On
September 2, 2003, FDA concluded the public comment period on the
usefulness of printed patient information for prescription drugs
(Docket No. 03N-0168) and is expected to respond in coming months
prospectively through guidance to industry or a rulemaking that could
change printed patient information for years to come. The
PPLA weighed in on the issue filing comments with FDA in late
August. Our comments are posted above, as well as under News
and Resources.
The issue cuts to the core of the
PPLA's risk communication mission. We are
rallying our trade group's members to join in a nationwide call
for FDA-approved,
manufacturer provided, printed patient information for prescription
drugs. To this end, we have attended FDA-sponsored meetings,
presenting our position to industry leaders, and continue to
correspond with FDA regarding Docket No. 03N-0168 with FDA.
The
issue of useful printed patient information for Rx drugs was taken
up by Congress with the 1996 passage of the Health and Human Services (HHS)
FDA funding act (Public Law 104-180).
It requires more, and more useful, written information be
made available to drug end-users. The law blocks FDA from
regulating patient drug inserts, only allowing the Agency to
monitor private sector progress in meeting goals, and to take
corrective action if the standards are not being met.
Specifically, the law requires that, by 2006, 95 percent of
individuals filling new prescriptions will receive useful written
information.
However, a 2001 FDA-commissioned study found that only
about 50 percent of patients had received useful information.
An FDA Advisory Committee, concerned that private industry was not
on track to achieve the Year 2006, urged FDA to take action as
called for in Public Law 104-180.
These shortcomings were addressed by industry, trade, healthcare
and public interest groups, including the PPLA, at FDA's July
public hearing in Washington, D.C. It is unclear what, if
any, corrective action FDA will take at the end of the comment
period. It is clear that the Agency is under pressure on
many fronts to seriously consider and implement regulations requiring patient
friendly, FDA-approved and manufacturer-produced printed information for all Rx drug
products.
The PPLA endorses that regulatory outcome.
