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Pharma is finally feeling the ill effects of the US economic downturn. In response, many companies are restructuring and downsizing. But pharma industry professionals are well positioned to take advantage of many avenues of employment, including other industries, entrepreneurial ventures, and consulting.

An FDA advisory committee is recommending that over-the-counter painkillers bear stiffer warnings in light of continued episodes of liver and other internal organ damage when consumers take the products in combination with other medications.

Multi-tier formularies that set higher co-pays for the most expensive pharmaceuticals reduce beneficiaries' overall spending on prescriptions.

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.

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.

Instead of developing innovative therapies, pharma companies devote most of their resources to modifying existing medications, according to a report from the National Institute for Health Care Management Foundation (NIHCM).

Many more high-risk patients could benefit from statin therapy than currently receive the cholesterol-lowering drugs, according to a major UK study set up by the Medical Research Council and the British Heart Foundation.

Successful partnerships with third-party organizations such as patient and caregiver advocacy groups, professional associations, and thought leaders are powerful medicine for pharma companies.

Pharmaceutical companies and their marketing partners face a common dilemma: how to translate scientific progress into market success. Despite huge investments, R&D never seems to produce an adequate number of products with blockbuster potential.

A CenterWatch survey of 545 European clinical trial investigators named the best pharma companies to work with in clinical development.

Shares in Danish company Novo Nordisk took a hit after it suspended trials for one of its main pipeline candidates, the dual-acting insulin sensitizer, ragaglitazar.

Spurred by concerns about rising drug expenditures, the Netherlands' government has introduced a list of "lifestyle" medicines that it intends to stop covering with its basic health insurance.

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.

Pharma companies invested a hefty $12 billion in promoting to physicians and consumers in 2001, according to Scott-Levin. But after the highs of 2000, spending in 2001 seemed stunted-a growth rate of 9 versus 13 percent.

Sixteen years ago I began to edit Pharmaceutical Executive, a magazine unknown to me only a few months before. Today, I wonder how much I've learned in all the time since.

The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes on.

The Enron/Arthur Andersen debacle has been a painful warning that there is more to analyzing corporate performance than the smoke and mirrors that often pass for accounting and financial scrutiny. Indicators such as brand value, new product revenue, presence and percentage of business conducted in the US market, and sales growth provide more reliable criteria for companies' short and long-term prospects.

As healthcare struggles to reinvent itself, a confluence of major societal forces has irrevocably changed both the business world and the healthcare landscape.