PHARMACY

FDA’s Woodcock points to science as reason for fewer drug approvals

BY Drew Buono

WASHINGTON The Food and Drug Administration has been criticized recently by the pharmaceutical industry of rejecting or delaying new drug approvals because the agency was too risk-averse, partly in response to politicians and consumer groups who have attacked the FDA for approving medicines that have later proved to have dangerous side effects like the painkiller Vioxx and the diabetes medication Avandia.

The new head of the Center for Drug Evaluation and Research, Janet Woodcock, has come back, stating that science is the cause for the lack of new medicines, not pressure, according to an interview in the Financial Times. She said that when the FDA rejected new medicines, it did so based on an assessment of their safety and efficacy, not as a result of political pressure or greater conservatism.

Woodcock also stated that she was concerned about post-marketing surveillance studies on drugs because of the length of each study.

She also said the FDA would unveil new proposals in the fall on reducing drug developing costs by standardizing the format and content of clinical trial data. “We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it.”

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PHARMACY

Study offers insights into cell growth ‘on/off’ switch

BY Drew Buono

DURHAM, N.C. According to a study published in the April issue of the journal Nature Cell Biology, new information has been found about an on-off switch that controls cell growth could one day help identify targets for drugs to treat cancer and other diseases that involve unnatural cell growth.

If the switch is “on,” then a cell will divide, even if it’s damaged or the signal to grow disappears, according to researchers at the Duke Institute for Genome Sciences and Policy.

The on-off switch is part of the pathway that controls cell division, the process that creates new cells. Before a cell divides, it goes through a checklist to make sure everything is in order. If the cell senses a problem early on, it can halt the process. But once the cell passes what’s called the restriction point, it can no longer stop division. This on-off switch controls the restriction point and therefore plays an important role in cell growth, according to the study.

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Biotech firms spent $58.8 billion on R&D in 2007

BY Drew Buono

SAN FRANCISCO According to an analysis by Burrill and Company and the Pharmaceutical Research and Manufacturers of America, the biotech industry’s investment into research and development of new medicines was $58.8 billion in 2007.

The report also showed the PhRMA-member companies spent about $44.5 billion on research and development last year by themselves; this was a slight increase from the record number of 2006 which was $43 billion. Non-PhRMA companies spent about $14.3 billion, up from $12.2 billion in 2006.

“America’s biopharmaceutical research companies continue to pave the way for the development of future treatments and cures,” said PhRMA president and chief executive Billy Tauzin. “Simply put, R&D is the lifeblood of U.S. pharmaceutical innovators. Last year’s investment builds on over 25 years of growth in R&D spending as our researchers continue the search for new and improved therapies to tackle a wide range of diseases and conditions such as cancer, heart disease, HIV/AIDS and Alzheimer’s.”

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