News Articles

Pretoria, South Africa-Few people noticed that the ground had begun to crumble under Big Pharma when, after the failed World Trade Organization talks in Seattle, Washington, the Clinton administration indicated that it would take note of the effects of its trade policies o­n healthcare in developing countries.Multinational companies had hitherto been able to take the support of governments for granted when it came to policing intellectual property, but Clinton's move indicated a major shift in policy. Few noticed, because the rhetoric wasn't immediately matched by reality. In fact, the US government continued to pressure countries whose intellectual property protection seemed too weak.

In a new twist o­n "direct mail campaigns," marketers at Eli Lilly have taken DTC to an unprecedented level. The company is currently under investigation by the Florida attorney general for allegedly mailing Prozac Weekly (fluoxetine) to a woman who did not have, or request, a prescription for the product. The investigation stems from a privacy invasion lawsuit that the Florida resident filed against Lilly, Walgreens, a local hospital, and several doctors-for misusing her medical history and engaging in the unlawful practice of medicine.

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The common technical document (CTD) and other initiatives to standardize regulatory information processing worldwide can reduce costs and accelerate time-to-market opportunities. But emerging formats, such as the electronic version of the CTD (e-CTD) may also result in internal competitive benefits, such as knowledge management and organizational compliance. This article describes how the critical need to share compliant regulatory information, not o­nly within the pharma enterprise but also across the globe, is driving new submission format and transport specifications.

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Kiln, a Lloyds of London underwriter, has come up with a novel way for pharma companies to mitigate the risk of patent challenges: insurance. Kiln created a policy for a big pharma company covering a number of patents and trademarks the company considers essential for its future profitability. "The exposures are enormous," explains a spokesman for the underwriter. "Patent challenges were treated very much as a commercial risk in the past. Insurance will give a cash value if the goodwill ceases to exist."

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Joanna Breitstein
Pharmaceutical Executive, Jul 1, 2004

The American Medical Association launched a new company with data-integration firm Axciom to sell information from AMA's 870,000-file database of physicians. The Chicago-based 50/50 joint venture, HealthCarePro Connect, will use AMA's files to create a customized database that it claims will benefit both marketers and doctors. The service's advantages to marketers are obvious-they will be able to access the member data of o­ne of the largest and most respected healthcare organizations, providing a o­ne-stop source of potential promotional targets. But HealthCarePro Connect claims it will also make the service attractive to the physicians o­n its call list. According to the company, Axciom's proprietary software AbiliTec will manage the data while guarding its privacy.

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The pharmaceutical industry is experiencing unprecedented late-stage setbacks, product recalls, and difficulties in generating high-quality drug candidates. The problems are not specific to any o­ne company or research effort but rather a result of the industry's limited knowledge of biology and chemistry. (See "Depth of the Problem," page 47.) Therefore, a key challenge is the industry's ability to transition to "new biology" -- genomics and proteomics -- which seeks to understand the causes of diseases through their biological structures and functions at the cellular level.

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The prices of the 50 most prescribed drugs for senior citizens rose, o­n average, by nearly three times the rate of inflation last year, according to a new report released by the Washington-based advocacy group Families USA. The study analyzed price increases for the 50 most commonly prescribed drugs for seniors in the last year (January 2001 through January 2002), in the past five years and in the past ten years. The report found that last year, nearly three quarters (36 out of 50) of these drugs rose at least o­ne-and-one-half times the rate of inflation, while over o­ne-third (18 of 50) rose at three or more times the rate of inflation.

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Sibyl Shalo
Pharmaceutical Executive, Jun 1, 2002