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Drug Maker Asks For FDA Drug Ad Reviews

Apr 28, 2008 | Parker Waichman LLP

Earlier this month, members of Congress asked the Food and Drug Administration (FDA) to move faster in forcing drug companies to include safety-reporting information in their television and radio ads.  Now, drug maker AstraZeneca Plc is urging U.S. lawmakers to revive a program for drug makers who want to voluntarily submit their television commercials for regulatory review.  Congress created the program last year but it has not taken effect and lawmakers failed to give the FDA full authority to collect and spend industry fees that would fund the reviews.

Lawmakers are looking for those "direct-to-consumer" advertisements that appear during nightly news and other broadcasts to include information advising consumers how to report potential drug side effects to the FDA, which tracks drugs’ adverse events and uses reports from doctors and patients to be alerted to potential safety problems with drugs currently on the market.  Because the system is voluntary, FDA scientists are concerned it misses most adverse drug reactions.  "When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing," said Representative Rosa DeLauro, Democrat-Connecticut, who chairs the House sub-committee controlling the FDA's budget.  "Consumer reporting is an alarm system," says Representative Jan Shakowski, Democrat-Illinois.

AstraZeneca wrote to four senior lawmakers asking that they urge their colleagues to provide the necessary FDA power to initiate the effort.  "Without such resources, (FDA's advertising division) cannot timely review ads and some biopharmaceutical companies, regrettably, may forgo advisory reviews," AstraZeneca wrote. If Congress does not fully authorize the industry fees, AstraZeneca urged the lawmakers to add more taxpayer funding for FDA ad reviews.

Some lawmakers oppose having the industry fund more FDA activities.  Drug and medical device makers pay hundreds of millions of dollars annually for product reviews and some critics feel the funding may pressure FDA staff to act in the interest of companies, not consumer.  Pharmaceutical companies pushed for the ad-review program to address criticism that their widespread promotions led to unnecessary prescribing.  Some companies submit their commercials to the FDA for review now, but staff to evaluate the ads is limited.

A law enacted in September 2007 requires print drug ads to state, "You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088."  Currently, broadcast ads have no requirements to carry the statement.  In late December, the Consumers Union petitioned the FDA to require the statement on TV and radio drug ads.  Direct-to-consumer advertising drives billions of dollars in US sales and studies find most television prescription drug ads minimize risk information.  Prescription drug ads began being run on the air just over a decade ago, but a recent study finds most do not present a fair balance of information, especially when it comes to drugs’ side effects.

The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required that the companies present a fair balance between information about effectiveness and information about risk; however, fair balance is not defined by the FDA.


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