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.

Web most effective for getting consumers to request specific Rx

Web most effective for getting consumers to request specific Rx

The Internet is the most effective channel for getting consumers to ask for a specific drug, according to a new survey from market research firm MRx Health and Medical Marketing & Media. The survey of 546 U.S. adults found that 34% of respondents said ads on the Internet had the biggest impact on whether they asked for a drug. Television, by comparison, had less of an impact (31%). TV also ranked lower than family and friends (33%). Other channels commonly used by pharma were the least effective, including telephone support lines (2%), newspapers (3%), and radio (4%). One-third of respondents said they are interested in prescription drug ads. However, those in poorer health are almost twice as interested as the healthiest group (45% vs. 24%). Of the patients who have asked their doctor for a specific drug, 87% said they have received it.

iPods double as patient-education, detailing tools

iPods double as patient-education, detailing tools

iPods aren't just for music for anymore; they can save lives, according to Grant Winter, president of The Manhattan Bureau, a news-based video production company. They can be used to store medical information, act as medication reminders, and be used by physicians to explain diseases and treatment to patients, he said yesterday during Pharmaceutical Executive's Marketing and Sales Summit. Pharma can produce reliable, peer-reviewed information in a video format with accurate, unbiased material for physicians to use to better inform patients within their time-constrained appointments. With physicians trying to see more patients, and patients often coming in armed with the wrong information from the Web, physicians need a way to quickly and clearly educate them on their disease or treatment. Winter said that most pharmas are beta testing video material for sales reps to use on iPods, and the value is in the continual updating of information. "Every time you plug your iPod into your computer, the data is automatically updated," he said.