McClellan pledges DTC clampdown
pharmafile | October 23, 2003 | News story | |
Mark McClellan the newly appointed FDA Chief Commissioner has pledged to clamp down on misleading US direct to consumer advertising by pharmaceutical companies.
Dr McClellan was responding to a report by the federal Government General Accounting Office (GAO), which found limitations in the FDA's monitoring of industry advertising claims.
"We do have the authority and we intend to use it", he said. "We will not be afraid to go to court when necessary".
The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) only monitors advertising that will have large audiences including all TV adverts and those most likely to mislead consumers.
The GAO concluded there was no fundamental problem with this system, but found new Government regulations introduced in January were now delaying the FDA's ability to have misleading adverts withdrawn as quickly as possible.
"Without more timely action, DTC advertisements that DDMAC has identified as misleading can remain on the air too long", the report noted.
It added that some pharmaceutical companies had repeatedly put out misleading advertisements for the same drug, while others were either late in submitting adverts for FDA review, or failing to submit them at all.
The pharmaceutical industry spent $2.7 billion on US DTC advertising in 2001, representing an increase of 145% since 1997, far outstripping the 59% growth in R&D spending over the same period.
Pfizer has been one of the companies most frequently found in breach of FDA rules, with its adverts for blockbuster cholesterol drug Lipitor ruled misleading four times in four years.
Nevertheless, Dr McClellan has defended DTC advertising, saying it encourages more patients with depression, hypertension and diabetes to seek medical help.
"We are not backing off on our policy of enforcing the law", he added. "If we see patterns of misleading advertising we are going to take more action".
He also reasserted the FDA's commitment to updating its drug approval process by reducing the cost and length of regulatory approval.
