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Croatia's Pliva Pharmaceuticals is the first eastern European pharma company to make a US acquisition. Pliva paid $153 million for New Jersey-based Sobel Holdings,

Many industries today are looking to mobile and wireless solutions or handheld devices to improve business efficiencies, create more effective customer interactions, and deliver business value.

The debate about direct-to-consumer (DTC) advertising of prescription medicines and internet information about therapeutic products is heating up again. Non-product-specific disease awareness campaigns are now allowed. In fact, Europeans were recently treated to retired Brazilian soccer star Pel¨sponsored by Pfizer) urging the afflicted to seek help for erectile dysfunction during World Cup commercial breaks .

The United Kingdom's much-maligned National Institute for Clinical Excellence (NICE) could be in line for a shake-up if the recommendations of a House of Commons select committee go through.

In response to concerns about the low level of patient participation in clinical trials, the British Medical Association has launched an internet resource aimed at encouraging more patients to take part. Aimed at healthcare professionals, the site explains how different types of trials are conducted and spells out their ethical and best practices requirements.

Parma sales reps have long been using customer relationship management (CRM) systems to detail doctors and provide them with samples. But it was not until late 2000, when FDA initiated the final rule of 21 CFR Part 203 and 205, enforcing the Prescription Drug Marketing Act (PDMA) of 1987, that the industry grew attentive to the regulations governing CRM systems, also known as sales force automation (SFA) or sales force effectiveness (SFE) systems.

The House leadership collected just enough votes in late June to approve a Medicare reform bill that provides some coverage of pharmaceuticals for seniors. Democrats rebuked the measure as a scam and a fraud; some conservatives complained that it opened the door to a costly new entitlement.

To win consumers' trust and loyalty, pharma companies should look to the privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to guide their direct-to-consumer (DTC) and web strategies.

In a closely watched patent case that has important implications for pharma companies, the Supreme Court ruled unanimously in May to uphold policies that protect patent holders from imitators. The decision, in what is considered one of the most significant patent disputes to come before the court, is expected to benefit brand-name companies that bring patent infringement cases against generics makers.

Setbacks sometimes prompt a great leap forward. For Sankyo, a major product withdrawal-most painfully, of its potential blockbuster for diabetes, Rezulin (troglitazone)-created the reversal. Major liver effects appeared in the market

This season, boosterism is out; hedging is in. Yet a realistic assessment of the pharma market, even under the shadow of terror and war, reveals new opportunities. For every ominous sign or setback, a potential line of offense exists. Despite the press of a slow economy, nervous investors, customer consolidation, and cost-shifting in healthcare, the industry remains rich in resources, growth, and opportunity. Here are some of the market forces, issues, and opportunities for the pharma universe this year:

With the huge costs of developing a new drug from scratch and the high attrition rates as lead compounds fail during the trials process, in-licensing has become an increasingly popular method for pharma companies to boost their pipelines without all of the outlay involved in de novo research.

FDA has issued the industry a new charge-pay closer attention to risk management. Now that prescription drug user fees have helped the agency approve candidates more rapidly, FDA has returned to its basic mandate: assuring that marketed pharmaceuticals are safe. In the past, that meant clear labeling with adequate directions and warnings based on clinical trials. The agency now believes that product safety extends beyond warning labels and wants to ensure that prescriptions are used safely as well. As a result, it is asking the pharma industry to demonstrate products' safety before approval and to further control their use after

A former Warner-Lambert employee has blown the whistle on the company's "shadowing program," alleging that some physicians accepted money in exchange for allowing pharma sales representatives to meet with patients, review charts, and recommend prescriptions. According to the lawsuit, Warner-Lambert-since acquired by Pfizer-tried to boost sales of its epilepsy drug Neurontin (gabapentin) by tracking prescriptions and rewarding high-prescribing physicians with gifts such as cash, trips to resorts, and lucrative speaking and consulting jobs-as well as paying them to enter patients in clinical trials. The program allegedly paid 75-100 US doctors at least $350 per day to let sales reps watch

The decoding of the human genome and its potential to open the door to cures for AIDS, cancer, and many other conditions that today are incurable are likely to shapethe healthcare industry for decades to come.

In today's legal climate, pharmaceutical companies are prime targets for litigation in both state and federal courts. Because they are engaged in product research and development and related complex business practices spread across many jurisdictions and because the public perceives the industry as having deep pockets, executives must be prepared for-and frankly must expect to face-the challenges of major multijurisdictional litigation.

Does FDA harm patients by rushing unsafe products to market or by slowing product development and approval? That debate came to the fore recently with the almost simultaneous release of competing studies.

Terminally ill patients often wonder about the roles of timing and fate in determining their life's course. If only they had been tested or diagnosed earlier; if only the doctors had found the tumor before it metastasized. As purveyors of science and administrators of public health, the world's pharma companies and physicians struggle to intervene earlier-indeed to predict and prevent disease-before it's too late.

In April, a distinguished group of scientists and legal experts gathered in San Francisco to discuss two of the most exciting and controversial research topics of the century: stem cell research and xenotransplantation.

During the next three years, an estimated $38 billion in brand-name pharmaceuticals will come off patent, leaving a financial void that many pharma companies hope to fill with functional genomics.

Pricing has never been more of a key issue for the industry than it is right now. Yet, even with the increased importance of pricing strategies, a lack of focus on critical market factors leads many manufacturers to forego profits or increase their vulnerability to aggressive payers. Aligning pricing and contracting can achieve a sustainable competitive advantage-if product managers objectively assess a product's clinical benefits and address two key questions:

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity. Consequently, contract research organizations (CROs) have struggled to find their footing in a business where the number of customers has shrunk and the demand for speed and cost-effectiveness has risen. Delivering service excellence when customers' names and addresses are changing regularly is a challenge, resulting in disrupted continuity, broken lines of communication, and policies and relationships thrown into disarray.

First Amendment protection of commercial speech got a big boost last month when the US Supreme Court ruled 5-4 that FDA's policy to limit advertising for pharmaceutical compounding is unconstitutional.

International trade rules play a large role in creating world poverty, according to Oxfam, an international confederation of organizations committed to end poverty. In a recent report, "Rigged Rules and Double Standards," the group accuses rich nations of robbing poor nations of $100 billion a year by abusing trade rules. It also criticizes pharma for enforcing its patents in poor countries.

The past few years have seen a steady increase in new medicines being discovered and developed in the United States and a decrease in those from Europe, where it takes much longer for new medicines to become available to patients. In some cases, it takes medicines three or four years from their approval date to reach the market in all European Union member states. So, in March 2001, the European Commission appointed a high-level group to address those issues on a Europe-wide basis, involving all the different member states and stakeholders.

The National Institute of Health Care Management made headlines with its report on double-digit increases (17 percent) in retail spending on medicines in 2001. The total reached $155 billion last year, almost double the $80 billion spent in 1997, according to the study, "Another Year of Escalating Costs." PhRMA president Alan Holmer said the increase is a good thing, signifying that more people who need medicines for chronic conditions are being treated and thereby avoiding more expensive medical procedures.

African-American physicians regard direct-to-consumer advertising of prescription medicines as one way to educate minority patients about needed treatment and healthcare options, according to a survey conducted by the National Medical Association (NMA). Almost all of the 900 physicians answering the questionnaire reported that DTC advertising has prompted patients to ask questions, and one-third acknowledged that they feel additional pressure to justify their prescribing decisions. But almost half (48 percent) said that such promotion increased communications between physicians and patients.

Among the dozens of initiatives in Washington affecting the pharma industry, one common thread is the growing movement to control accelerating expenditures for prescription medicines.