Friday, June 16, 2006

AMA Adopts Moratorium Policy

AMA Adopts Moratorium Policy
Bob Ehrlich, Chairman
DTC Perspectives, Inc.

As discussed in a recent column, the American Medical Association (AMA) did consider a DTC moratorium resolution this week at their annual meeting. The result was a compromise that is sensible. Instead of calling for a set time period for all new drugs, the AMA is asking for a negotiated moratorium period between the drug maker and FDA.
This makes sense since not all new drugs present the same risks. A new statin drug poses less risk than a first in class cholesterol drug. A new cancer drug is likely to have more risks/side effects than a new antihistamine. Clearly, negotiation of a moratorium between experts makes more sense than Congress legislating a blanket time period.
Perhaps a minimum period of 6 months makes sense for any drug, with longer periods to be negotiated if warranted. Letting the FDA negotiate gives tremendous power to the agency since it can withhold approval if the time period agreed on by a drug maker is not to their liking. I would like to see how this works, and one hopes FDA would not be unreasonable.
It is important that drug makers retain the right to advertise their products, and even drugs in new classes should not have to wait long periods. I propose a maximum period of 18 months which would allow significant physician experience and identification of clinically unseen side effects.
The AMA call for a moratorium will carry significant weight in Congress, and I expect some time period to be adopted as part of drug safety legislation. It is not what drug makers want, but I think a reasonable policy will not be fought by the industry. A negotiation between drug maker and FDA seems fair and should not lead to major problems. A moratorium should strengthen consumer confidence in the safety of advertised drugs, and this may, in fact, increase sales.
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