing FDA guidelines for promoting pharmaceuticals and

related provisions of the FDA Modernization Act (FDAMA) were

unconstitutional.



In a memorandum, US District Judge Royce C. Lamberth wrote, ’The

government, however benign its motivations, simply cannot justify a

restriction of truthful, non-misleading speech on the paternalistic

assumption that such restriction is necessary to protect the listener

from ignorantly or inadvertently misusing the information.’ The FDA has

appealed the decision.



Doctors are already allowed to prescribe pharmaceuticals for any use

they want, regardless of the indication for which it was originally

approved.



The district court ruling would allow manufacturers to more aggressively

encourage off-label uses of their products.



While this means more money for drug companies (not to mention for PR

agencies working with them), some experts argue it could also be more

risky for patients. Though some drug suppliers promoted off-label uses

before the ruling, Angel said they were ’doing this at some risk.’



According to Angel, the coalition’s guidelines interpret the court

ruling as allowing off-label promotion to physicians only - not

consumers. The guidelines call for the truthful dissemination of

information from peer-reviewed journal article reprints and textbooks.

The information must not be ’false or misleading,’ and it should

disclose ’the company’s interest in the drug and the relationship

between researcher, authors, publishers and companies.’



The coalition’s position also stipulates that promotional materials must

’state that the FDA has not approved the indication being

discussed.’



According to a statement issued by the coalition, this position is

supported by Washington Legal Foundation v. Henney, which held that

restrictions on the free flow of scientifically accurate information on

off-label use of approved drugs and medical devices contained in FDAMA

and FDA guidelines were unconstitutional. These restrictions severely

limited the dissemination of materials that contained discussion of

off-label uses.



’By allowing free scientific exchange while providing responsible

protection for integrity of the material, we ultimately improve patient

care,’ said Angel.



Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

Would you like to post a comment?

Please Sign in or register.