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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.

In case anyone missed the recent wave of studies and reports documenting rising expenditures on medicines, Families USA weighed in with an analysis that further documents rising prices of medicines prescribed for the elderly. The report surfaced just before the US House of Representatives voted on a Medicare pharmacy benefit and was timed to influence that debate.

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.

July 2002 CE.

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.

The Australian government has an unusual plan for reducing prescription drug costs: enlist the help of pharma sales reps to explain the country's pharmaceutical benefits scheme (PBS) prescribing requirements to doctors.

As part of an aggressive campaign against the rising cost of medicines, AARP, the national advocacy group for Americans over 50, joined three class-action lawsuits against pharma companies involving alleged anticompetitive efforts to block generic competition and inflate prices.

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:

Just before the Memorial Day recess, Congress approved legislation to enhance public health agencies' ability to respond to bioterrorist threats. A key addition to the bill reauthorizes the Prescription Drug User Fee Act (PDUFA) for five years. The revised program significantly increases companies' fees to support expanded FDA operations, gives the agency more flexibility in using fee revenues, and backs new initiatives to streamline the drug development and approval process.

Marketing exclusivity is the lifeblood of the US pharma industry. Every day a brand-name drug is on the market without generic competition brings tremendous revenue to its manufacturer.

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.

For companies producing contraceptives, April brought good news and bad news. The good news for Schering AG is that the UK anti-abortion group, the Society for the Protection of Unborn Children, lost its latest legal battle to stop over-the-counter sales of the company's "morning after" pill. SPUC claims that Schering's Levonelle (levonorgestrel) is not a contraceptive but an abortifacient and, therefore, should not be taken without the written consent of two doctors. Levonelle has been available in the United Kingdom without a prescription since December 2000.

Despite generics' increasing market share and the slowed pace of blockbuster discoveries, the industry has reason for optimism. A recent IMS World Review report shows that audited global pharmaceutical sales grew 12 percent in 2001.

After last year's anthrax scare, people desperately began stockpiling Cipro (ciprofloxacin) and other products to prepare for bioterrorism attacks. Not wanting to bother with a visit to their doctor and not willing to pay the product's high retail price of several dollars a pill, they began ordering Cipro-or what they believed to be Cipro-online, from dozens of websites offering it at discounted rates. The problem is, there is no guarantee they were getting the real thing.

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.

Question: When does the Right mirror the Left?And they are. Answer: When they're both attacking the pharmaceutical industry.

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.

One of the Hatch-Waxman Act's authors opposes proposed changes to the 1984 legislation.

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.