The federal government urgently needs to beef up its regulation of direct-to-consumer advertising of prescription drugs because false and misleading ads can lead to injuries and deaths, Public Citizen's Dr. Sidney M. Wolfe told the Senate on July 24.

Drug advertising has more than tripled in dollar volume, from $791 million in 1996 to $2.5 billion in 2000, but the number of warning letters and notices of violation issued by the U.S. Food and Drug Administration (FDA) has dropped sharply in recent years. From mid-2000 through mid-2001, the FDA took 74 enforcement actions, less than half (47 percent) of the 158 enforcement actions taken between mid-1997 and mid-1998.

This means that is it likely that prescriptions are being written for drugs that are more dangerous and less effective than doctors or patients realize. Until changes are made, both physicians and patients will be harmed by prescribing decisions based on all-too-frequently false and misleading information from advertisements.

Problems stem from several things:

• First, the FDA lacks enough investigators to monitor ads.
• Second, there are no regulations specifically written for direct-to-consumer drug advertising.
• Third, the FDA has limited enforcement power.

The FDA can issue a violation notice or warning letter but cannot impose civil monetary penalties, which could deter companies from creating misleading ads.

A review of published medical studies showed cause for concern.

In one, consumers believed that the FDA reviews drug ads before they are published or aired and that only the safest and most effective drugs may be advertised.

Public Citizen's Health Research Group July 24, 2001

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