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FDA attacked for "inventing" power

The FDA comes under fire as watchdog accuses it of acting outside its legal authority when writing warning letters to pharma companies.

A US watchdog has attacked the Food and Drug Administration (FDA) over the way in which it exerts its influence, claiming that the regulator has ìinventedî much of its power to police pharmaceutical advertising.

According to Conservative watchdog, the Washington Legal Foundation (WLF), the FDA acts ìoutside its legal authorityî when it writes warning letters about misleading advertising to pharma companies. The WLF also believes that such letters show a disregard for the First Amendment (where commercial speech is protected from governmental encroachment, but can be regulated if deemed to be deceptive) by alleging that materials are misleading without providing evidence to show how consumers understand them.

The watchdog believes that warning and untitled letters were invented by the FDA in the 1970s as a way of acting against a company without having to go to court. ëWith no judicial safeguards to protect against abuses, [the] FDA often uses warning and untitled letters to allege legal theories that are unsupported by the law and demand remedial actions that it lacks legal authority to require,í the WLF said in a statement.

The WLF has launched a new programme called DDMAC Watch to monitor the FDAís Division of Drug Marketing, Advertising and Communications (DDMAC).

DDMAC Watch has already challenged a letter from the FDA, to Lilly warning the company about its direct-to-consumer advertising for adult attention deficit hyperactivity disorder treatment, Strattera.

The FDA asked Lilly to withdraw TV ads for Straterra on the grounds that the graphics used made it difficult for consumers to understand the side effect warnings. Lilly agreed not to re-air the ad that had come to the end of its run.

However, in its letter, the WLF objected to the FDA/DDMACís failure to provide any evidence supporting its contention that the Strattera ad is misleading to consumers.

ìConsumers are active partners in their own healthcare and the pace of medical progress is rapid and hastening. The public must have access to the latest information on advances in patient care. Pharmaceutical companies are at the leading edge of medical advances and are ideally suited to disseminate high-quality information to patients and prescribers who need it,î said WLF chief counsel, Richard Samp.

ìDDMAC should start providing concrete guidance to industry to help them fulfil this objective and stop playing ëgotchaí with drug companies,î he added.

Lilly, which did supply a copy of the Strattera ad to the WLF but says it was unaware that the organisation would send a letter to the DDMAC, has until July 5 to respond to the FDA.

The FDA has declined to comment.

2nd September 2008

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