Everyone knows the old saying about checking the fine print. And there is plenty of fine print in many of the printed ads for prescription drugs, of course. But what if that print was too small for some folks to read? Consider the many people who are older, regularly take medicine and, not coincidentally, may not have the best eyesight. This could become a prescription for mishaps… or something worse.
In hopes of mitigating the problem, the Pharmacists Planning Service, a non-profit that promotes health awareness programs, six years ago filed a citizen’s petition with the FDA and urged the agency to “immediately increase the print size on direct-to-consumer advertising.” The idea was to cut the potential for adverse events, harmful drug interactions and incorrect dosages, among other things (here is the petition).
This month, though, the FDA finally replied and rejected the request. While recognizing that “valid points” were raised in the petition, the agency responded by saying that current regulations already consider “readability” challenges and, moreover, a pair of draft guidances that were issued in 2004 and 2009 largely address the problem.
“We believe that the Food Drug & Cosmetic Act, the implementing regulations, published guidance and the availability of comment and advice from FDA provide sufficient and appropriate direction and flexibility for manufacturers to prepare DTC prescription drug brief summary materials that are readable and legible,” writes Janet Woodcock, who heads the FDA Center for Drug Evaluation & Research (here is the reply).
The 2009 draft guidance, for instance, notes that font size can affect readability and that the FDA has the right to object to differences in print size that might hamper patients, while also offering a few suggestions for manufacturers. And the 2004 draft guidance specifically recommends against using small print size in the brief summary section (you can read the guidances here and here).
But PPSI is perturbed. “How very, very sad that FDA would turn its back on millions of patients and consumers nationwide who can’t read the mouse print in the consumer press,” PPSI director Fred Mayer tells us. In his view, the draft guidances do not go far enough in so far as that the fine print remains small in many ads, suggesting the FDA has not moved to rectify the problem.
Nonetheless, PPSI is unwilling to give up. Toward that end, the non-profit has supported efforts by the California state senate majority leader to pass legislation that would require pharmacists to print specific items on a prescription label in a certain size typeface - 12 point, sans serif - so that patients would find the information easier to read (here is the bill).
If enacted, the bill will "keep patients safe and may potentially save lives," Democrat Ellen Corbett said in a statement yesterday after the bill passed the Assembly Health Committee. "This simple change will help many vision-impaired Californians, including millions of seniors that have expressed difficulty reading the current small print on their prescription labels.”
She noted that the state Board of Pharmacy four years ago did a survey and found that 60 percent of the respondents believe that larger or bolder print would make prescription labels easier to read (see this). Separately, the California Department of Aging has forecast that, between 1990 and 2020, the state population of those 60 years or older will increase by 110 percent.
Of course, California is just one state and there is no guarantee the bill will become law. Trade groups representing pharmacists, for instance, oppose the bill. But the legislative effort suggests the possibility that similar moves will occur elsewhere around the US and, eventually, lead to differing regulations. Meanwhile, the FDA has not finalized its draft guidances, leaving some seniors squinting for signs of relief.
STORY ENDS HERE