Pharmaceutical Executive-10-01-2002

Companies, like individuals, must stay in shape, and both must search-in an environment of high demands on time and resources-for the right tools to achieve and maintain fitness. The pharma industry's current challenges suggest that the need for fitness may be greater than ever:

A jittery stock market, repeated profit warnings, concern about accounting practices, another industry mega-merger, and a new raft of legislative proposals. Small wonder that US analysts find it difficult to separate the words "troubled" and "pharmaceutical industry."

FDA's September announcement that it plans to transfer some therapeutic biologic review functions from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) caught most agency officials and Washington observers by surprise.

I was wondering whether I could take any more pain, when the moment slowed to a crawl. Pain wakened fear. Eternity lingered alongside. Mortality, grinning over my shoulder, blew a chill breath across the nape of my neck. "Dying would end the pain," I thought. "But I don't want to die like this."

Consumers who lack pharmacy benefit coverage are more likely to ask physicians about the cost of treatments than those who have coverage, according to data from FDA research on the impact of direct-to-consumer advertising.

Rarely does the head of a top pharma company agree to meet with a journalist in the midst of a strategic challenge as large as this one-Merck's plan to establish Medco Health Solutions as a separate, publicly traded company.

Is a pharma website a type of labeling, a form of advertising, or some new hybrid? The industry has used the internet as a communication channel since 1994, yet, after nearly a decade of online medical development and experimentation, none of the major regulators has decided yet-or offered any clear guidance about-what constitutes "acceptable use."

I thought I knew all of the definitions for healthcare compliance when I left my job at a traditional pharma company in 1998 to become chief operating officer of a company that sold both medical diagnostics products and pharmaceuticals.

A major consolidation may be underway in the UK biotech sector. According to a report in London's Financial Times, several embattled companies specializing in cancer medicines are talking about a possible merger. Xenova, British Biotech, Antisoma, KS Biomedics, and Oxford GlycoSciences are believed to be in the early stages of discussions about merging to create a much stronger company.

For everyone from legislators to healthcare payers to corporate executives, generics is the new hot topic. First, the Greater Access to Affordable Pharmaceuticals Act of 2002, which would eliminate the 30-month delay that is triggered when a brand-name company sues a generics maker for patent infringement, passed the US Senate and is under consideration in the House.

In an effort to cope with soaring healthcare costs, more employers are establishing three-tier prescription drug benefit plans for workers.

Acting on the belief that states should respect agency rulings involving labeling and advertising, FDA filed legal briefs challenging judges that second-guess its authority.

For years, medical education activities have been a sure way for pharma marketers to deliver key messages to the medical community about scientific discoveries, new treatments, and products fostering medical advancement. The most effective activities advance physicians' knowledge and motivate them to act.