DTC Drug Ad Text Is Too Hard to Read, Group Says

DTC Drug Ad Text Is Too Hard to Read, Group Says

June 26th, 2013 // 1:29 pm @

Latest FDA and cGMP Compliance News

We all have heard the expression that you need to read the fine print. And there is always a lot of fine print in many of the print ads for pharmaceutical products. But is that text too small for people to read? Many people who take the drugs are older and may have failing eyesight.

To possibly mitigate this issue, the Pharmacists Planning Service – a nonprofit organization that promotes more awareness of health problems – filed a citizen’s petition in 2007 with FDA and told them that they should order an increase in the size of print on all DTC ads. The thought was to reduce the chance for adverse events, improper dosages and bad drug interactions.

However, FDA has officially rejected this request this month. FDA stated that the group did make valid points, but current FDA regulations already cover readability issues. Also, FDA issued draft guidances in 2004 and 2009 to deal with this issue.

FDA stated that the FD&C Act, the guidances and the regulations give enough direction and flexibility for drug companies to prepare DTC ads that are both readable and legible.

The guidance from 2009 states that the size of font can have an effect on readability and FDA can object if the print size can make it harder for patients to read the text. The guidance from 204 recommends not using small print sizes.

The PPSI is not happy, however. It stated this week that it is sad that FDA is turning its back on patients who cannot read the tiny print in DTC ads. PPSI is not giving up either. It is now supporting efforts in the state senate in CA to pass a law that would mandate pharmacists print certain items on the prescription label in a 12 point type face. If it is enacted, it is argued that it will keep patients safe and save lives. A Democrat sponsoring the bill in CA said that a survey by the state board of pharmacy found that 60% of respondents thought that larger print would be easier to read.

This is only one state and there is no assurance that the bill will pass into law. Many trade groups that represent pharmacists oppose the law. But this effort shows there is a chance that such bills may be proposed in other states and could lead to different regulations on print size for DTC ads.

Subscribe Now

Featured Partner