Pharmaceutical Executive-06-01-2002

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.

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.