Drug makers, ad and media groups are urging easing of current DTC restrictions, contending there is no evidence that direct-to-consumer advertising causes overmedication. They see as too cumbersome the requirement that drugmakers run long lists of side effects in newspaper and magazine ads.
"Providing too much information ... can undermine the efficacy of the disclosure," warned the Magazine Publishers of America. "When the information is not readable and useful, it is less useful." MPA asked that the summary be shortened and its focus sharpened as did the Newspaper Association of America in its own comments.
The Pharmaceutical Research and Manufacturers of America called concerns that DTC ads will lead to overmedication "overstated and unfounded" and said Supreme Court decisions send a clear message that the FDA can't limit non-misleading speech, even if overmedication did occur.
"It is not constitutionally permissible to impose special restrictions on DTC advertising that is truthful and not misleading," the group said. "It is inappropriate in particular to restrict truthful and non-misleading communications to consumers based on a concern that the information will lead to improper drug utilization. It is simply not lawful under the First Amendment."
On the other side are consumer groups, some congressmen and medical groups who warn the FDA that by considering changes, it's toying with its mandate of protecting consumers.
"The administration is contemplating action that flies in the face of almost a century of documented harm ... from unrestricted promotional claims about health products," Sen. Edward "Ted" Kennedy, D-Mass., and Rep. Henry Waxman, R-Calif., along with two other senators and five other congressmen, wrote to the FDA. "History demonstrates that without pre-market safety and effectiveness requirements, deceptive, unsubstantiated claims proliferate at a tremendous cost in human lives. Post-market actions against misleading claims are incapable of protecting consumers from unsafe and ineffective products."
The legislators warned removing restrictions would lead to "many Americans" losing their lives. "Past abuse by those marketing products to improve health is more than sufficient to justify the constitutionality of the current protections."
The American Academy of Pediatrics called regulation of drug speech essential. "To open up the area of advertising to claims that do not have FDA scientific review jeopardizes public health and returns us to the patent medicine promotions of the turn of the last century," the group said.
Consumer group Public Citizen suggested that there are questions about effectiveness for drugs that the FDA satisfies, and that aren't answered in looking simply at what ads are misleading and fraudulent.
"Sellers can take advantage of uncertainty by making claims that are not certain to be true, but are not demonstrably or certainly false," the group said, suggesting that the FDA provides a key roles in evaluating whether messages are adequate and what constitutes "scientific truth."
AARP said the FDA alone is equipped to evaluate whether marketing claims have an adequate scientific basis, because consumers aren't equipped to make the evaluation. It also warned that there are big risks in the potential repercussions of letting marketers make ad claims that later are proved wrong.