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Life Science Firms: FDA Improving but Still Not There

Calculator keys (Investor.gov)

(Investor.gov)

A survey of 50 life science companies conducted by the consulting firm PriceWaterhouseCoopers says the companies feel they have better working relationships with the U.S. Food and Drug Administration (FDA), but they say the agency still does not have adequate resources or is up to speed on advancing technology. The survey was sent electronically to potential respondents, including companies that develop biologic, drug, and medical device products in the summer of 2010.

Nearly four in 10 (38%) of the responding companies said they feel that their overall working relationship with FDA has improved over the past two years, and eight in 10 said that FDA is providing better guidance about its expectations. Two-thirds (68%) of companies said they are incorporating this feedback into product development.

Almost as many (64%) of companies said that meeting with FDA before submitting review materials improved the quality of their applications, and nearly nine in 10 (87%) said it expedited their applications. But industry does not always take advantage of these meetings, and only about half (53%) said FDA consistently encouraged these meetings.

Despite improving relationships with the FDA, the companies still report that FDA is not always clear or consistent in their reviews. Six in 10 companies expressed frustration that FDA had changed its position during a review, and four in 10 feel that some products were denied because of FDA’s inadequate review resources.

The companies generally feel that FDA is not keeping up with rapidly advancing technology. Only 8% of drug and device makers think FDA is doing enough to advance personalized medicine. More than half (56%) of respondents who are familiar with the FDA’s Critical Path Initiative to bring innovative, high priority therapies to market quickly think that FDA currently lacks the capability to implement the initiative.

In a separate survey of 1,000 adults in the U.S., the vast majority of Americans (93%) are confident about the safety and effectiveness of drugs and medical devices approved for use in the United States, and two-thirds agree that the US has the highest standards in the world for drug safety and effectiveness. More than half (56%) of Americans, however, said they would be willing to use drugs and devices approved outside the US, before they are approved by FDA.

The survey also showed the public is not aware of the the long timetable — about 12 years — needed to bring a drug to market. About half of those surveyed (54%) think it takes five years or less to develop a new drug or medical device.

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