WASHINGTON _ The Washington Legal Foundationhas filed a petition with the FDA which demands that theagency rescind its restrictions on what drugmanufacturers can put in advertising aimed directly atconsumers.
The FDA has 180 days to respond to the petition. If theagency does not drop its restrictions, which it is notexpected to do, the foundation said it will file a lawsuitasking the courts to determine if the restrictions violatethe manufacturer's right to free speech guaranteed by theFirst Amendment.
In a statement, Washington Legal Foundation counselRichard Samp said, "Consumer advertising plays animportant role in health care by making valuable medicalinformation _ such as symptoms which should bechecked out with a physician and symptomless conditionsfor which at-risk groups should be tested _ readilyavailable to consumers. Unfortunately, FDA has chosento erect needless barriers to advertising that hinder healthcare and violate First Amendment rights."
The foundation last year filed a lawsuit against the FDAcharging that its limitations on drug companies seeking todistribute information about off-label drug uses alsoviolate the First Amendment. That case will go to triallater this year.
This latest action by the foundation is expected tointensify the debate over how many restrictions the FDAcan place on what a manufacturer tells physicians abouttreatment outcomes and managed care plans about coststhe benefits of the therapy. FDA Commissioner DavidKessler has repeatedly indicated to Congress a lack ofinterest in compromise on the issue.
The foundation describes itself as a "national publicinterest law and policy center dedicated to promoting thefree enterprise system." One of its former lawyers, AlanSlobodin, now a staff member of the House CommerceCommittee, is heavily involved in writing FDA reformlegislation. n
-- Michele L. Robinson Washington Editor
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