For one thing, companies now include additional information on the label, such as drug/drug interactions and information on
how to optimize use in various subpopulations. In addition, the use of labeling in product liability and medical malpractice
lawsuits, coupled with increasing litigation costs has caused manufacturers to become more cautious and include all known
adverse event information—regardless of its importance or its plausible relationship to the drug.
Finally, accelerated approval ofcertain drugs for serious illnesses has resulted in the rapid availability of products for
which more timely and expanded information about benefits and risks is necessary to help ensure safe and effective prescribing.
Lester Crawford recently noted that drug labels should change. What can we expect? The FDA has published two important initiatives. First, the agency is proposing to amend its regulations governing the format
and content of labeling, to require labeling new and recently approved products. It would include one section containing highlights
of prescribing information and another section containing an index to prescribing information, and it would also reorder currently
required information. These revisions would make it easier for healthcare practitioners to access, read, and use the information,
and it would enhance the safe and effective use of prescription drug products. Second, in 2005 FDA will mandate the Structured
Product Labeling (SPL) standard for electronic submissions. SPL will improve the integrity of product information through
the use of consistent structure and standard terminology. It will also facilitate review, storage, and distribution of labeling
content; ensure machine processibility of labeling content; and improve timeliness of availability of product labeling to
improve patient safety. We're playing an active role in helping pharma companies implement and meet SPL requirements.
What trends in healthcare have affected your business? Over the last 60 years, the molecule has replaced the surgical blade. There are many more drugs available to patients today,
and as a result, more information. Add to that the internet and mobile technologies, and clinicians have changed the way they
access and use information at the point of care.
Although technology is wonderful if it is used correctly, access to information can also be a thorn in the physician's side.
Just look, for example, at the less than perfect content that was on the internet a few years back. That drove us to leverage
the PDR for physicians into the patient environment with
http://www.PDRhealth.com/. so patients can get medical information from the same trusted source as their physicians. Today, 66 million US households
recognize and value the PDR name. And we will continue to invest in the patient and caregiver segments to allow our pharma
customers additional opportunities to educate the people who come through that channel.
What about the rise of managed care? That, too, has had an impact on our business. Because of the pressures of managed care, more doctors are becoming "hard-to-see"
or "no-see" physicians. If physicians decide not to see detail reps, then we ask how we can help companies effectively use
the PDR and our online channels to educate doctors on those therapeutic areas. Our goal is to work with our pharma customers
to create new and creative value-added solutions that physicians can integrate into their workflow. That's why we introduced
an e-sampling solution, and we will also launch an e-detail solution. Physicians, at their convenience, can come to PDR.net
and participate in an e-detail. At the end of that detail, the physicians are asked if they want a sample. Our program then
asks physicians if they want a rep to drop off the sample or have it mailed to them. We will also release formulary information
on PDR.net and mobilePDR in first quarter 2005. So when physicians are at the point of care, they will know which medications
are on the patient's health plan before prescribing it.
What other new products are coming out? We are involved in an exciting opportunity driven by PhRMA and other industry stakeholders in which PhRMA is conducting a
large-scale field trial (LSFT) to demonstrate that delivering drug labeling electronically is more efficient and effective
than traditional paper labeling. The organization is using PDR On-Demand, our paperless labeling solution, which can facilitate
access to the very latest labeling, thereby promoting greater patient safety; increasing new drug revenue by eliminating delays
in distributing labeling to dispensing sites; and significantly reducing costs of labeling distribution, which for many companies
totals millions of dollars annually. We are testing PDR On-Demand at 126 geographically and operationally varied dispensing
sites. Data from this LSFT will be used to support a change in regulations to allow omission of paper package inserts. So
We are monitoring the e-prescribing space closely. We view it as an opportunity to reduce medication errors by using the PDR
drug information when communicating prescription information electronically between prescribers and pharmacies. We are also
looking at ways to help physicians obtain and maintain their credentials with health plans and medical institutions. Of course,
we are keeping our eye on the evolution of PDAs and tablet PCs and things that we believe will eventually integrate into physicians'