Drug Industry Proposal for Cough and Cold Medications Will Not Protect Children

For Immediate Release

Drug Industry Proposal for Cough and Cold Medications Will Not Protect Children

Statement of Peter Lurie, M.D., MPH, Deputy Director of the Health Research Group at Public Citizen*

WASHINGTON - Today, the leading manufacturers of over-the-counter cough and cold
medications indicated that they are "voluntarily transitioning" toward
putting a label on their pediatric products that instruct parents not
to give the medications to children under 4. This measure, announced by
the Consumer Health Products Association (CHPA), clearly represents a
political compromise, not a solution based on scientific evidence. It
will do little to protect all children from these ineffective and,
therefore, needlessly dangerous products.

By announcing a 4-year-old age restriction - halfway between the
current voluntary limit of 2 years of age and the age limit of 6
requested in a petition submitted last year - the manufacturers are
once again attempting to delay more definitive action by the Food and
Drug Administration (FDA). The FDA must use its authority to make a
strong, evidence-based decision not to allow these medications to be
available to children under 12, rather than let the industry engage in
this type of self-serving self-regulation.

A year after manufacturers of over-the-counter (OTC) cough and cold
medications agreed to voluntarily withdraw their products for children
under 2 from the market, a small Public Citizen survey found that less
than a quarter of cough and cold medications on sale in two major
pharmacies in Washington, D.C., and Baltimore, Md., carried labels
warning parents not to use these medications in children 2 or younger.
We have no confidence that today's proposed "voluntary" measures by
members of the CHPA (which does not represent all manufacturers of OTC
cough and cold medicines, particularly generic ones) will be any more
effective. Moreover, CHPA proposes to leave the medications on pharmacy
shelves "throughout the 2008-2009 cough and cold season," allowing the
companies to reduce their inventories.

By instructing parents not to give these medications to children
under 4, the new label sends the message that these medications are
"safe and effective" for children 4 and over. This assertion is not
true. Reviews by FDA Medical Officers and a more recent published study
demonstrate that OTC cough and cold medications have not been proven to
be effective in children under 12. In light of this ineffectiveness,
any toxicity is unacceptable. The FDA needs to take a firmer stance to
modify the regulations governing these products and must ensure that
they are removed from the market unless new evidence proves them safe
and effective. Unless the agency acts more expeditiously and
forcefully, we will continue to see more unnecessary emergency room
visits and deaths, and the annual squandering of hundreds of millions
of dollars.

*Last week, Dr. Lurie submitted testimony to an FDA advisory
committee on this subject. To read Public Citizen's recent testimony
before the FDA, go to http://www.citizen.org/publications/release.cfm?ID=7599.

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