FDA sees huge opportunities in opening up drug data

LONDON (Reuters) - Regulators and drugmakers need to find ways to make more clinical data openly available, since vital knowledge about fighting disease is often locked away in confidential databases, the head of the U.S. drugs watchdog said on Monday.

Food and Drug Administration (FDA) Commissioner Margaret Hamburg said opening up data to public scrutiny needed to be done selectively, given legitimate concerns among companies over commercial confidentiality, but more could still be done.

"We really need to work -- industry and regulatory authorities -- on how to handle data," she told the FT Pharmaceutical and Biotechnology conference via a video link from Washington.

"There are, if you look at the big picture, huge opportunities to open up some of that data for greater analysis and provide broader benefit to our understanding of the science of these products."

In particular, making detailed data available on how experimental drugs have performed in clinical tests, which are then filed with regulators, could prevent scientists from pursuing dead-end areas of research, she added.

Campaigners have long pushed for the FDA to disclose full explanations and accompanying data when it rejects new drugs, but the agency's hands are tied by the need to protect company confidentiality.

Hamburg said the pharmaceuticals sector, faced with declining productivity and rising costs in recent years, was now at a critical juncture, requiring greater collaboration and a more imaginative approach by manufacturers.

And by sharing more knowledge, drugmakers in future should be able to improve their success rates.

"By opening up some of these databases in careful ways we might be able to benefit the medical product development enterprise overall and ultimately benefit patients," she said.

Her comments chime with a growing interest among drug companies on novel ways to conduct research, including the possibility of greater co-operation at the pre-competitive stage.

Although exclusivity and patents are the lifeblood of the drugs industry, some experts argue that building walls around science is counter-productive because companies end up working in parallel and duplicating research.

The FDA oversees about 25 percent of the U.S. economy including prescriptions and over-the-counter drugs, medical devices, most foods and many other consumer products.

Under Hamburg's watch, the agency has become more aggressive in its oversight of companies for product safety problems, shoddy manufacturing and misleading advertisements.

She has also promoted investment in better scientific tools for drug development and safety monitoring.

(Reporting by Ben Hirschler; Editing by David Hulmes)