IM  

FOR IMMEDIATE RELEASE

Thursday 22 May 2008

CONTACT:

Adriana Surfas (DeLauro) 202-225-3661

Jeffrey Connor (Emerson) 202-225-4404

 

DeLauro, Emerson Press for

Responsibility in Drug and Device Ads

 

Washington , D.C. – Congresswomen Rosa L. DeLauro (CT-3), chairwoman of the Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, and Jo Ann Emerson (MO-8) introduced the Responsibility in Drug and Device Advertising Act of 2008, which would immediately implement safeguards in direct-to-consumer advertising following FDA approval of a new drug for sale.

While the full safety risks are often unknown for years after approval, pharmaceutical companies invest a great deal of money in the immediate promotion of approved drugs and devices, including billions of dollars in Direct-To-Consumer (DTC) advertising (an estimated $5.5 billion in 2006).

 “While we recognize the live-saving capabilities of new drugs and devices, the rush to promote new drugs and devices often occurs before there is any opportunity to examine potential public health and safety risks. This is about ensuring that physicians and patients have scientific evidence – collected from a larger population, rather than the small clinical trials – about the drugs and devices on the market,” said DeLauro.  “The FDA has important drug oversight responsibilities; and the push to promote new drugs and devices should not get in the way. Public relations should never trump public health.

 

"Judging the safety of prescription drugs and medical devices does not stop when the FDA approves their sale to the public. Accountability for a new medical technology exists as long as it's on the market and even after patients have stopped filling their prescriptions. Likewise, physicians, pharmacists and medical professionals want as much information as we can make available about the safety of the drugs and devices they recommend to their patients, and we have an ongoing responsibility to provide it. This bill represents the careful approach we need, especially when we have seen how hasty approvals and lax oversight have harmed patients," said Emerson.

At least one study has commented on how DTC advertising contributed to the overuse and misuse of Vioxx by both consumers and physicians, which led to an unnecessary increase in the number of people at risk of heart attack and stroke.  In addition to the safety concerns, DTC advertising of Vioxx increased costs to consumers and health plans alike, which were paying significantly more for a new drug that added little or no benefit for most people. 

In an effort to support the most critical aspects of drug safety at the FDA, the Responsibility in Drug and Device Advertising Act of 2008 would:

·      Establish a three year moratorium on DTC ads with a possible waiver if the Secretary agrees that the product is of affirmative value to public health;

·      Provides authority to require corrective materials to be distributed if the companies violate the advertising moratorium;

·      Includes strong civil penalties that apply to the first and subsequent violations of the ad provisions or other requirements of the Act;

·      Requires the advertising to prominently display information about the potential drug and device side effects;

·      Calls for a public education campaign on the risks of certain drugs.

 

The legislation will remedy problems that can emerge when post-market studies are conducted simultaneously with extensive advertising campaigns designed to maximize public consumption of the new drug – the promotion of Vioxx being but one example. FDA scientists have estimated that over 50,000 patients may have died from Vioxx side effects that may well have been diminished had promotion been delayed.