Pros say ’wait and see’ as drug promo laws open up

WASHINGTON, DC: A recent District Court ruling has thrown open the door for PR firms to promote pharmaceuticals more aggressively - but healthcare pros are advising clients to take a wait-and-see approach before reorienting their marketing approaches.

WASHINGTON, DC: A recent District Court ruling has thrown open the door for PR firms to promote pharmaceuticals more aggressively - but healthcare pros are advising clients to take a wait-and-see approach before reorienting their marketing approaches.

WASHINGTON, DC: A recent District Court ruling has thrown open the

door for PR firms to promote pharmaceuticals more aggressively - but

healthcare pros are advising clients to take a wait-and-see approach

before reorienting their marketing approaches.



US District Judge Royce Lambeth ruled late last month that restrictions

placed on ’off-label’ information by the 1997 FDA modernization act

violated the First Amendment. The decision essentially revoked the FDA’s

power to restrict the dissemination of information from peer-reviewed

journal articles, reference textbooks and educational and scientific

conferences.



According to Ketchum VP for legislative and regulatory affairs Gregory

Fisher, the ruling ’will make prescription-drug promotions more like

over-the-counter-drug promotions. There will be more latitude in

relation to what you can say and how you say it.’



’This ruling opens up the market tremendously, but it’s questionable how

soon everyone will seek to take advantage of it,’ said David Gallagher,

Ketchum associate director for global healthcare.



While pharmaceutical suppliers and their PR firms will move slowly at

first (perhaps at the advice of their regulatory experts and attorneys)

they will eventually be more aggressive in promoting their products and

challenging those of their competitors.



According to Fisher, companies might even push the boundaries by sending

non-peer-reviewed material, such as letters to the editor, directly to

physicians.



Richard Samp, chief counsel for the Washington Legal Foundation, said he

expects the Justice Department to act at the FDA’s behest and seek an

appeal. This could delay the final resolution of the issue for as long

as two years.



While the government may also seek to prohibit Lambeth’s ruling from

taking effect until it is upheld by the appeals process, Samp doubts

such a request would be granted.



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