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FDA REJECTS OTC STATUS FOR CONTRACEPTIVE The FDA has rejected the over-the-counter sale of the emergency contraceptive levonorgestrel (Plan B; Barr), despite the positive decision given by

the advisory committee. The committee voted 22 to 5 that the non-prescription-setting programme was adequate with respect to consumer access and safe use. However, the FDA said that Barr had

not shown that adolescent women could understand the product instructions without the intervention of a physician, the first time that the FDA has requested this information for an OTC

product. The agency has vigorously defended accusations that the decision was politically motivated. OFF-LABEL USE OF GABAPENTIN REPRIMANDED Pfizer has pleaded guilty to illegally promoting

off-label uses of gabapentin (Neurontin). The drug, developed by Warner Lambert, is approved for partial seizures and post-herpetic neuralgia, but is promoted for at least 11 off-label uses,

including restless leg syndrome, bipolar disorder and migraines. David Franklin, a medical liaison expert for Warner Lambert, successfully charged Pfizer with using fraudulent scientific

evidence, such as suppressing study results and using ghostwriters, to promote the off-label use of the drug. Pfizer agreed to pay a total of US $430 million in fines and damages — the

second largest given in the industry. APPROVAL FOR NEW ANTITHROMBOTIC AstraZeneca's keenly awaited thrombosis drug ximelagatran (Exanta) has received the first round of approvals in the

European Union. Ximelagatran, the first alternative to warfarin for 60 years, was approved for the prevention of thrombosis in patients undergoing hip and knee surgery. The United Kingdom

and Ireland have not approved the treatment, as they want to discuss the timing of its use. But AstraZeneca says the countries have not questioned the safety or efficacy of the treatment.

FIRST STATIN TO BE SOLD OVER THE COUNTER The United Kingdom government announced that Merck will get the go-ahead to market a 10-mg dose of simvastatin, known as Zocor Heart Pro, over the

counter in UK pharmacies. Statins are prescribed to 1.8 million UK patients at a cost of more than £700 million (US $1.25 billion) to the National Health Service. The government is hoping to

make simvastatin available for primary prevention of heart disease to a broader population without costing the government any extra money. In the highly competitive statin market, Merck

hopes that the move will help rejuvenate sales of its off-patent product. The UK is the first country to sell an OTC statin, and it will be available in July for reducting the risk of a

first major coronary event in people likely to be at moderate risk of coronary heart disease. PFIZER SHIFTS R&D STRATEGY Pfizer's CEO Hank McKinnell said the company is moving from

short to longer term R&D by seeking biotech acquisitions to fill its pipeline. Several of Pfizer's most important drugs are expected to lose patent protection in the next few years,

and the move from in-licensing to improving core R&D capabilities seems to be due to the current favourable climate for making value-for-money acquisitions. Pfizer hinted at its

intentions last year when it acquired the US biotechnology company Esperion for US $1.3 billion. NIH ADDRESSES STAFF CONFLICTS OF INTEREST A National Institutes of Health (NIH) panel has

proposed changes to its employment rules to address criticism about conflicts of interest among its senior staff. The changes were proposed after an article in the _Los Angeles Times_ in

December 2003 suggested shortcomings in the agency's existing conflict-of-interest policies. The panel said the NIH should bar its most senior officials from earning money by consulting

for industry or academic institutions. It recommended that scientists who are allowed to do consultancy work should limit their compensation to 50% of their government salaries and spend no

more than 400 hours a year on the work. Nobody at the NIH should be allowed to accept stocks or stock options as payment, but the health secretary should raise the cap on the salaries as a

recruitment incentive. ANTISENSE CANCER DRUG SHOWS NO EFFECT ON SURVIVAL The antisense treatment for BCL2, oblimersen (Genasense; Genta/Aventis), seems not to have an effect on

progression-free survival, according to an FDA Advisory Committee. The committee voted 11 to 5 that oblimersen plus dacarbazine showed a difference in response rate from dacarbazine alone in

patients with metastatic melanoma. However, the committee voted 12 to 4 that the Genta pivotal trial did not conclusively show a “real effect” on progression-free survival. Genta has

withdrawn this application for approval and reduced its workforce by nearly a half. The company has stopped marketing gallium nitrate (Ganite) for hypercalcaemia, which was intended to help

establish its sales force before the launch of oblimersen. This now allows for the company to devote its remaining money — an estimated US $67 million — to resubmitting approval data for

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