MedGuide on the Brink

By Conlan, Michael F | Drug Topics, June 24, 1996 | Go to article overview

MedGuide on the Brink


Conlan, Michael F, Drug Topics


FDA's patient

information plan

seems headed

toward defeat

MedGuide is on life support, and pharmacy groups are working to make sure Congress fully pulls the plug. The House of Representatives has voted to deny the Food & Drug Administration use of funds to go forward with MedGuide, a program that would require retail pharmacies to give patients FDA-approved written information with each new prescription.

The House-passed ban would permit the agency to require warnings "in specific instances where they believe it is a life-or-death situation," under an amendment offered to FDA's fiscal year 1997 budget in the Appropriations Committee by Rep. Richard J. Durbin (D, Ill.). The agency already requires patient information leaflets for Rxs that pose serious and significant public health concerns. Examples include estrogen products and oral contraceptives. On occasion, it also has asked manufacturers to voluntarily include patient package inserts for some Rxs, such as for Accutane (isotretinoin, Roche), which warns of risks associated with pregnancy.

Given the antiregulatory stand of most of the Republican Congressional majority, MedGuide's demise seems likely. Agency budgets fall into the "must pass" category of legislation, and a key member of the Senate Appropriations Committee already has expressed serious reservations about the FDA proposal. "Government intervention in this area is unnecessary because voluntary, private-sector initiatives are already working to provide high-quality oral and written patientspecific information to individuals about their prescription medications," Sen. Thad Cochran (R, Miss.) wrote FDA commissioner David A. Kessler.

Cochran said the marketplace was meeting the need for useful written information on Rxs and urged him "to withdraw this unnecessary, burdensome rule on the nation's retail pharmacies." Earlier this year, the Senate's version of FDA reform was amended to make MedGuide's goals a voluntary, private-sector initiative. But since enactment of FDA reform legislation this year is increasingly problematic, MedGuide opponents also pushed the appropriations route. And the opponents were many.

They include all pharmacy associations, as well as the Pharmaceutical Research & Manufacturers of America (PhRMA). They insist that they are not against giving patients more and better information about their medicines and, in fact, increasingly are doing so voluntarily. But they question FDA's approach and its consequences. "The scientific research on effective communication of drug information to consumers shows that a few minutes of direct face-to-face education is far more effective than boilerplate written handouts," John A. Gans, executive v.p. of the American Pharmaceutical Association, said in a letter to Rep. Thomas Bliley Jr. (R, Va.) last month.

"The FDA's regulation would elevate the least effective means of communicating with patients-these 'onesize-fits-all' leaflets-to a national legal standard," wrote Gans. "The predictable consequences of this regulation are litigation against pharmacists who are true patient educators, seeking to force them to distribute paper handouts that meet bureaucratic standards, and a flurry of state legislation to reassert the traditional role of state professional licensure boards in regulating pharmacy practice. …

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