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Managed care organizations (MCOs) and pharmacy benefit managers (PBMs)-representing 110 million US patients-have adopted new guidelines for formulary submissions. As a result, they now reject 40 percent of new drugs. Those standards, the most visible component in an approach called outcomes-based access, indicate a revolutionary change in the formulary decision making process that affects 46 percent of the insured population. Many pharmaceutical companies are being caught by surprise.

Employees in the pharma industry, who once expected lifetime employment, now find themselves facing some of the same dilemmas, including job insecurity and declining stock values, as those in beleaguered industries such as defense and finance. The pharma industry has seen more than its fair share of mergers and acquisitions, and employees increasingly question whether they have a future within their company. Those who make the hiring decisions for large pharma companies say such doubts are reasonable in the current climate and that an honest self-assessment of a variety of factors, including faith in management, opportunity for growth, and job

PR is more than free ink. It is even more than good free ink.

Current lawmakers make frown on cannabis use, but for thousands of years people used it to treat conditions as diverse as rheumatism, convulsions, tumors, and pain. Now the small, private UK company Oxford Natural Products has completed Phase I trials on a cannabis derivative for treating post-operative and cancer pain.

Don't expect us to launch products in the magnitude of a billion dollars in sales. For us, a product is very interesting at $200 or $300 million."

Patents help ensure that companies can recoup their development costs-and make profits-by selling their products without competition for a set period of time. The pharma industry has followed that model for decades.

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.

October 2002 CE.

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.

Product development glitches continue to depress share prices at AstraZeneca. Poor trial results for the company's cancer drug Iressa followed hard on the heels of bad news about its cholesterol treatment Crestor (rosuvastatin).

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.

In a volatile and highly competitive market, one way for pharma companies to keep an edge is through better communication. Companies routinely outsource the services and processes involved in the formulation, manufacture, packaging, labeling, and delivery of products. Leveraging the resources of third parties can be both cost-effective and efficient. But not all companies successfully communicate and collaborate with their partners to capitalize on those benefits.

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.

If policy makers crafting a Medicare pharmacy benefit are worried about heavy prescription spending by seniors, they should take a closer look at medication use by the five million disabled beneficiaries in the program of 40 million patients.

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.

September 2002 CE.

The Senate's failure to approve a Medicare pharmacy benefit in August was not a big surprise on Capitol Hill, but it was disappointing to policy makers on all sides. Instead, the legislators adopted measures designed to make pharmaceuticals more affordable for all consumers.

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.