Bill Vaughan, Senior Policy Analyst
For the Record
Senate Committee on Aging
September 29, 2005
The Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Healthcare Costs
Mr. Chairman, Members of the Committee:
On behalf of Consumers Union, the independent, non-profit publisher of Consumer Reports, we urge the Committee members to support major reforms in the advertising of pharmaceuticals. This is a major senior citizen consumer issue.
Specifically, we support legislation by Senators Grassley and Dodd (S. 930) that would, among a number of important safety provisions,
- Require review of advertising and promotional materials for new drugs for the first two years after approval and require improved risk communication to consumers in those materials; and
- Require review of advertising materials for drugs for which postmarket study requirements have not been fulfilled and require enhanced disclosures to the public about the safety uncertainties that may accompany the drug.
We have endorsed the call by Senator Frist, MD, for a two year moratorium on advertising of newly approved drugs. We hope the House of Representatives will consider legislation by Rep. Sherrod Brown that provides a two year advertisement moratorium on new drugs and gives increased authority and resources for the FDA to review and approve drug ads before they are made public.
Attached is a fact sheet we have prepared on why drug safety is especially important for seniors and how the elderly are disproportionately impacted by adverse drug events. Advertising of newly approved drugs that have not been adequately tested on seniors and those with multiple conditions has—and will in the future–result in harm and even death. Until we understand better the impact of a drug on a large and diverse population, its advertising should be limited.
Consumers Union has been working on this issue for a long time, with a June 1996 report and the attached February, 2003 report entitled, “Free Rein for Drug Ads? A slowdown in FDA review has left consumers more vulnerable to misleading messages.” This report details our analysis of FDA regulatory letters relating to ads, both direct-to-providers and direct-to-consumers (DTC), issued between January 1997 and November 2002. As you can see, we found a broad and disconcerting range of misleading messages: ads that minimized the product’s risk…; exaggerated its efficacy; made false claims of superiority over competing products; promoted unapproved uses for an approved drug; or promoted use of a drug still in the experimental stage.
A reading of recent regulatory letters seems to indicate that nothing has changed.
Companies are repeatedly warned about similar violations, all too often after the ad campaign has ended and the public damage done. In our 2003 report, we noted how the maker of Claritin had received a total of 11 regulatory letters about problems with their ads. With these kinds of repeat warnings, one gets the strong impression that many in the industry are just scoffing at the requirements, or as someone has said, ‘the FDA is just playing a game of whack a mole,’ as it tries to stop DTC and direct-to-provider abuses.
Our attached article documents why DTC is problematic. The recent Vioxx disaster reinforces our concerns. The Vioxx case example shows why drugs approved for a limited problem should not be mass marketed to hundreds of millions. If Senator Frist’s two year moratorium or S. 930 had been in effect, it is possible that the dangers of this drug would have come to light after use by a much smaller population. Thousands of lives would have been saved and tens of thousands of heart attacks avoided if the product had not been so aggressively marketed.
It is said that ads help educate the public about health problems—for example, the serious problem of depression that has often been tragically hidden in our society. Consumers Union believes that ads which explain a condition or problem and urge people to check with their physician have a role. Ideally, such ads would be run as public service announcements by CDC or NIH. But when the ads push a particular pill, serious problems can and do follow.
We also believe that advertising works to drive costs. Advertising increases sales of what are often the most expensive pills and thus accelerates the rate of health inflation which in turn compounds our nation’s health insurance and un-insurance problems. For example, the heavy advertisement of expensive brand drugs and their continued sales despite the availability of cheaper and comparable generics contributes to our nation’s health cost inflation.
Further, the drugs being promoted may or may not be the most effective and safest medicines. We believe that the government should encourage scientific, evidence-based studies to help the public understand which drugs are truly effective and safe. Therefore, we urge the Committee to continue to promote the Drug Effectiveness Review Project led by Oregon’s Health and Science University (and discussed at your July 20, 2005 hearing). This project is being used by 14 states to help develop their public program preferred drug lists (PDLs), thus ensuring that the most effective drugs are made available to Medicaid patients, state retirees, and others. A number of states have also shown how the use of these evidence-based PDLs can be used to save millions of dollars through competitive bidding procedures. Consumers Union has also tried to make this information about the most effective, safest drugs more available to the public through our Best Buy Drugs campaign (see enclosure), but we need help in spreading the word.
While the subject of your hearing today is DTC—the same types of problems are occurring in the direct to provider world, resulting in serious distortions in the quality of prescribing. We hope that you will also focus on this often hidden world where so many billions are being spent to influence prescribing physicians.
In conclusion, we hope the Committee will recommend legislation such as S. 930 and support Senator Frist’s call for a moratorium. This bill, and related proposals, would help improve the quality and safety of healthcare in the United States and moderate the rate of healthcare inflation.